ClinicalTrials.gg
RecruitingNCT06618287Updated Sep 23, 2026

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 interventional study of BMS-986507 and Osimertinib in Lung Cancer and Breast Cancer, sponsored by Bristol-Myers Squibb. Recruiting at 65 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.

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Phase
Phase 1/2
Study type
Interventional
Enrollment
416
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 40 studies in Lung Neoplasms by Bristol-Myers Squibb — 6 open to participants now, 9 under way, 2 of them phase 3. Lung Neoplasms · Bristol-Myers Squibb.

Planned enrollment
10th of 34
416 · median 220
Started
2025
with 2 others
Phase 1/2
4 of 40
3 open now
Registered
36th of 40
by date

Among the 40 studies in Lung Neoplasms by Bristol-Myers Squibb, this one is the 10th largest by planned enrollment of the 34 interventional ones that give a count, is one of 3 that started in 2025, is one of 4 in phase 1/2, and was the 36th registered.

Lung Neoplasms

5,423 studies on the registry are indexed under Lung Neoplasms; 1,345 are open to participants now.

Browse Lung Neoplasms studies →

Open to participants now

6 of the 40 studies in Lung Neoplasms by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Who these studies take

Of the 995 Lung Neoplasms studies recruiting now, 682 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 40 studies in Lung Neoplasms by Bristol-Myers Squibb, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Lung Cancer
  • Breast Cancer

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)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have at least one per .
  • Participants must have an (ECOG) Performance Status of 0 or 1.
  • Participants must have a of at least 3 months at the time of the first dose.
  • Group A: Participants must have confirmed locally advanced or 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, -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 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

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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
416 participants (estimated)

Study arms

  • Experimental
    Group A

    Drug: BMS-986507 · Drug: Osimertinib

  • Experimental
    Group B

    Drug: BMS-986507 · Drug: Pembrolizumab

  • Experimental
    Group C

    Drug: BMS-986507 · Drug: Nivolumab

  • Experimental
    Group D

    Drug: BMS-986507 · Drug: Pumitamig

  • Experimental
    Group E

    Drug: BMS-986507 · Drug: Pumitamig

Interventions

  • Specified dose on specified days

    Also known as: Iza-bren, Izalontamab brengitecan

  • Specified dose on specified days

  • Specified dose on specified days

  • Specified dose on specified days

    Also known as: Opdivo, BMS-936558

  • Specified dose on specified days

    Also known as: BMS-986545, BNT327, PM8002

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 3 years

  5. Number of participants with AEs leading to death

    Time frame: Up to 3 years

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

    Time frame: Up to 3 weeks

Secondary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Up to 3 years

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

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

    Time frame: Up to 3 years

  5. Objective response rate (ORR)

    Time frame: Up to 2 year

07

Study locations

47 of 65 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Recruiting
    • Aakash Desai, Site 0066 · Contact919-525-0054
  • University of Miami Hospital and Clinics, Sylvester Cancer Center
    Miami, Florida 33136, United States
    Recruiting
    • Gilberto DE LIMA LOPES JUNIOR, Site 0009 · Contact305-243-1086
  • Local Institution - 0065
    Iowa City, Iowa 52242, United States
    Not yet recruiting
    • Site 0065 · Contact
  • Local Institution - 0140
    St Louis, Missouri 63110, United States
    Not yet recruiting
    • Site 0140 · Contact
  • John Theurer Cancer Center at Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Recruiting
    • Martin Gutierrez, Site 0010 · Contact551-996-5863
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    Recruiting
    • Khaled Hassan, Site 0029 · Contact734-615-2939
  • Local Institution - 0102
    Columbus, Ohio 43212, United States
    Not yet recruiting
    • Site 0102 · Contact
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
    Recruiting
    • David Page, Site 0090 · Contact503-215-5401
  • Providence St. Vincent Medical Center
    Portland, Oregon 97225, United States
    Recruiting
    • David Page, Site 0134 · Contact503-215-5401
  • Local Institution - 0052
    Portland, Oregon 97239, United States
    Not yet recruiting
    • Site 0052 · Contact
  • Local Institution - 0014
    Pittsburgh, Pennsylvania 15232, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • University of Tennessee Medical Center
    Knoxville, Tennessee 37920, United States
    Recruiting
    • Sarah Jenkins, Site 0103 · Contact865-305-8780
  • NEXT Oncology - Irving
    Irving, Texas 75039, United States
    Recruiting
    • Michael Song, Site 0092 · Contact210-580-9500
  • Swedish Medical Center
    Seattle, Washington 98104, United States
    Recruiting
    • Siddhartha Devarakonda, Site 0012 · Contact206-386-2457
  • Liverpool Hospital
    Liverpool, New South Wales 2170, Australia
    Recruiting
    • Abhijit Pal, Site 0027 · Contact61287389744
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
    Recruiting
    • Wen Xu, Site 0028 · Contact07 3176 3246
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3000, Australia
    Recruiting
    • Peter Savas, Site 0108 · Contact+61 3 8559 5000
  • St. John of God Subiaco Hospital
    Subiaco, Western Australia 6008, Australia
    Recruiting
    • Timothy Clay, Site 0101 · Contact+61 08 6465 9204
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
    Recruiting
    • Quincy Chu, Site 0024 · Contact7804328248
  • Local Institution - 0064
    Newmarket, Ontario L3Y 2P9, Canada
    Not yet recruiting
    • Site 0064 · Contact
  • Local Institution - 0023
    Ottawa, Ontario K1H 8L6, Canada
    Withdrawn

    Not enrolling at this site — choose another above.

  • The Ottawa Hospital - General Campus
    Ottawa, Ontario K1H 8L6, Canada
    Recruiting
    • Scott Laurie, Site 0026 · Contact6137377700
  • Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec H2X 3E4, Canada
    Recruiting
    • Marie Florescu, Site 0022 · Contact5148908000
  • Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
    Recruiting
    • Jennifer Friedmann, Site 0025 · Contact514340822224915
  • Local Institution - 0144
    Montreal, Quebec H4A3J1, Canada
    Not yet recruiting
    • Site 0144 · Contact
  • Oncocentro Valdivia
    Valdivia, Los Ríos Region 5112129, Chile
    Recruiting
    • Maria Herrera, Site 0105 · Contact+56992195434
  • FALP
    Santiago, Santiago Metropolitan 7500921, Chile
    Recruiting
    • Christian Caglevic, Site 0048 · Contact56224457254
  • Pontificia Universidad Catolica de Chile
    Santiago, Santiago Metropolitan 8330032, Chile
    Recruiting
    • Benjamin Walbaum, Site 0049 · Contact56976223722
  • Bradfordhill
    Santiago, Santiago Metropolitan 8420383, Chile
    Recruiting
    • Carlos Rojas, Site 0047 · Contact+56998744662
  • Oncocentro Apys
    Viña del Mar, Valparaiso 2520598, Chile
    Recruiting
    • Alejandro Acevedo Gaete, Site 0107 · Contact+56992369820
  • Local Institution - 0077
    Nice, Alpes-Maritimes 06189, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
    Bordeaux, Aquitaine 33076, France
    Recruiting
    • Sophie Cousin, Site 0043 · Contact33556333229
  • Centre Leon Berard
    Lyon, Auvergne-Rhône-Alpes 69008, France
    Recruiting
    • Aurelie Swalduz, Site 0050 · Contact+33469856041
  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
    Marseille, Bouches-du-Rhône 13385, France
    Recruiting
    • Laurent Greillier, Site 0045 · Contact33491324400
  • Local Institution - 0076
    Caen, Calvados 14076, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hôpital Arnaud de Villeneuve - CHU Montpellier
    Montpellier, Hérault 34090, France
    Recruiting
    • Benoit Roch, Site 0053 · Contact+33467330759
  • Gustave Roussy
    Villejuif, Val-de-Marne 94800, France
    Recruiting
    • David Planchard, Site 0041 · Contact33142114211
  • Institut Curie
    Paris, 75248, France
    Recruiting
    • nicolas girard, Site 0054 · Contact+33624456290
  • Hôpital Tenon
    Paris, 75970, France
    Recruiting
    • Jacques Cadranel, Site 0040 · Contact33156016531
  • Cro-Irccs
    Aviano, Friuli Venezia Giulia 33081, Italy
    Recruiting
    • Alessandra Bearz, Site 0034 · Contact390434659294
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milan, Lombardy 20133, Italy
    Recruiting
    • Giuseppe Lo Russo, Site 0033 · Contact390223903829
  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
    Candiolo, Torino 10060, Italy
    Recruiting
    • Vanesa Gregorc, Site 0056 · Contact390119933250
  • Azienda Ospedaliera Universitaria Careggi
    Florence, Tuscany 50134, Italy
    Recruiting
    • Lorenzo Antonuzzo, Site 0035 · Contact00390557947298
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
    Roma, 00168, Italy
    Recruiting
    • Gennaro Daniele, Site 0032 · Contact+390630153446
  • Leids Universitair Medisch Centrum
    Leiden, South Holland 2333 ZA, Netherlands
    Recruiting
    • Egbert Smit, Site 0004 · Contact31715262950
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
    Amsterdam, 1066 CX, Netherlands
    Recruiting
    • Gerrina Ruiter, Site 0003 · Contact0031205122958
  • CHUS - Hospital Clinico Universitario
    Santiago de Compostela, A Coruña [La Coruña] 15706, Spain
    Recruiting
    • Jorge Garcia Gonzalez, Site 0062 · Contact
  • Hospital Universitari Vall d'Hebron
    Barcelona, Barcelona [Barcelona] 08035, Spain
    Recruiting
    • Enriqueta Felip Font, Site 0016 · Contact34932746077
  • Institut Català d'Oncologia - L'Hospitalet
    Hospitalet, Barcelona [Barcelona] 08907, Spain
    Recruiting
    • NOELIA Vilarino Quintela, Site 0058 · Contact34932275402
  • Local Institution - 0059
    Barcelona, Catalunya [Cataluña] 08036, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Universitario 12 de Octubre
    Madrid, Madrid, Comunidad de 28041, Spain
    Recruiting
    • Luis Paz-Ares Rodriguez, Site 0018 · Contact0034913908922
  • Hospital Universitario Puerta de Hierro Majadahonda
    Majadahonda, Madrid, Comunidad de 28222, Spain
    Recruiting
    • Mariano Provencio Pulla, Site 0061 · Contact34911917759
  • Local Institution - 0118
    Valencia, Valenciana, Comunitat 46010, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Universitario Fundación Jiménez Díaz
    Madrid, 28040, Spain
    Recruiting
    • Ester García Lorenzo, Site 0017 · Contact
  • Local Institution - 0127
    Madrid, 28040, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Universitario HM Sanchinarro
    Madrid, 28050, Spain
    Recruiting
    • Ramon Yarza Barrio, Site 0019 · Contact349155048002805
  • H.R.U Málaga - Hospital General
    Málaga, 29011, Spain
    Recruiting
    • Manuel Cobo-Dols, Site 0063 · Contact00349422033350000
  • Local Institution - 0112
    Seville, 41009, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Universitari i Politecnic La Fe
    Valencia, 46026, Spain
    Recruiting
    • Oscar Juan Vidal, Site 0060 · Contact34961245877
  • Local Institution - 0147
    Tainan, 70428, Taiwan
    Not yet recruiting
    • Site 0147 · Contact
  • Local Institution - 0145
    Taipei, 100225, Taiwan
    Not yet recruiting
    • Site 0145 · Contact
  • Royal Free Hospital
    London, England NW32QG, United Kingdom
    Recruiting
    • Alexa Childs, Site 0030 · Contact442077040500
  • Local Institution - 0021
    Glasgow, Glasgow City G12 0YN, United Kingdom
    Not yet recruiting
    • Site 0021 · Contact
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, West Midlands B15 2GW, United Kingdom
    Recruiting
    • Gary Middleton, Site 0020 · Contact441214158237
  • Local Institution - 0001
    Newcastle upon Tyne, NE7 7DN, United Kingdom
    Not yet recruiting
    • Site 0001 · Contact
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Feb 2031, 72 months after the start.

Of 79 industry-sponsored phase 1/2 interventional studies under Lung Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 82. This study's planned 72 months is above that.

Counting every sponsor, half of 157 studies reached it within 54 months; a quarter within 40 and three quarters within 93.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2024
First posted
Oct 1, 2024
StartActual
Feb 4, 2025
Primary completionEst.
Feb 26, 2031
CompletionEst.
Feb 26, 2031
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06618287
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Feb 4, 2025
Primary completion
Feb 26, 2031 (estimated)
Completion
Feb 26, 2031 (estimated)
Last update
Sep 23, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Izalontamab brengitecan · Pumitamig

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