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Recruiting NCT06764771

A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Phase I Interventional Advanced Malignant Tumors

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986488, Adagrasib, Cetuximab, Nivolumab.
Who it may be relevant to
Registry conditions: Advanced Malignant Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Overview

This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.

Interventions

  • Drug BMS-986488
    Specified dose on specified days
  • Drug Adagrasib
    Specified dose on specified days
  • Drug Cetuximab
    Specified dose on specified days
  • Drug Nivolumab
    Specified dose on specified days

Primary outcome measures

  • Number of participants with Adverse Events (AEs) [Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)]
  • Number of participants with Serious AEs (SAEs) [Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)]
  • Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria [Time frame: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)]
  • Number of participants with AEs leading to discontinuation [Time frame: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)]
  • Number of deaths [Time frame: From time of informed consent up to 52 weeks after end of treatment visit]
Secondary outcome measures (6)
  • Maximum observed plasma concentration (Cmax) [Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)]
  • Time of maximum observed concentration (Tmax) [Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)]
  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [Time frame: Until Cycle 4, Day 1 (1 Cycle = 28 Days)]
  • Objective response rate (ORR) [Time frame: From time of informed consent up to 52 weeks after end of treatment visit]
  • Disease control rate (DCR) [Time frame: From time of informed consent up to 52 weeks after end of treatment visit]
  • Duration of response (DOR) [Time frame: From time of informed consent up to 52 weeks after end of treatment visit]

Eligibility criteria

Inclusion criteria

  • Participant must be ≥ 18 years of age.
  • Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
  • Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
  • Parts 2A, 1D, 2D: ccRCC.

i) Part 1B: solid tumors with KRAS G12C mutation.

ii) Part 2B: NSCLC with KRAS G12C mutation.

iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.

  • Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
  • Participants must have measurable disease per RECIST v1.1.

Exclusion criteria

  • Untreated central nervous system (CNS) metastases.
  • Leptomeningeal metastasis (carcinomatous meningitis).
  • Impaired cardiac function or clinically significant cardiac disease.
  • For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.

i) History of pneumonitis or interstitial lung disease (ILD).

ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

\- Other protocol-defined inclusion/exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • John Theurer Cancer Center at Hackensack University Medical Center — Hackensack
  • Local Institution - 0020 — Allentown
  • The West Clinic, PLLC dba West Cancer Center — Germantown
  • Local Institution - 0025 — Dallas
Canada · 3 centers
  • BC Cancer Vancouver — Vancouver
  • Local Institution - 0015 — Montreal
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésu — Québec
Australia · 1 center
  • Local Institution - 0031 — Brisbane

Identifiers

NCT: NCT06764771 · CA234-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗