A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
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| ClinicalTrials.gov Identifier: NCT04440943 |
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Recruitment Status :
Recruiting
First Posted : June 22, 2020
Last Update Posted : March 2, 2022
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Sponsor:
Celldex Therapeutics
Information provided by (Responsible Party):
Celldex Therapeutics
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Brief Summary:
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer Breast Cancer Gastric Cancer Renal Cell Carcinoma Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Cholangiocarcinoma Bladder Urothelial Carcinoma MSI-H Colorectal Cancer Esophageal Cancer Hepatic Cancer Head and Neck Cancer Other Solid Tumors | Drug: CDX-527 | Phase 1 |
This study will determine the safety, tolerability and activity of CDX-527.
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-527. The dose-escalation part of the study will determine the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the expansion part of the study.
The expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation
Up to 40 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies |
| Actual Study Start Date : | August 4, 2020 |
| Estimated Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | March 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cholangiocarcinoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: CDX-527
Dose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance. Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase. |
Drug: CDX-527
CDX-527 is administered by infusion every 2 weeks |
Primary Outcome Measures :
- Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0 [ Time Frame: From first dose through 28 days after last dose ]The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
Secondary Outcome Measures :
- Objective Response Rate [ Time Frame: Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years. ]The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
- Clinical Benefit Rate [ Time Frame: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years. ]The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
- Duration of Response [ Time Frame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years) ]The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
- Progression-free Survival [ Time Frame: From the first dose to the first occurrence of disease progression or death due to any cause (up to approximately 1-2 years) ]The time from start of study drug to time of progression or death, whichever occurs first
- Overall Survival [ Time Frame: The time from start of study drug to death from any cause (up to approximately 1-2 years) ]The time from start of study drug to death
- Immunogenicity Evaluation [ Time Frame: Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose ]Serum samples will be obtained for assessment of human anti-CDX-527 antibodies
- Pharmacokinetic Evaluation [ Time Frame: Before and after dosing, with additional timepoints after the first two doses, then intermittently before dosing and up to 60 days after the last dose ]CDX-527 serum concentrations will be measured at specified visits.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma.
- Receipt of all standard therapies for the tumor type
- Measurable (target) disease by iRECIST
- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment
- Willingness to undergo a pre-treatment and on-treatment biopsy, if required
Key Exclusion Criteria:
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Previous treatment with any anti-CD27 antibody.
- Inadequate washout period from prior therapy as defined in the Protocol.
- Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on their tumor type
- Major surgery within 4 weeks prior to study treatment.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll.
- Thrombotic events within the last 6 months prior to study treatment
- Active, untreated central nervous system metastases.
- Active autoimmune disease or documented history of autoimmune disease.
- History of (non-infectious) pneumonitis or has current pneumonitis.
- Active diverticulitis
- Known infection of HIV, Hepatitis B, or Hepatitis C.
There are additional criteria your study doctor will review with you to confirm your eligibility for the study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440943
Contacts
| Contact: Celldex Therapeutics | (844) 723-9363 | info@celldex.com |
Locations
| United States, Georgia | |
| Northside Hospital | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Anila Lokhandwala 404-236-8124 | |
| Principal Investigator: Rodolfo Bordoni, MD | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Eli Gussen | |
| Contact gussene@medicine.bsd.uchicago.edu | |
| Principal Investigator: Gini Fleming, MD | |
| United States, Nebraska | |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Recruiting |
| Omaha, Nebraska, United States, 68130 | |
| Contact: Scott Degenhardt sdegenhardt@nebraskacancer.com | |
| Principal Investigator: Ralph Hauke, MD | |
| United States, North Carolina | |
| Duke Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Duke Center for Cancer Immunotherapy Clinical Trials Office 919-681-6468 CCI-ImmunoOnc@duke.edu | |
| Principal Investigator: Mustafa Khasraw, MD | |
| United States, Oregon | |
| Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: Christina Lopez 503-215-2614 CanRsrchStudies@providence.org | |
| Principal Investigator: Rachel Sanborn, MD | |
Sponsors and Collaborators
Celldex Therapeutics
| Responsible Party: | Celldex Therapeutics |
| ClinicalTrials.gov Identifier: | NCT04440943 |
| Other Study ID Numbers: |
CDX527-01 |
| First Posted: | June 22, 2020 Key Record Dates |
| Last Update Posted: | March 2, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Renal Cell Cholangiocarcinoma Fallopian Tube Neoplasms Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases |
Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Kidney Diseases Urologic Diseases Fallopian Tube Diseases Liver Diseases |