Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (PRESERVE-001)

• ClinicalTrials.gov Identifier: NCT04140526
• Recruitment Status: Recruiting
• First Posted: October 28, 2019
• Last Update Posted: March 20, 2023
• Sponsor: OncoC4, Inc.
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): OncoC4, Inc.

Study Description

Brief Summary:

This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer; Advanced Solid Tumor; Metastatic Melanoma; Metastatic Head and Neck Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Colorectal Cancer; Sarcomas; Metastatic Prostate Cancer; Ovarian Cancer; Small Cell Lung Cancer; Metastatic Breast Cancer; Pancreas Cancer; Gastric Cancer; Esophageal Cancer; Gastroesophageal Junction Adenocarcinoma; Cervical Cancer; Adenoid Cystic Carcinoma; Salivary Gland Cancer; Urothelial Carcinoma	Drug: ONC-392; Drug: Pembrolizumab	Phase 1; Phase 2

Detailed Description:

Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), also known as CD152 (cluster of differentiation 152), is a cell surface protein receptor that interacts with B7-1 (CD80) and B7-2 (CD86) to ensure proper function of regulatory T cells and protect host against autoinflammatory diseases. Anti-CTLA-4 monoclonal antibodies (mAbs) have demonstrated strong and broad cancer immunotherapeutic effects (CITE) in a variety of preclinical models and are used clinically both as monotherapy and as part of combination therapy with Nivolumab (anti-PD-1). However, CTLA-4 monotherapy has more immunotherapy-related adverse effects (irAEs) than anti-PD-1/PD-L1 therapy. In addition, the rate of severe irAE (Grades 3 and 4) reached 55% in melanoma patients receiving combination of Ipilimumab and Nivolumab. The strong irAEs further limit the doses tolerated by cancer patients. Nevertheless, combination with anti-PD-1 resulted in significantly improved response rates and patient survival in multiple types of cancer. Furthermore, anti-CTLA-4 antibodies induce long-lasting immunity in cancer patients. Therefore, CTLA-4 remains an important immunotherapy target, but major challenges remain in improving both safety and efficacy of anti-CTLA-4 mAbs.

ONC-392 is a highly selective, humanized monoclonal IgG1-kappa isotype antibody against CTLA-4. The parental clone was identified through in vivo screening in humanized CTLA-4 mouse model for high anti-tumor efficacy and low autoimmune toxicity. We have recently demonstrated that ONC-392 is dissociation from CTLA-4 under low pH to allow its escape from lysosomal degradation and recycle to cell surface. We have provided several lines of evidence for the notion that a pH-sensitive antibody ONC-392 is not only safer but also more effective in Treg depletion and tumor rejection than the Ipilimumab, which is pH-insensitive. First, by preserving CTLA-4 on the cell surface, Onc-392 leaves higher ligand density for better ADCC.

Second, Onc-392 is more efficient in Treg depletion in tumor microenvironment. Third, Onc-392 is significantly more potent in inducing rejection of large tumors.

The study consists of four parts:

(1) The Part A study is a dose-finding rapid titration, Phase I trial of ONC-392 as a single agent in patients with advanced or metastatic solid tumors with various histology. The aim of this trial is to define the recommended Phase II dose for ONC-392 monotherapy (RP2D-M). (2) The Part B study is a dose-finding phase with ONC-392 in combination with a standard dose of 200 mg pembrolizumab in patients with advanced or metastatic solid tumors.

(3) The Part C consists of different expansion arms.

1. Arm A: Pancreatic Cancer Cohort, ONC-392 monotherapy, will enroll advanced/metastatic pancreatic cancer patients who have progressive disease after first and second lines of systemic treatment.
2. Arm B: TNBC Cohort, ONC-392 monotherapy, will enroll advanced/metastatic TNBC patients who have progressive disease after prior systemic treatments, including checkpoint inhibitor immunotherapy.
3. Arm C: NSCLC Mono Cohort 1, ONC-392 monotherapy, will enroll advanced/metastatic NSCLC patients with EGFR or ALK mutations who have progressive disease after prior systemic treatments, including targeted therapy or checkpoint inhibitors.
4. Arm D: NSCLC IO Naïve Cohort, ONC-392/Pembrolizumab combination therapy, will enroll advanced/metastatic NSCLC cancer patients who are treatment naïve, or anti PD (L)1 immunotherapy naïve and PD-L1-positive (PD L1 TPS ≥ 1%).
5. Arm E: NSCLC IO R/R Cohort, ONC-392/Pembrolizumab combination therapy, will enroll advanced/metastatic NSCLC cancer patients who are R/R to prior anti-PD-(L)1 immunotherapy regardless of PD-L1 status.
6. Arm F: Melanoma IO Naïve Cohort, ONC-392/Pembrolizumab combination therapy, will enroll advanced/metastatic Melanoma patients who are treatment naïve, or checkpoint inhibitor immunotherapy naive. Prior systemic chemotherapy or targeted therapy are allowed.
7. Arm G: Melanoma IO R/R Cohort, ONC-392/Pembrolizumab combination therapy, will enroll advanced/metastatic melanoma patients who are R/R to anti-PD-(L)1 immunotherapy.
8. Arm I: NSCLC Mono Cohort 2, ONC-392 monotherapy, will enroll advanced/metastatic NSCLC patients without EGFR or ALK mutations who have progressive disease after prior systemic treatments, including chemotherapy or checkpoint inhibitors. Patient must have anti-PD-(L)1 treatment, either alone or in combination, as last treatment before enrollment. Prior anti-CTLA-4 treatment is allowed.
9. Arm J: Melanoma Mono Cohort, ONC-392 monotherapy, will enroll advanced/metastatic melanoma patients who are R/R to anti-PD-(L)1 immunotherapy.
10. Arm K: Head and Neck Squamous Cell Carcinoma (HNSCC), ONC-392 monotherapy, will enroll advanced/metastatic HNSCC patients with or without positive HPV who have progressive disease after prior systemic treatments, including chemotherapy or checkpoint inhibitors. Patient must have anti-PD-(L)1 treatment, either alone or in combination, as last treatment before enrollment.
11. Arm L: Ovarian Cancer, ONC-392 monotherapy, will enroll patients with advanced/metastatic ovarian cancer who have progressive disease after prior systemic treatments, including chemotherapy, targeted therapy or checkpoint inhibitors.
12. Arm M: Solid Tumors, ONC-392 monotherapy, will enroll patients with advanced/metastatic solid tumors who are not eligible for Arm A-C or H-L, who have progressive disease after prior systemic treatments, including chemotherapy, targeted therapy or checkpoint inhibitors.
13. Arm N: Renal Cell Carcinoma, ONC-392 monotherapy, will enroll advanced/metastatic RCC patients who are R/R to anti-PD-(L)1 immunotherapy.

(4) Part D is a Phase II study in recurrent and/or metastatic adenoid cystic carcinoma with ONC-392 monotherapy.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 914 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Open label
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)
• Actual Study Start Date: September 16, 2020
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: ONC-392 Treatment as single agent; The Part A study will test ONC-392 intravenous (IV) infusion up to five predefined dose levels from 0.1 mg/kg to 10 mg/kg ONC-392 as monotherapy every 21 days (Q3W). The Part A study will determine the maximal tolerable dose (MTD) and the recommended Phase 2 dose in monotherapy (RP2D-M). In Part C, Arms A-C, I-N monotherapy expansion cohorts will further assess the safety and efficacy of ONC-392 in different dose levels as monotherapy in pancreatic cancer, triple negative breast cancer, non small cell lung cancer with driver mutations, PD-1 resistant non small cell lung cancer, PD-1 resistant melanoma, head and neck cancer, ovarian cancer, renal cell carcinoma and other solid tumors. Part D is a Phase II study on recurrent and/or metastatic adenoid cystic carcinoma.	Drug: ONC-392; ONC-392 will be given by intravenous infusion, once every 21 days (Q3W). In Part C Arm M and in Part D, ONC-392 will be given Q4W.; Other Name: A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc.
Experimental: ONC-392 in combination with pembrolizumab; The Part B1 study will test ONC-392 intravenous (IV) infusion, Q3W, in combination with fixed dose of pembrolizumab. The dose for pembrolizumab will be fixed at 200mg/cycle dosed every 21 days (Q3W). The Part B1 will start at one level below RP2D-M dose for ONC-392 and 200mg of pembrolizumab. When 2 DLTs occur before 6 patients are enrolled, the ONC-392 dose will be decreased to the next dose level until ≤ 1/6 patients treated at that dose develops a DLT. This dose level will be designated RP2D-C. In Part C, the expansion cohorts Arm D to G will assess the safety and efficacy of ONC-392 in different dose levels and Pembrolizumab combination therapy in non small cell lung cancer, and metastatic melanoma.	Drug: ONC-392; ONC-392 will be given by intravenous infusion, once every 21 days (Q3W). In Part C Arm M and in Part D, ONC-392 will be given Q4W.; Other Name: A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc.; Drug: Pembrolizumab; Pembrolizumab will be given intravenous (IV) infusion at 200 mg/cycle, once every 21 days (Q3W).; Other Names: Keytruda; MK3475

Outcome Measures

Primary Outcome Measures :

1. Dose limiting toxicity (DLT) in monotherapy [ Time Frame: 21 days ]
   The number of subjects who have dose limiting toxicity during the first cycle of study drug, ONC-392, administration.
2. Maximal tolerable dose (MTD) in monotherapy [ Time Frame: 21 days ]
   The study drug, ONC-392, dose level that has two out of six subjects who have dose limiting toxicity.
3. Recommended Phase II Dose (RP2D) [ Time Frame: 21 days ]
   The study drug, ONC-392, dose level that is one level below MTD, or an intermediate dose level that below MTD and pre-specified in protocol. This dose level will be the RP2D for monotherapy.
4. Rate of treatment related adverse events (TRAE) according to CTCAE v5.0 [ Time Frame: One year ]
   The safety profile will be presented as tabulated TRAE.

Secondary Outcome Measures :

1. The serum half life of the study drug, ONC-392, in monotherapy. [ Time Frame: 12 weeks ]
   To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life.
2. The serum half life of the study drug, ONC-392, in combination therapy with Pembrolizumab. [ Time Frame: 12 weeks ]
   To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life.
3. Objective Response Rate (ORR) [ Time Frame: 1 year ]
   To determine the objective response rate based on RECIST v1.1.
4. Progression Free Survival (PFS) [ Time Frame: 1 year ]
   To determine the progression free survival based on RECIST 1.1 and iRECIST.
5. Overall Survival (OS) [ Time Frame: 1 year ]
   To determine the overall survival.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. . Patients must have a histological or cytological diagnosis of NSCLC or any other type of carcinoma or sarcomas, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.

   1. In the Part A Phase I dose escalation study of ONC-392 monotherapy, patients with advanced/metastatic solid tumors of any histology are eligible for participation.

      Please note: tumor types of primary interest in this study are malignant melanoma, renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer, head and neck carcinoma, gastric carcinoma, ovarian carcinoma, colorectal cancer, any type of sarcoma.

   2. In Part B dose finding of the ONC-392 plus pembrolizumab combination, patients with advanced/metastatic solid tumors of any histology that Pembrolizumab has been approval as standard of care are eligible for participation.
   3. In Part C, patients with pancreatic cancer, triple negative breast cancer, non small cell lung cancer, melanoma, Head and Neck cancer, ovarian cancer, and other solid tumors are eligible.
   4. In Part D, patients with recurrent and/or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible.
   5. Patients must have RECIST V1.1 Measurable disease:
2. Patient is male or female and >18 years of age on day of signing informed consent.
3. Patient must have a performance status of 0 or 1 on the ECOG Performance Scale

4. Patient must have adequate organ function as indicated by the following laboratory values:

   Hematological: Absolute neutrophil count (ANC) ≥1,500 /mcL; Plateletsa ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications; Renal: Serum creatinine ≤1.5 X upper limit of normal (ULN); Hepatic: Serum total bilirubin ≤1.5 X ULN; OR Direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 ULN; AST (SGOT) and ALT (SGPT) ≤2.5 X ULN, OR ≤5 X ULN for patients with active liver metastases Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN

5. Patient has voluntarily agreed to participate by giving written informed consent.
6. Female patient of childbearing potential has a negative urine or serum pregnancy test.
7. Female and Male patients must agree to use adequate methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy.

Exclusion Criteria:

A patient meeting any of the following criteria is not eligible to participate in this study:

1. Patients who have not recovered to CTCAE ≤ 1 from the AE due to cancer therapeutics. The washout period for cancer therapeutic drugs (such as chemotherapy, radioactive, or targeted therapy) is 21 days, and for antibody drug 28 days.
2. Patients who are currently enrolled in a clinical trial of an investigational agent or device.
3. Patients who are on chronic systemic steroid therapy at doses >10 mg/day
4. Patients who have active symptomatic brain metastasis or leptomeningeal metastasis.
5. Patients who have an active infection requiring systemic IV therapy within 14 days of prior to administration of ONC-392 or combined ONC-392 and Pembrolizumab.
6. Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
7. Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
8. Patients who are pregnant or breastfeeding.
9. For the Part B and Part C Arm D to G, the patients that are deemed to be not suitable for Pembrolizumab.

Contacts and Locations

Contacts

Contact: Pan Zheng, MD, PhD; 202 751 6823; pzheng@oncoc4.com

Contact: Martin Devenport, PhD; 4102070582; mdevenport@oncoc4.com

Locations

United States, Arkansas

Highlands Oncology Group; Recruiting

Springdale, Arkansas, United States, 72762

Principal Investigator: Eric Schaefer

United States, California

University of California at Davis; Recruiting

Davis, California, United States, 95817

Principal Investigator: Tianhong Li, MD, PhD

The Oncology Institute of Hope and Innovation; Recruiting

Downey, California, United States, 90241

Principal Investigator: Richy Agajanian, MD

City of Hope Cancer Center; Recruiting

Duarte, California, United States, 91010

Principal Investigator: Lorna Rodriguez, MD

United States, Colorado

University of Colorado Hospital; Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator: Daniel Bowles, MD

United States, Connecticut

University of Connecticut Medical Center; Recruiting

Farmington, Connecticut, United States, 06030

Principal Investigator: Susan Tannenbaum, MD

Nuvance Health; Recruiting

Norwalk, Connecticut, United States, 06856

Principal Investigator: Richard Frank, MD

United States, District of Columbia

MedStar Georgetown University Hospital; Recruiting

Washington, District of Columbia, United States, 20007

Principal Investigator: Aiwu He, MD, PhD

United States, Florida

Florida Cancer Specialists; Recruiting

Atlantis, Florida, United States, 33462

Principal Investigator: Shaachi Gupta, MD

University of Florida Health Cancer Center; Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: Thomas George, MD

Ocala Oncology Florida Cancer Affiliates; Recruiting

Ocala, Florida, United States, 34474

Principal Investigator: Rama Balaraman, MD

AdventHealth Cancer Institute; Recruiting

Orlando, Florida, United States, 32804

Principal Investigator: Mark Socinski, MD

Memorial Cancer Institute; Recruiting

Pembroke Pines, Florida, United States, 33028

Principal Investigator: Adriana Milillo-Naraine, MD

United States, Georgia

Emory University Winship Cancer Institute; Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator: Nicole C Schmitt, MD

Principal Investigator: Nabil F Saba, MD

United States, Kentucky

Norton Health; Recruiting

Lexington, Kentucky, United States, 40202

Principal Investigator: John Hamm, MD

United States, Maryland

Greater Baltimore Medical Center; Recruiting

Baltimore, Maryland, United States, 21204

Principal Investigator: Mei Tang, MD, PhD

The Center for Cancer and Blood Disorders; Recruiting

Bethesda, Maryland, United States, 20817

Principal Investigator: Mark Goldstein, MD

United States, Massachusetts

Dana Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator: Glenn Hanna, MD

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator: Colin Weekes, MD

United States, Michigan

University of Michigan Medical Center; Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator: Ulka Vaishampayan, MD

United States, New Jersey

Atlantic Healthcare System; Recruiting

Morristown, New Jersey, United States, 07960

Principal Investigator: Eric Whitman, MD

United States, New York

Memorial Sloan Kettering Cancer Center; Recruiting

New York, New York, United States, 10065

Principal Investigator: Kenneth Yu, MD

Principal Investigator: Eileen O'Reilly, MD

United States, Ohio

University of Cincinnati Medical Center; Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator: Amanda Jackson, MD

The Ohio State University James Cancer Center; Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator: Kai He, MD, PhD

Zangmeister Cancer Center; Recruiting

Columbus, Ohio, United States, 43219

Principal Investigator: Sameh Mikhail, MD

United States, Pennsylvania

Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center); Recruiting

Gettysburg, Pennsylvania, United States, 17325

Principal Investigator: Satish Shah, MD

Penn State Cancer Institute; Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator: Patrick Ma, MD

United States, South Carolina

Prisma Health; Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator: Ki Young Chung, MD

United States, Tennessee

Tennessee Oncology Chattanooga Memorial Plaza; Recruiting

Chattanooga, Tennessee, United States, 37404

Principal Investigator: Edward Arrowsmith, MD

Tennessee Oncology - Nashville; Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator: Meredith McKean, MD

United States, Texas

Houston Methodist Cancer Center; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Jenny Chang, MD

Oncology Consultants; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Julio Peguero, MD

United States, Utah

University of Utah Huntsman Cancer Institute; Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator: Siwen Hu-Lieskovan, MD, PhD

United States, Virginia

NEXT/Virginia Cancer Specialists; Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator: Alexander Spira, MD

United States, Washington

University of Washington / Fred Hutchinson Cancer Center; Recruiting

Seattle, Washington, United States, 98109

Principal Investigator: Cristina P Rodriguez, MD

Australia, New South Wales

Newcastle Private Hospital; Recruiting

New Lambton Heights, New South Wales, Australia, 2305

Principal Investigator: Hiren Mandaliya, MD

Australia, Queensland

Tasman Oncology Research; Recruiting

Southport, Queensland, Australia, 4120

Principal Investigator: Andrew Hill, MD

Australia, South Australia

Cancer Research SA; Recruiting

Adelaide, South Australia, Australia, 5000

Principal Investigator: Rohit Joshi, MD

Southern Oncology Clinical Research Unit; Recruiting

Bedford Park, South Australia, Australia, 5042

Principal Investigator: Ganessan Kitchenadasse, MD

Sponsors and Collaborators

OncoC4, Inc.

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Tianhong Li, MD; University of California, Davis

More Information

Publications:

Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.

Du X, Tang F, Liu M, Su J, Zhang Y, Wu W, Devenport M, Lazarski CA, Zhang P, Wang X, Ye P, Wang C, Hwang E, Zhu T, Xu T, Zheng P, Liu Y. A reappraisal of CTLA-4 checkpoint blockade in cancer immunotherapy. Cell Res. 2018 Apr;28(4):416-432. doi: 10.1038/s41422-018-0011-0. Epub 2018 Feb 22.

Du X, Liu M, Su J, Zhang P, Tang F, Ye P, Devenport M, Wang X, Zhang Y, Liu Y, Zheng P. Uncoupling therapeutic from immunotherapy-related adverse effects for safer and effective anti-CTLA-4 antibodies in CTLA4 humanized mice. Cell Res. 2018 Apr;28(4):433-447. doi: 10.1038/s41422-018-0012-z. Epub 2018 Feb 20.

May KF Jr, Roychowdhury S, Bhatt D, Kocak E, Bai XF, Liu JQ, Ferketich AK, Martin EW Jr, Caligiuri MA, Zheng P, Liu Y. Anti-human CTLA-4 monoclonal antibody promotes T-cell expansion and immunity in a hu-PBL-SCID model: a new method for preclinical screening of costimulatory monoclonal antibodies. Blood. 2005 Feb 1;105(3):1114-20. doi: 10.1182/blood-2004-07-2561. Epub 2004 Oct 14.

Lute KD, May KF Jr, Lu P, Zhang H, Kocak E, Mosinger B, Wolford C, Phillips G, Caligiuri MA, Zheng P, Liu Y. Human CTLA4 knock-in mice unravel the quantitative link between tumor immunity and autoimmunity induced by anti-CTLA-4 antibodies. Blood. 2005 Nov 1;106(9):3127-33. doi: 10.1182/blood-2005-06-2298. Epub 2005 Jul 21.

Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.

• Responsible Party: OncoC4, Inc.
• ClinicalTrials.gov Identifier: NCT04140526
• Other Study ID Numbers: ONC-392-001; 4R44CA250824-02 ( U.S. NIH Grant/Contract ); 20193108 ( Other Identifier: WIRB )
• First Posted: October 28, 2019
• Last Update Posted: March 20, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma; Lung Neoplasms; Small Cell Lung Carcinoma; Salivary Gland Neoplasms; Pancreatic Neoplasms; Carcinoma, Adenoid Cystic; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Adenocarcinoma; Endocrine Gland Neoplasms; Endocrine System Diseases; Head and Neck Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Pancreatic Diseases; Pembrolizumab; Antineoplastic Agents, Immunological; Antineoplastic Agents