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

NCT06663319
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
260
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2024-10-15
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Number of sites
12
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Summary
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.
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Short title
A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
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Official title
A Phase 1 Study of JNJ-89402638 for Unresectable Metastatic Colorectal Cancer and Other Gastrointestinal Malignancies
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-07-19
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First posted
2024-10-29
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Registry last updated
2026-08-28
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Primary completion date
2028-02-25
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Start date
2024-10-15
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Participants
260
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Participant count basis
Estimated
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Planned participants
260
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Protocol amendments
4
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Number of sites
12
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06663319
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ClinicalTrials.gov ID
NCT06663319
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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)

    Timeframe: From Baseline up to 28 days

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

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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Up to approximately 24 months

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

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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • University of Arizona Cancer CenterTucson, United StatesRecruiting
  • University of Colorado Denver Anschultz Medical CampusAurora, United StatesRecruiting
  • Florida Cancer SpecialistsSarasota, United StatesRecruiting
  • Community Health NetworkIndianapolis, United StatesRecruiting
  • Start MidwestGrand Rapids, United StatesRecruiting
  • Swedish Cancer InstituteSeattle, United StatesRecruiting
  • Severance Hospital Yonsei University Health SystemSeoul, South KoreaRecruiting
  • Asan Medical CenterSeoul, South KoreaRecruiting
  • Hosp Univ Vall D HebronBarcelona, SpainRecruiting
  • Hosp Univ Fund Jimenez DiazMadrid, SpainRecruiting
  • Hosp. Univ. 12 de OctubreMadrid, SpainRecruiting
  • Hosp Univ Hm SanchinarroMadrid, SpainRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-516526-66-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (1)