Menu
Recruiting NCT06618287

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Phase I / Phase II Interventional Lung Cancer Breast Cancer

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-986507, Osimertinib, Pembrolizumab, Nivolumab.
Who it may be relevant to
Registry conditions: Lung Cancer, Breast Cancer. 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, Chile, France +4
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, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

Overview

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Interventions

  • Drug BMS-986507
    Specified dose on specified days
  • Drug Osimertinib
    Specified dose on specified days
  • Drug Pembrolizumab
    Specified dose on specified days
  • Drug Nivolumab
    Specified dose on specified days
  • Drug Pumitamig
    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) critera [Time frame: Up to 3 years]
  • Number of participants with AEs leading to discontinuation [Time frame: Up to 3 years]
  • Number of participants with AEs leading to death [Time frame: Up to 3 years]
  • Number of DLTs that occur during the DLT evaluation period [Time frame: Up to 3 weeks]
Secondary outcome measures (5)
  • Maximum observed serum concentration (Cmax) [Time frame: Up to 3 years]
  • Time of maximum observed concentration (Tmax) [Time frame: Up to 3 years]
  • Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Time frame: Up to 3 years]
  • Area under the serum concentration-time curve within a dosing interval (AUC(TAU)) [Time frame: Up to 3 years]
  • Objective response rate (ORR) [Time frame: Up to 2 year]

Eligibility criteria

Inclusion criteria

  • Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participants must have a life expectancy of at least 3 months at the time of the first dose.
  • Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed
  • Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC.
  • Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC.
  • Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen.
  • Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.

Exclusion criteria

  • Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
  • Participants with known mutations in EGFR will be excluded (Group A,B and E).
  • Participants must not have a history of serious recurrent infections.
  • Participants must not have a history of severe heart disease.
  • 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
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • University of Alabama at Birmingham — Birmingham
  • University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami
  • Local Institution - 0065 — Iowa City
  • John Theurer Cancer Center at Hackensack University Medical Center — Hackensack
  • Cleveland Clinic — Cleveland
  • Local Institution - 0102 — Columbus
  • Providence Portland Medical Center — Portland
  • Providence St. Vincent Medical Center — Portland
  • … and 5 more centers
Spain · 13 centers
  • CHUS - Hospital Clinico Universitario — Santiago de Compostela
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Institut Català d'Oncologia - L'Hospitalet — Hospitalet
  • Local Institution - 0059 — Barcelona
  • Hospital Universitario 12 de Octubre — Madrid
  • Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda
  • Local Institution - 0118 — Valencia
  • Hospital Universitario Fundación Jiménez Díaz — Madrid
  • … and 5 more centers
France · 9 centers
  • Local Institution - 0077 — Nice
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux
  • Centre Leon Berard — Lyon
  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille
  • Local Institution - 0076 — Caen
  • Hôpital Arnaud de Villeneuve - CHU Montpellier — Montpellier
  • Gustave Roussy — Villejuif
  • Institut Curie — Paris
  • … and 1 more center
Canada · 6 centers
  • Cross Cancer Institute — Edmonton
  • Local Institution - 0064 — Newmarket
  • Local Institution - 0023 — Ottawa
  • The Ottawa Hospital - General Campus — Ottawa
  • Centre Hospitalier de l'Université de Montréal — Montreal
  • Jewish General Hospital — Montreal
Chile · 5 centers
  • Local Institution - 0105 — Valdivia
  • Local Institution - 0048 — Santiago
  • Local Institution - 0049 — Santiago
  • Local Institution - 0047 — Santiago
  • Local Institution - 0107 — Viña del Mar
Italy · 5 centers
  • Cro-Irccs — Aviano
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo
  • Azienda Ospedaliera Universitaria Careggi — Florence
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma
Australia · 4 centers
  • Liverpool Hospital — Liverpool
  • Princess Alexandra Hospital — Woolloongabba
  • Peter MacCallum Cancer Centre — Melbourne
  • Local Institution - 0101 — Subiaco
United Kingdom · 4 centers
  • Royal Free Hospital — London
  • Local Institution - 0021 — Glasgow
  • University Hospitals Birmingham NHS Foundation Trust — Birmingham
  • Local Institution - 0001 — Newcastle upon Tyne
Netherlands · 2 centers
  • Leids Universitair Medisch Centrum — Leiden
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) — Amsterdam

Identifiers

NCT: NCT06618287 · CA244-0001 · 2024-514947-27 · U1111-1308-2752

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗