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Recruiting NCT07223047

A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

Phase I / Phase II Interventional Advanced Solid Malignancies Non-small Cell Lung Cancer (NSCLC) Colorectal Cancer (CRC) Pancreatic Ductal Adenocarcinoma (PDAC)

For patients and families

In plain language

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-986523, Gemcitabine, Nab-Paclitaxel, Cetuximab.
Who it may be relevant to
Registry conditions: Advanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC). 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, Canada, Spain
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 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

Overview

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Interventions

  • Drug BMS-986523
    Specified dose on specified days
  • Drug Gemcitabine
    Specified dose on specified days
  • Drug Nab-Paclitaxel
    Specified dose on specified days
  • Drug Cetuximab
    Specified dose on specified days
  • Drug Pembrolizumab
    Specified dose on specified days

Primary outcome measures

  • Number of participants with adverse events (AEs) [Time frame: Up to 3 years]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to 3 years]
  • Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria [Time frame: Up to 3 years]
  • Number of participants with AEs leading to discontinuation [Time frame: Up to 3 years]
  • Number of deaths [Time frame: Up to 3 years]
Secondary outcome measures (5)
  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator. [Time frame: Up to 3 years]
  • Duration of response (DOR) per RECIST v1.1 as assessed by the investigator. [Time frame: Up to 3 years]
  • Maximum observed plasma concentration (Cmax) [Time frame: Up to 3 years]
  • Time of maximum observed plasma concentration (Tmax) [Time frame: Up to 3 years]
  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [Time frame: Up to 3 years]

Eligibility criteria

Inclusion criteria

  • Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).
  • Participants must, for Arm D, have a PD-L1 expression (≥50%).
  • Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.

Exclusion criteria

  • Participants must not have untreated central nervous system (CNS) metastases.
  • Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
  • Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.
  • Participants must not have a 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
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Johns Hopkins Hospital — Baltimore
  • NEXT Oncology — San Antonio
  • START Mountain Region — West Valley City
  • NEXT Virginia — Fairfax
Canada · 2 centers
  • BC Cancer Vancouver — Vancouver
  • Princess Margaret Cancer Centre — Toronto
Spain · 2 centers
  • Local Institution - 0006 — Badalona
  • Local Institution - 0008 — Hortaleza

Identifiers

NCT: NCT07223047 · CA256-0001 · 2025-523547-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗