OncoMatch

OncoMatch/Clinical Trials/NCT06663319

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

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

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

Treatment: JNJ-89402638 · Bevacizumab · FOLFOX · FOLFIRIThe 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 (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: MSH2 proficient mismatch repair

microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC

Required: MSH6 proficient mismatch repair

microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC

Required: MLH1 proficient mismatch repair

microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC

Required: PMS2 proficient mismatch repair

microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard therapy — metastatic/unresectable

progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting

Must have received: standard therapy — metastatic/unresectable

progressing after 1 prior line of standard therapy in the metastatic/unresectable setting

Cannot have received: platinum-based chemotherapy (oxaliplatin)

Exception: must not have received oxaliplatin previously for metastatic disease (Part 2 Arm C)

Must not have received oxaliplatin previously for metastatic disease

Cannot have received: topoisomerase inhibitor (irinotecan)

Exception: must not have received irinotecan previously for metastatic disease (Part 2 Arm D)

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 platinum-based chemotherapy, topoisomerase inhibitor disqualifies patients from enrollment.

Does this trial require MSH2?

Yes, MSH2 proficient mismatch repair is a required biomarker for enrollment.

Does this trial require MSH6?

Yes, MSH6 proficient mismatch repair is a required biomarker for enrollment.

Does this trial require MLH1?

Yes, MLH1 proficient mismatch repair 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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