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INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580485
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

Condition or disease Intervention/treatment Phase
Ovarian Cancer Bladder Cancer Non Small Cell Lung Cancer Squamous Cell Carcinoma of Head and Neck Triple Negative Breast Cancer Castration Resistant Prostate Cancer Colorectal Cancer Gastric/ Gastroesophageal Junction Hepatocellular Carcinoma Pancreatic Ductal Adenocarcinoma Squamous Carcinoma of the Anal Canal Drug: INCB106385 Drug: INCMGA00012 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : April 10, 2024
Estimated Study Completion Date : April 10, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group A (TGA) - INCB106385

In part 1 dose escalation, the dose levels will be escalated following a BOIN design.

In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.

Drug: INCB106385
INCB106385 will be administered orally QD

Experimental: Treatment Group B (TGB) - INCB106385+INCMGA00012

In part 1 dose escalation, the dose levels will be escalated following a BOIN design.

In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE.

Drug: INCB106385
INCB106385 will be administered orally QD

Drug: INCMGA00012
INCMGA0012 will be administered IV once every 4 weeks (Q4W)




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAE) [ Time Frame: Up to Approximately 28 months ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.


Secondary Outcome Measures :
  1. Cmax of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ]
    Maximum observed plasma concentration.

  2. Tmax of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ]
    Time to maximum plasma concentration

  3. Cmin of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ]
    Minimum observed plasma concentration over the dose interval

  4. AUC of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ]
    Area under the plasma concentration-time curve

  5. CL/F of INCB106385 as a single agent or in combination with INCMGA00012 [ Time Frame: Up to 6 months ]
    Apparent oral dose clearance

  6. Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]
    Defined as the percentage of participants with a best overall response of CR or PR, as determined by investigator radiographic disease assessment according to RECIST v1.1.

  7. Disease Control Rate [ Time Frame: Up to approximately 24 months ]
    Defined as the percentage of participants with a best overall response of CR, PR, or SD, as determined by investigator radiographic disease assessment according to RECIST v1.1.

  8. Duration Of Response (DOR) [ Time Frame: Up to approximately 24 months ]
    Defined as the time from the earliest date of CR or PR until the earliest date of disease progression, as determined by investigator radiographic disease assessment according to RECIST v1.1, or death due to any cause if occurring sooner than progression.

  9. Change in tumoral gene expression [ Time Frame: Predose and Week 5-6 ]
    Defined as the percent of patients with change in tumoral targeted gene expression compared to baseline

  10. Change in immune cell activation in tumors [ Time Frame: Predose and Week 5-6 ]
    Defined as the percent of patients demonstrating change in immune cell activation in tumors compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Inclusion Criteria:

  • Ability to comprehend and willingness to sign an ICF.
  • Willing and able to conform to and comply with all Protocol requirements.
  • Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable).
  • Willingness to undergo pre- and on-treatment tumor biopsy.
  • Have CD8 T-cell-positive tumors.
  • Presence of measurable disease according to RECIST v1.1.
  • ECOG performance status 0 to 1.
  • Life expectancy > 12 weeks.
  • Willingness to avoid pregnancy or fathering children based.
  • Acceptable laboratory parameters

Exclusion Criteria:

  • Clinically significant cardiac disease.
  • Known or active CNS metastases and/or carcinomatous meningitis.
  • Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease..
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
  • Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment.
  • Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
  • Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.
  • Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage.
  • Any prior chemotherapy, biological therapy, or targeted therapy to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
  • Any prior radiation therapy within 28 days before the first dose of study treatment.
  • Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
  • Concomitant treatment with strong CYP3A4 inhibitors or inducers.
  • Receipt of a live vaccine within 30 days of the first dose of study treatment.
  • Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment.
  • Evidence of HBV or HCV infection or risk of reactivation.
  • Known history of HIV (HIV 1/2 antibodies).
  • History of organ transplant, including allogeneic stem-cell transplantation.
  • Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components.
  • Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data

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): NCT04580485


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Ilona Rybicka, M.D Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04580485    
Other Study ID Numbers: INCB 106385-102
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
INCB106385
Advanced Solid Tumors
PD-1
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Breast Neoplasms
Breast Diseases
Skin Diseases
Head and Neck Neoplasms