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Lung CancerPhase 1/2NCT06618287

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

A Phase 1/2 study testing BMS-986507, Osimertinib and Pembrolizumab in people with Lung Cancer and Breast Cancer, run by Bristol-Myers Squibb at 65 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Breast Cancer
What is being tested?
BMS-986507, Osimertinib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
65 sitesin 10 countries
Study dates
4 Feb 2025to 26 Feb 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

65 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

65 sites in 10 countries

United States14 sites, 13 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Aakash Desai, Site 0066, 919-525-0054

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Khaled Hassan, Site 0029, 734-615-2939

    Recruiting

  • Local Institution - 0102

    Columbus, Ohio, 43212

    Site 0102

    Not yet recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Martin Gutierrez, Site 0010, 551-996-5863

    Recruiting

  • Local Institution - 0065

    Iowa City, Iowa, 52242

    Site 0065

    Not yet recruiting

  • NEXT Oncology - Irving

    Irving, Texas, 75039

    Michael Song, Site 0092, 210-580-9500

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Sarah Jenkins, Site 0103, 865-305-8780

    Recruiting

  • University of Miami Hospital and Clinics, Sylvester Cancer Center

    Miami, Florida, 33136

    Gilberto DE LIMA LOPES JUNIOR, Site 0009, 305-243-1086

    Recruiting

  • Local Institution - 0014

    Pittsburgh, Pennsylvania, 15232

    Withdrawn

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    David Page, Site 0090, 503-215-5401

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    David Page, Site 0134, 503-215-5401

    Recruiting

  • Local Institution - 0052

    Portland, Oregon, 97239

    Site 0052

    Not yet recruiting

  • Swedish Medical Center

    Seattle, Washington, 98104

    Siddhartha Devarakonda, Site 0012, 206-386-2457

    Recruiting

  • Local Institution - 0140

    St Louis, Missouri, 63110

    Site 0140

    Not yet recruiting

Other trials in United States

Spain13 sites, 9 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

    Enriqueta Felip Font, Site 0016, 34932746077

    Recruiting

  • Local Institution - 0059

    Barcelona, Catalunya [Cataluña], 08036

    Withdrawn

  • Institut Català d'Oncologia - L'Hospitalet

    Hospitalet, Barcelona [Barcelona], 08907

    NOELIA Vilarino Quintela, Site 0058, 34932275402

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

    Luis Paz-Ares Rodriguez, Site 0018, 0034913908922

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Ester García Lorenzo, Site 0017

    Recruiting

  • Local Institution - 0127

    Madrid, 28040

    Withdrawn

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

    Ramon Yarza Barrio, Site 0019, 349155048002805

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Comunidad de, 28222

    Mariano Provencio Pulla, Site 0061, 34911917759

    Recruiting

  • H.R.U Málaga - Hospital General

    Málaga, 29011

    Manuel Cobo-Dols, Site 0063, 00349422033350000

    Recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [La Coruña], 15706

    Jorge Garcia Gonzalez, Site 0062

    Recruiting

  • Local Institution - 0112

    Seville, 41009

    Withdrawn

  • Local Institution - 0118

    Valencia, Valenciana, Comunitat, 46010

    Withdrawn

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Oscar Juan Vidal, Site 0060, 34961245877

    Recruiting

Other trials in Spain

France9 sites, 7 recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076

    Sophie Cousin, Site 0043, 33556333229

    Recruiting

  • Local Institution - 0076

    Caen, Calvados, 14076

    Withdrawn

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008

    Aurelie Swalduz, Site 0050, +33469856041

    Recruiting

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

    Laurent Greillier, Site 0045, 33491324400

    Recruiting

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, Hérault, 34090

    Benoit Roch, Site 0053, +33467330759

    Recruiting

  • Local Institution - 0077

    Nice, Alpes-Maritimes, 06189

    Withdrawn

  • Institut Curie

    Paris, 75248

    nicolas girard, Site 0054, +33624456290

    Recruiting

  • Hôpital Tenon

    Paris, 75970

    Jacques Cadranel, Site 0040, 33156016531

    Recruiting

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94800

    David Planchard, Site 0041, 33142114211

    Recruiting

Other trials in France

Canada7 sites, 6 recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Quincy Chu, Site 0024, 7804328248

    Recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

    Marie Florescu, Site 0022, 5148908000

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Jennifer Friedmann, Site 0025, 514340822224915

    Recruiting

  • Local Institution - 0144

    Montreal, Quebec, H4A3J1

    Site 0144

    Not yet recruiting

  • Local Institution - 0064

    Newmarket, Ontario, L3Y 2P9

    Site 0064

    Not yet recruiting

  • Local Institution - 0023

    Ottawa, Ontario, K1H 8L6

    Withdrawn

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

    Scott Laurie, Site 0026, 6137377700

    Recruiting

Other trials in Canada

Chile5 sites, 5 recruiting

  • FALP

    Santiago, Santiago Metropolitan, 7500921

    Christian Caglevic, Site 0048, 56224457254

    Recruiting

  • Pontificia Universidad Catolica de Chile

    Santiago, Santiago Metropolitan, 8330032

    Benjamin Walbaum, Site 0049, 56976223722

    Recruiting

  • Bradfordhill

    Santiago, Santiago Metropolitan, 8420383

    Carlos Rojas, Site 0047, +56998744662

    Recruiting

  • Oncocentro Valdivia

    Valdivia, Los Ríos Region, 5112129

    Maria Herrera, Site 0105, +56992195434

    Recruiting

  • Oncocentro Apys

    Viña del Mar, Valparaiso, 2520598

    Alejandro Acevedo Gaete, Site 0107, +56992369820

    Recruiting

Other trials in Chile

Italy5 sites, 5 recruiting

  • Cro-Irccs

    Aviano, Friuli Venezia Giulia, 33081

    Alessandra Bearz, Site 0034, 390434659294

    Recruiting

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060

    Vanesa Gregorc, Site 0056, 390119933250

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

    Lorenzo Antonuzzo, Site 0035, 00390557947298

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

    Giuseppe Lo Russo, Site 0033, 390223903829

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168

    Gennaro Daniele, Site 0032, +390630153446

    Recruiting

Other trials in Italy

Australia4 sites, 4 recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

    Abhijit Pal, Site 0027, 61287389744

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Peter Savas, Site 0108, +61 3 8559 5000

    Recruiting

  • St. John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

    Timothy Clay, Site 0101, +61 08 6465 9204

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Wen Xu, Site 0028, 07 3176 3246

    Recruiting

Other trials in Australia

United Kingdom4 sites, 4 recruiting

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands, B15 2GW

    Gary Middleton, Site 0020, 441214158237

    Recruiting

  • Local Institution - 0021

    Glasgow, Glasgow City, G12 0YN

    Site 0021

    Not yet recruiting

  • Royal Free Hospital

    London, England, NW32QG

    Alexa Childs, Site 0030, 442077040500

    Recruiting

  • Local Institution - 0001

    Newcastle upon Tyne, NE7 7DN

    Site 0001

    Not yet recruiting

Other trials in United Kingdom

Netherlands2 sites, 2 recruiting

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)

    Amsterdam, 1066 CX

    Gerrina Ruiter, Site 0003, 0031205122958

    Recruiting

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA

    Egbert Smit, Site 0004, 31715262950

    Recruiting

Other trials in Netherlands

Taiwan2 sites, 2 recruiting

  • Local Institution - 0147

    Tainan, 70428

    Site 0147

    Not yet recruiting

  • Local Institution - 0145

    Taipei, 100225

    Site 0145

    Not yet recruiting

Other trials in Taiwan

About this study

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

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.

Being tested
BMS-986507, Osimertinib, Pembrolizumab, Nivolumab, Pumitamig
Keywords
Non-Small Cell Lung Cancer (NSCLC), Epidermal Growth Factor Receptor mutated (EGFRmt), Epidermal Growth Factor Receptor wild-type (EGFRwt), Triple-negative breast cancer (TNBC)
Medical subject headings
Lung Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986507Drug

    Also called Iza-bren, Izalontamab brengitecan

    Specified dose on specified days

  • OsimertinibDrug

    Specified dose on specified days

  • PembrolizumabDrug

    Specified dose on specified days

  • NivolumabDrug

    Also called Opdivo, BMS-936558

    Specified dose on specified days

  • PumitamigDrug

    Also called BMS-986545, BNT327, PM8002

    Specified dose on specified days

Study groups in NCT06618287
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: BMS-986507; Drug: Osimertinib
Group BExperimentalNot described
Receives: Drug: BMS-986507; Drug: Pembrolizumab
Group CExperimentalNot described
Receives: Drug: BMS-986507; Drug: Nivolumab
Group DExperimentalNot described
Receives: Drug: BMS-986507; Drug: Pumitamig
Group EExperimentalNot described
Receives: Drug: BMS-986507; Drug: Pumitamig

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    Measured: Up to 3 years

  2. Number of participants with serious adverse events (SAEs)

    Measured: Up to 3 years

  3. Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera

    Measured: Up to 3 years

  4. Number of participants with AEs leading to discontinuation

    Measured: Up to 3 years

  5. Number of participants with AEs leading to death

    Measured: Up to 3 years

  6. Number of DLTs that occur during the DLT evaluation period

    Measured: Up to 3 weeks

Secondary outcomes (5)

  1. Maximum observed serum concentration (Cmax)

    Measured: Up to 3 years

  2. Time of maximum observed concentration (Tmax)

    Measured: Up to 3 years

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Measured: Up to 3 years

  4. Area under the serum concentration-time curve within a dosing interval (AUC(TAU))

    Measured: Up to 3 years

  5. Objective response rate (ORR)

    Measured: Up to 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start4 Feb 2025
  3. Primary completion26 Feb 2031 (estimated)
  4. Study completion26 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
416 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06618287
Sponsor's protocol ID
CA244-0001
Other IDs
2024-514947-27, U1111-1308-2752
Status last verified
Sep 2026
First submitted
26 Sep 2024
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986507, Osimertinib and Pembrolizumab in people with Lung Cancer and Breast Cancer, run by Bristol-Myers Squibb at 65 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Spain, France, Canada, Chile and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Up to 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06618287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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