Health TrialsbyHealthPanel

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

ConditionsColorectal NeoplasmsGastrointestinal Neoplasms
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

260 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part 1 (Dose Expansion)Experimental treatment 1 intervention
Group B: Part 2 (Dose Expansion): Arm AExperimental treatment 1 intervention
Group C: Part 2 (Dose Expansion): Arm BExperimental treatment 2 interventions
Group D: Part 2 (Dose Expansion): Arm CExperimental treatment 3 interventions
Group E: Part 2 (Dose Expansion): Arm DExperimental treatment 3 interventions
Group F: Part 2 (Dose Expansion): Arm EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
From Baseline up to approximately 24 months
2

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

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

Time frame
From Baseline up to 28 days

Secondary outcomes

1

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

Serum Concentration for JNJ-89402638 will be reported.

Time frame
Up to approximately 24 months
2

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

Cmax of JNJ-89402638 will be reported.

Time frame
Up to approximately 24 months
3

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

Cmin of JNJ-89402638 will be reported.

Time frame
Up to approximately 24 months
4

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

Tmax of JNJ-89402638 will be reported.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
Apply now