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OncoMatch/Clinical Trials/NCT06663319

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

Is NCT06663319 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including JNJ-89402638 and Bevacizumab for colorectal neoplasms.

Phase 1RecruitingJanssen Research & Development, LLCNCT06663319Data as of Sep 2026Location: United States · South Korea · Spain

Treatment: JNJ-89402638 · Bevacizumab · FOLFOX · FOLFIRIThe purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) and best way to take (optimal route of administration) JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Bevacizumab

Other

JNJ-89402638FOLFOXFOLFIRI

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MLH1 wild-type

Required: MLH1 wild-type

Required: MSH2 wild-type

Required: MSH2 wild-type

Required: MSH6 wild-type

Required: MSH6 wild-type

Required: PMS2 wild-type

Required: PMS2 wild-type

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: fluoropyrimidine and irinotecan doublet (FOLFIRI) — metastatic/unresectable CRC

Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI)

Cannot have received: irinotecan for metastatic disease (irinotecan)

Must not have received irinotecan previously for metastatic disease

Lab requirements

Kidney function

gfr >= 30 ml/min based on mdrd 4-variable formula

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Colorado Denver Anschultz Medical Campus · Aurora, Colorado
  • Florida Cancer Specialists · Sarasota, Florida
  • Community Health Network · Indianapolis, Indiana
  • Start Midwest · Grand Rapids, Michigan
  • Swedish Cancer Institute · Seattle, Washington

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06663319 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior irinotecan for metastatic disease disqualifies patients from enrollment.

Does this trial require MLH1?

Yes, MLH1 wild-type is a required biomarker for enrollment.

Does this trial require MLH1?

Yes, MLH1 wild-type is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 wild-type is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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