What this study is
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
What's being tested
- BMS-986340
Intervention · DRUG
- BMS-936558-01
Intervention · DRUG
- Docetaxel
Intervention · DRUG
- Pumitamig
Intervention · DRUG
All interventions
Specified dose on specified days
Study details
- Official title
- A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
- Sponsor
- Bristol-Myers Squibb
- Conditions
- Cervical Cancer · Gastric/Gastroesophageal Junction Adenocarcinoma · Microsatellite Stable Colorectal Cancer · Non-Small-Cell Lung Cancer · Squamous Cell Carcinoma of Head and Neck · Carcinoma, Renal Cell · Urothelial Carcinoma · Pancreatic Adenocarcinoma · Melanoma · Ovarian Neoplasms · Triple Negative Breast Neoplasms
- Enrolling
- 1,109 people
- Starts
- 2021-05-27
- Est. completion
- 2031-08-31
- Design
- Open-label, randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 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 the most recent therapy.
- Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
- Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
You can't join if
- 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 prior to the first dose of study treatment.
- Active, known, or suspected autoimmune disease.
- Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.
- Prior organ or tissue allograft.
- Uncontrolled or significant cardiovascular disease.
- Major surgery within 4 weeks of study drug administration.
- History of or with active interstitial lung disease or pulmonary fibrosis.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (47)
39 openCommunity Cancer Institute
Clovis, California, United States
- Uzair Chaudhary, Site 0032 · Contact559-387-1600
RecruitingUSC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
- Anthony El-Khoueiry, Site 0041 · Contact323-865-3967
RecruitingHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
- Carlos Becerra, Site 0050 · Contact949-764-8222
Recruiting- Recruiting
John Theurer Cancer Center
Hackensack, New Jersey, United States
- Martin Gutierrez, Site 0007 · Contact551-996-5863
RecruitingProvidence Cancer Center Oncology and Hematology Care- Eastside
Portland, Oregon, United States
- Rom Leidner, Site 0001 · Contact503-215-5696
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
- Jordan Berlin, Site 0052 · Contact615-936-1796
RecruitingHouston Methodist Hospital
Houston, Texas, United States
- Maen Abdelrahim, Site 0061 · Contact346-241-5495
RecruitingLocal Institution - 0006
New York, New York, United States
CompletedLocal Institution - 0002
New York, New York, United States
CompletedLocal Institution - 0063
Nashville, Tennessee, United States
Withdrawn
36 sites outside the US
Blacktown Hospital
Blacktown, New South Wales, Australia
- Adnan Nagrial, Site 0057 · Contact+61 02 86705071
Recruiting- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, Australia
- Aaron Hansen, Site 0054 · Contact61731765564
RecruitingCabrini Hospital - Malvern
Malvern, Victoria, Australia
- Shehara Mendis, Site 0053 · Contact(03)95083434
Recruiting- Recruiting
One Clinical Research
Nedlands, Western Australia, Australia
- Muhammad Khattak, Site 0056 · Contact+61 08 6279 9466
Recruiting- Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario, Canada
- Sebastien Hotte, Site 0029 · Contact905-387-9495
RecruitingCentre Hospitalier de luniversite de Montreal
Montreal, Quebec, Canada
- Rahima Jamal, Site 0015 · Contact51489080008444
RecruitingUniversitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
Dresden, Germany
- Martin Wermke, Site 0010 · Contact+493514587566
Recruiting- Recruiting
- Recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, Central District, Israel
- Salomon Stemmer, Site 0036 · Contact97239378076
Recruiting- Recruiting
Rambam Health Care Campus
Haifa, Northern District, Israel
- Talia Shentzer Kutiel, Site 0039 · Contact97247776700
Recruiting- Recruiting
- Recruiting
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy
- Vanesa Gregorc, Site 0033 · Contact390119933250
RecruitingFondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
Milan, Italy
- Filippo De Braud, Site 0024 · Contact390223903066
RecruitingIstituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Italy
- Paolo Ascierto, Site 0034 · Contact390815903431
RecruitingFondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy
- Gennaro Daniele, Site 0040 · Contact+390630153446
Recruitingospedale le scotte-U.O.C. Immunoterapia Oncologica
Siena, Italy
- Michele Maio, Site 0025 · Contact390577586335
RecruitingNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
- Yasutoshi Kuboki, Site 0064 · Contact81471331111
RecruitingHospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
- Javier Garcia Corbacho, Site 0048 · Contact951032250
RecruitingInstitut Catalan d Oncologia (ICO) - Badalona
Badalona, Barcelona [Barcelona], Spain
- Cinta Hierro Carbo, Site 0014 · Contact34934978925
RecruitingHospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
- Elena Garralda Cabanas, Site 0049 · Contact349327460004910
RecruitingHospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
- Luis Paz-Ares Rodriguez, Site 0047 · Contact0034913908922
RecruitingHospital Universitario Fundación Jiménez Díaz-START Madrid-FJD
Madrid, Spain
- Victor Moreno Garcia, Site 0013 · Contact915504800ext2805
RecruitingCentro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC
Madrid, Spain
- Emiliano Calvo, Site 0011 · Contact+34934894304
RecruitingClinica Universidad de Navarra-oNCOLOGY
Pamplona, Spain
- Ignacio Melero Bermejo, Site 0012 · Contact34948255400
RecruitingLocal Institution - 0030
Vancouver, British Columbia, Canada
CompletedLocal Institution - 0009
Toronto, Ontario, Canada
CompletedLocal Institution - 0016
Ottawa, Canada
CompletedLocal Institution - 0044
Ulm, Baden-Wurttemberg, Germany
CompletedLocal Institution - 0035
Ramat Gan, Central District, Israel
Withdrawn
Study team
Sponsor
Bristol-Myers Squibb
Study ID CA052-002
Study director
Bristol-Myers Squibb
Bristol-Myers Squibb
CONTACT
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.