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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests JNJ-89402638 for colon, rectal, or stomach cancer that has spread. It aims to find doses for future studies, the best way to give the drug, and how safe it is. For colon or rectal cancer, it also tests the drug with bevacizumab or a very similar drug, with or without chemotherapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Part 1 and Part 2 Arms A and B: Tests of tissue or cells must confirm colon or rectal cancer. The cancer must have worsened after at least 2 rounds of standard treatment plans for cancer that has spread or cannot be removed by surgery.
  • Part 2 Arm C: Have confirmed colon or rectal cancer with MSS or pMMR test results, which describe how cancer cells repair DNA. Cancer must have worsened after at least 1 standard treatment plan for spread or cancer that cannot be removed. Past treatment must include a fluoropyrimidine drug plus irinotecan, such as FOLFIRI.
  • Part 2 Arm D: Have confirmed colon or rectal cancer with MSS or pMMR test results. Cancer must have worsened after 1 standard treatment plan for spread or cancer that cannot be removed. You must not have had irinotecan for cancer that has spread.
  • Part 2 Arm E: Tests must confirm cancer in the stomach or where the food pipe meets the stomach. Cancer must have worsened after at least 1 standard treatment plan for spread or cancer that cannot be removed by surgery.
  • Part 1: Have cancer that can be measured or checked. Part 2: Have at least 1 tumor that can be measured.
  • Be fully active, or able to walk and do light work even if hard physical activity is limited.
  • Have a kidney filtering rate, called GFR, of at least 30 mL per minute.

Who can't join

  • Have new or growing cancer in the brain, cancer in the tissues around the brain and spinal cord, or untreated pressure on the spinal cord.
  • Still have side effects from past cancer treatment that are more than mild. Exceptions include hair loss, loss of skin color, certain nerve damage, or hormone problems stable with hormone replacement. Arm C does not allow moderate or worse nerve damage.
  • Have another past or current cancer, unless its course or treatment is unlikely to affect the study’s safety or treatment results.
  • Have taken steroid medicine at a dose above 10 mg of prednisone per day, or an equal dose of another steroid, within 7 days before the first study dose.
  • Have received or plan to receive a live, weakened vaccine from 4 weeks before the first study dose through 4 weeks after the last study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 1. Part 1: Must have either measurable or evaluable disease 2. 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

Study sites (6)

AZ

CO

FL

IN

MI

WA