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Taking people in CanadaPhase 1/2

Tests BMS-986523 alone and with other cancer drugs in advanced solid tumors

Tests the drug BMS-986523, alone or combined, in adults with advanced solid cancers.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Toronto and Vancouver, CanadaSee the 2 sitesAlso in 2 other countries, 6 sites
Registry title
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
Status
Recruiting
Phase
Phase 1/2
People taking part
252 people, planned
Started
25 Nov 2025
Expected to end
13 Oct 2028
Type of study
Interventional, 6 groups
Treatments tested
  • BMS-986523
  • Gemcitabine
  • Nab-Paclitaxel
  • Cetuximab
  • Pembrolizumab
Record updated
28 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumours that cannot be removed by surgery or have spread, and that have a known KRAS change.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced tumour that cannot be removed by surgery, or metastatic solid tumour, confirmed under the microscope. Conditions listed: non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma.
Earlier treatment
Must have already had the standard treatments set by the protocol, or cannot have them, or decline them after being given enough information.
Biomarker or test result
A known KRAS change (mutation or amplification). For Arm D, PD-L1 expression of ≥50%.

Main reasons for not taking part

  • Untreated metastases in the brain or spinal cord (central nervous system)
  • Another cancer needing treatment now, or another cancer active within the past 2 years
  • Past or current interstitial lung disease or active non-infectious pneumonitis (past radiation pneumonitis in the radiation field is allowed)
  • Past severe skin reactions such as Stevens-Johnson Syndrome or toxic epidermal necrolysis

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)
  • 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 untreated central nervous system (CNS) metastases
  • Other protocol-defined Inclusion/Exclusion criteria apply

Where in Canada

Also in 2 other countries, 6 sites

  • Princess Margaret Cancer CentreToronto, CanadaContact: Albiruni Abdul Razak, Site 0010Taking people
  • BC Cancer - VancouverVancouver, CanadaContact: Daniel Renouf, Site 0002Taking people

About the trial

What the trial wants to find out

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

The 6 groups in the trial

  • Arm ATreatment being tested

    Treatment: BMS-986523

  • Arm BTreatment being tested

    Treatment: BMS-986523

  • Arm CTreatment being tested

    Treatment: BMS-986523

  • Arm DTreatment being tested

    Treatment: BMS-986523 and Pembrolizumab

  • Arm ETreatment being tested

    Treatment: BMS-986523 and Cetuximab

  • Arm FTreatment being tested

    Treatment: BMS-986523, Gemcitabine, and Nab-Paclitaxel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests BMS-986523 alone and with other cancer drugs in advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 May 2026