N=~220
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Key eligibility criteria*:
- Part 1 and Part 2 (Arm A): CRC after ≥2 prior lines of standard therapy in metastatic/unresectable setting
- Part 2 (Arm B): CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting
- Part 2 (Arm C): MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting
- Part 2 (Arm D): MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting
- Part 2 (Arm E): gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting
- Evaluable or measurable disease per RECIST v1.1
- Part 1: must have measurable or evaluable disease
- Part 2: must have ≥1 measurable lesion
- ECOG PS 0 or 1
Primary outcomes:
- DLT (Part 1)
- AEs by severity (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. †Participants with mCRC. ‡Participants with mGAC.
ADA, antidrug antibody; 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; FOLFIRI; 5-fluorouracil, leucovorin, and irinotecan; FOLFOX, 5-fluorouracil, leucovorin, and oxaliplatin; mCRC, metastatic colorectal cancer; mGAC, metastatic gastric cancer; MSS, microsatellite stable; pMMR, proficient mismatch repair; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; RP2D, recommended Phase 2 dose; Tmax, time to reach maximum observed serum concentration; TTR, time to response.