A Phase 1/2 Study of BMS-986340 with and without Nivolumab or Docetaxel in Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 May 2022 → ongoing

Decision date (initial)

2023-08-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-503651-10-00

EudraCT number

2021-001188-26

WHO UTN

U1111-1265-4508

ClinicalTrials.gov

NCT04895709

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Therapy, Pharmacodynamic, Efficacy

To assess the safety, tolerability, and to determine the MTD, MAD,
and/or RP2D(s) of BMS-986340 administered as monotherapy and in
combination with nivolumab or docetaxel

Secondary objectives 3

1. To characterize the PK profile of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel
2. To characterize the immunogenicity of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel
3. To assess the preliminary anti-tumor activity of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel

Conditions and MedDRA coding

Male and female participants ≥ 18 years of age with advanced or metastatic cancers

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
3. Eastern Cooperative Oncology Group Performance Status of 0 or 1
4. Radiographically documented progressive disease on or after the most recent therapy
5. Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded)
6. Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC. - Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. Other protocol-defined inclusion criteria apply.

Exclusion criteria 11

1. Women who are pregnant or breastfeeding
2. Primary central nervous system (CNS) malignancy
3. Untreated CNS metastases
4. Leptomeningeal metastases
5. Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
6. Active, known, or suspected autoimmune disease
7. Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
8. Prior organ or tissue allograft
9. Uncontrolled or significant cardiovascular disease
10. Major surgery within 4 weeks of study drug administration
11. History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death

Secondary endpoints 3

1. Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel
2. Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab or docetaxel
3. ORR, DCR, DOR, and PFSR

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 18

Locations

3 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications