Recruiting NCT04895709
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
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-986340, BMS-936558-01, Docetaxel, Pumitamig.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung 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, Germany, Israel +3
- 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 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Overview
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.
Interventions
- Drug BMS-986340
Specified dose on specified days - Drug BMS-936558-01
Specified dose on specified days - Drug Docetaxel
Specified dose on specified days - Drug Pumitamig
Specified dose on specified days
Primary outcome measures
- Incidence of adverse events (AEs) [Time frame: Up to 120 weeks]
- Incidence of serious adverse events (SAEs) [Time frame: Up to 120 weeks]
- Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [Time frame: Up to either 21 or 28 days]
- Incidence of AEs leading to discontinuation [Time frame: Up to 120 weeks]
- Number of deaths [Time frame: Up to 120 weeks]
Secondary outcome measures (12)
- Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with docetaxel: Cmax [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with docetaxel: Tmax [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) [Time frame: Up to 120 weeks]
- PK parameters of BMS-986340 administered in combination with docetaxel: Ctau [Time frame: Up to 120 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Community Cancer Institute — Clovis
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- University of Iowa — Iowa City
- John Theurer Cancer Center — Hackensack
- Local Institution - 0006 — New York
- Local Institution - 0002 — New York
- Providence Cancer Center Oncology and Hematology Care- Eastside — Portland
- … and 3 more centers
Spain · 7 centers
- Hospital Universitario Virgen de la Victoria — Málaga
- Institut Catalan d Oncologia (ICO) - Badalona — Badalona
- Hospital Universitari Vall d'Hebron — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD — Madrid
- Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid — Madrid
- Clinica Universidad de Navarra-oNCOLOGY — Pamplona
Australia · 6 centers
- Blacktown Hospital — Blacktown
- Liverpool Hospital — Liverpool
- Princess Alexandra Hospital — Brisbane
- Cabrini Hospital - Malvern — Malvern
- St Vincent's Hospital — Melbourne
- One Clinical Research — Nedlands
Canada · 6 centers
- Cross Cancer Institute — Edmonton
- Local Institution - 0030 — Vancouver
- Hamilton Health Sciences-Juravinski Cancer Centre — Hamilton
- Local Institution - 0009 — Toronto
- Centre Hospitalier de luniversite de Montreal — Montreal
- Local Institution - 0016 — Ottawa
Italy · 6 centers
- Humanitas — Rozzano
- Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 — Milan
- Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma
- ospedale le scotte-U.O.C. Immunoterapia Oncologica — Siena
Germany · 5 centers
- Local Institution - 0044 — Ulm
- Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Tr — Dresden
- Universitaetsklinikum Essen — Essen
- Universitatsklinikum Frankfurt — Frankfurt
- Universitaetsklinikum Wuerzburg — Würzburg
Israel · 5 centers
- Rabin Medical Center — Petah Tikva
- Local Institution - 0035 — Ramat Gan
- Sheba Medical Center — Ramat Gan
- Rambam Health Care Campus — Haifa
- Sourasky Medical Center — Tel Aviv
Japan · 1 center
- National Cancer Center Hospital East — Kashiwa
Identifiers
NCT: NCT04895709 · CA052-002 · 2023-503651-10 · U1111-1265-4508