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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • JNJ-89402638
  • Bevacizumab
  • FOLFOX
  • FOLFIRI

Treatment groups

260 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.