89402638GIC1001
Colorectal cancer
A Phase 1 study to determine the RP2D(s) of JNJ-89402638 and to determine the
safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer
Phase
Compound
JNJ-89402638 (GUCY2C × CD3)
NCT identifier
NCT06663319
Enrollment
N=~220
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Histologically or cytologically confirmed metastatic or unresectable CRC
- ≥2 prior lines of standard therapy
- Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST v1.1)
- Part 1: must have measurable or evaluable disease
- Part 2: must have ≥1 measurable lesion
- ECOG PS 0 or 1
Study
design
Primary outcomes:
- DLT (Part 1)
- AEs (Parts 1 and 2)
Secondary outcomes:
- Serum concentration for JNJ-89402638
- Cmax
- Cmin
- Tmax
- AUC
- ADAs
- Overall response
- CR
- TTR
- DOR
*Not a complete list of inclusion and exclusion criteria.
ADA, antibody-drug conjugate; AE, adverse event; AUC, area under the serum concentration-time curve; Cmax, maximum serum concentration; Cmin, minimum serum concentration; CR, complete response, CRC, colorectal cancer; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; RECIST, Response Evaluation Criteria in Solid Tumors; RP2D, recommended Phase 2 dose; Tmax, time to reach maximum observed serum concentration; TTR, time to response.