Actively Recruiting
A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Led by Bristol-Myers Squibb · Updated on 2026-06-04
1109
Participants Needed
47
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BMS-986340, both alone and combined with other drugs—nivolumab, docetaxel, or pumitamig—in people with advanced solid tumors. This is a first-in-human study aiming to understand the safety, tolerability, and best doses of BMS-986340 in this population. The study includes adults with various advanced cancers who have previously received standard treatments. Participants receive BMS-986340 as monotherapy or in combination with one of the other drugs. The study is organized into several parts including dose escalation and dose expansion phases for both monotherapy and combination therapies. Each treatment is given on specified days, with careful monitoring of drug levels and immune responses over time. Throughout the study, participants undergo tumor biopsies and regular assessments to measure treatment effects and side effects. Researchers track adverse events, serious side effects, and any issues leading to treatment changes or discontinuation. Outcome measures include tumor response rates and progression-free survival, monitored up to 120 weeks. The study involves safety monitoring, pharmacokinetic evaluations, and disease assessments at regular intervals to gather comprehensive data on the treatments.
CONDITIONS
Brief Title
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
- Measurable disease per RECIST v1.1 with at least one lesion accessible for biopsy; fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Radiographically documented progressive disease on or after most recent therapy.
- Received standard-of-care therapies, including a programmed death (ligand)-1 inhibitor effective for the tumor type, except in certain combination therapy parts where prior docetaxel use excludes participation.
- Advanced or metastatic disease and refractory to, not a candidate for, or intolerant of existing therapies known to provide clinical benefit for their condition.
You will not qualify if you...
- Women who are pregnant or breastfeeding.
- Primary central nervous system (CNS) malignancy.
- Untreated CNS metastases.
- Leptomeningeal metastases.
- Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years before first study dose.
- Active, known, or suspected autoimmune disease.
- Condition requiring systemic corticosteroids within 14 days or other immunosuppressive medications within 30 days before first study dose.
- Prior organ or tissue allograft.
- Uncontrolled or significant cardiovascular disease.
- Major surgery within 4 weeks before study drug administration.
- History of or active interstitial lung disease or pulmonary fibrosis.
- Other protocol-defined inclusion/exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 weeks
Participants receive specified doses of BMS-986340 alone or in combination with other drugs as part of the study treatment.
Visits scheduled based on dosing and monitoring requirements
Duration - Up to 120 weeks
Participants are monitored for safety, response to treatment, and long-term outcomes.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 47 locations
1
Community Cancer Institute
Clovis, California, United States, 93611
Actively Recruiting
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Local Institution - 0006
New York, New York, United States, 10032
Completed
7
Local Institution - 0002
New York, New York, United States, 10065
Completed
8
Providence Cancer Center Oncology and Hematology Care- Eastside
Portland, Oregon, United States, 97213
Actively Recruiting
9
Local Institution - 0063
Nashville, Tennessee, United States, 37067
Not Yet Recruiting
10
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
11
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
12
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
13
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
14
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Actively Recruiting
15
Cabrini Hospital - Malvern
Malvern, Victoria, Australia, 3144
Actively Recruiting
16
St Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Actively Recruiting
17
One Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
18
Cross Cancer Institute
Edmonton, Alberta, Canada, T6X 1E8
Actively Recruiting
19
BC Cancer Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
20
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V5C2
Actively Recruiting
21
Local Institution - 0009
Toronto, Ontario, Canada, M5G 2M9
Completed
22
Centre Hospitalier de luniversite de Montreal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
23
The Ottawa Hospital Cancer Centre
Ottawa, Canada, K1H 8L6
Actively Recruiting
24
Local Institution - 0044
Ulm, Baden-Wurttemberg, Germany, 89081
Completed
25
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
Dresden, Germany, 01307
Actively Recruiting
26
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
27
Universitatsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
28
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97078
Actively Recruiting
29
Rabin Medical Center
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
30
Local Institution - 0035
Ramat Gan, Central District, Israel, 5265601
Withdrawn
31
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
32
Rambam Health Care Campus
Haifa, Northern District, Israel, 3109601
Actively Recruiting
33
Sourasky Medical Center
Tel Aviv, Tell Abīb, Israel, 6423906
Actively Recruiting
34
Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
35
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy, 10060
Actively Recruiting
36
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
Milan, Italy, 20133
Actively Recruiting
37
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Italy, 80131
Actively Recruiting
38
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
39
ospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, Italy, 53100
Actively Recruiting
40
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
41
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain, 29010
Actively Recruiting
42
Institut Catalan d Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], Spain, 08916
Actively Recruiting
43
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
44
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain, 28041
Actively Recruiting
45
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD
Madrid, Spain, 28040
Actively Recruiting
46
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC
Madrid, Spain, 28050
Actively Recruiting
47
Clinica Universidad de Navarra-oNCOLOGY
Pamplona, Spain, 31008
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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