Clinical trial NCT06663319: A Study of JNJ-89402638 for Metastatic Colorectal Cancer
Official title: A Phase I Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Unresectable Metastatic Colorectal Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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
* Have evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1

  1. Part 1: Must have either measurable or evaluable disease
  2. Part 2: Must have at least 1 measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: From Baseline up to approximately 24 months
measure: Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
timeFrame: From Baseline up to 28 days
Secondary outcomes:
measure: Part 1 and Part 2: Serum Concentration for JNJ-89402638
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Overall Response (OR)
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Complete Response (CR)
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Time to Response (TTR)
timeFrame: Up to approximately 24 months
measure: Part 1 and Part 2: Duration of Response (DOR)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver Anschultz Medical Campus
state: Colorado
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Grand Rapids
country: United States
facility: Start Midwest
state: Michigan
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: