A Study of JNJ-89402638 for Metastatic Colorectal Cancer
- Registration Number
- NCT06663319
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) of JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
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Have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma (CRC) progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting
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Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1
- Part 1: Must have either measurable or evaluable disease
- Part 2: Must have at least 1 measurable lesion
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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Have an estimated or measured glomerular filtration rate (GFR) greater than or equal to (>=) 30 milliliter per minute (mL/min) based on modification of diet in renal disease (MDRD) 4-variable formula
- Active (new or progressive) brain metastases, leptomeningeal disease, or untreated spinal cord compression
- Toxicity from prior anticancer therapy that has not resolved to Grade less than or equal to (<=)1 (except alopecia, vitiligo, Grade <= 2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)
- Has a prior or concurrent second malignancy (other than the disease under study) unless natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
- Received glucocorticoids (doses >10 mg/day prednisone or equivalent) within 7 days prior to the first dose of study drug
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment or within 4 weeks after the last dose of study treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JNJ-89402638 JNJ-89402638 Participants with unresectable metastatic colorectal adenocarcinoma (mCRC) will receive JNJ-89402638 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially until the recommended Phase 2 Dose(s) (RP2D) have been identified. Participants in Part 2 (Dose expansion) will receive JNJ-89402638 at the RP2D(s) determined in Part 1.
- Primary Outcome Measures
Name Time Method Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity From Baseline up to approximately 24 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) From Baseline up to 28 days The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.
- Secondary Outcome Measures
Name Time Method Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638 Up to approximately 24 months Cmin of JNJ-89402638 will be reported.
Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638 Up to approximately 24 months Tmax of JNJ-89402638 will be reported.
Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638 Up to approximately 24 months AUC of JNJ-89402638 will be reported.
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies Up to approximately 24 months Participants with anti-JNJ-89402638 antibodies will be reported.
Part 1 and Part 2: Serum Concentration for JNJ-89402638 Up to approximately 24 months Serum Concentration for JNJ-89402638 will be reported.
Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638 Up to approximately 24 months Cmax of JNJ-89402638 will be reported.
Part 1 and Part 2: Overall Response (OR) Up to approximately 24 months Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1.
Part 1 and Part 2: Complete Response (CR) Up to approximately 24 months Complete response is defined as a best response of CR assessed according to RECIST version 1.1.
Part 1 and Part 2: Time to Response (TTR) Up to approximately 24 months TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1.
Part 1 and Part 2: Duration of Response (DOR) Up to approximately 24 months DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1
Trial Locations
- Locations (8)
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
University of Colorado Denver Anschultz Medical Campus
🇺🇸Aurora, Colorado, United States
Florida Cancer Specialists
🇺🇸Sarasota, Florida, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Start Midwest
🇺🇸Grand Rapids, Michigan, United States
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hosp Univ Hm Sanchinarro
🇪🇸Madrid, Spain