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NCT Number: NCT06663319

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

The 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For Part 1 (dose escalation), Part 2 (Arm A [JNJ-89402638 monotherapy]): 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; For Part 2 Arm B (JNJ-89402638 + bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of CRC progressing after 2 or more prior lines of standard therapy in the metastatic/unresectable setting; For Part 2 Arm C (JNJ-89402638 + FOLFOX/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of microsatellite stable (MSS) or proficient mismatch repair (pMMR) CRC progressing after 1 or more prior lines of standard therapy in the metastatic/unresectable setting. Participants must have previously received a fluoropyrimidine and irinotecan doublet (such as FOLFIRI); For Part 2 Arm D (JNJ-89402638 + FOLFIRI/bevacizumab or biosimilar): Have histologically or cytologically confirmed diagnosis of MSS or pMMR CRC progressing after 1 prior line of standard therapy in the metastatic/unresectable setting. Must not have received irinotecan previously for metastatic disease; For Part 2 Arm E (JNJ-89402638 monotherapy in mGAC): Have histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressing after 1 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
  • Part 1: Must have either measurable or evaluable disease
  • 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). For Part 2 Arm C: Grade 2 or higher peripheral neuropathy is considered exclusionary
  • 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

Treatment and study plan

JNJ-89402638

Drug

JNJ-89402638 will be administered.

Bevacizumab

Drug

Bevacizumab or biosimilar will be administered.

FOLFOX

Drug

Chemotherapy agent FOLFOX will be administered.

FOLFIRI

Drug

Chemotherapy agent FOLFIRI will be administered.

Primary outcomes

  1. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

    Time frame: From Baseline up to approximately 24 months

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus.

  2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

    Time frame: From Baseline up to 28 days

    The DLTs are specific adverse events including high grade hematologic or non-hematologic toxicities.

Secondary outcomes

  1. Part 1 and Part 2: Serum Concentration for JNJ-89402638

    Time frame: Up to approximately 24 months

    Serum Concentration for JNJ-89402638 will be reported.

  2. Part 1 and Part 2: Maximum Serum Concentration (Cmax) of JNJ-89402638

    Time frame: Up to approximately 24 months

    Cmax of JNJ-89402638 will be reported.

  3. Part 1 and Part 2: Minimum Serum Concentration (Cmin) of JNJ-89402638

    Time frame: Up to approximately 24 months

    Cmin of JNJ-89402638 will be reported.

  4. Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-89402638

    Time frame: Up to approximately 24 months

    Tmax of JNJ-89402638 will be reported.

  5. Part 1 and Part 2: Area Under the Serum Concentration-time Curve (AUC) of JNJ-89402638

    Time frame: Up to approximately 24 months

    AUC of JNJ-89402638 will be reported.

  6. Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-89402638 Antibodies

    Time frame: Up to approximately 24 months

    Participants with anti-JNJ-89402638 antibodies will be reported.

  7. Part 1 and Part 2: Overall Response (OR)

    Time frame: Up to approximately 24 months

    Overall response is best response of complete response (CR) or partial response (PR), assessed according to response evaluation criteria in solid tumors (RECIST) version 1.1.

  8. Part 1 and Part 2: Complete Response (CR)

    Time frame: Up to approximately 24 months

    Complete response is defined as a best response of CR assessed according to RECIST version 1.1.

  9. Part 1 and Part 2: Time to Response (TTR)

    Time frame: Up to approximately 24 months

    TTR is defined for participants who achieved an OR from the time of the first dose of study treatment to the first response of PR or better as assessed according to RECIST version 1.1.

  10. Part 1 and Part 2: Duration of Response (DOR)

    Time frame: Up to approximately 24 months

    DOR is defined for participants who achieved an OR in the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death due to any cause, whichever occurs first, as assessed according to RECIST version 1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 29, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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