A Phase 1 Study of BMS-986406 as Monotherapy and in Combination in Advanced Tumors

JRCT ID: jRCT2031230298

Registered date:18/08/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: advanced tumors
• Date of first enrollment: 11/09/2023
• Target sample size: 154
• Countries of recruitment: Belgium,Japan,Spain,Japan,Argentina,Japan,South Korea,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Part 1A: BMS-986406(Monotherapy Dose Escalation)
Part 1B: BMS-986406+Nivolumab(Combination Dose Escalation)
Part 1C: BMS-986406+Nivolumab(Indication-Specific Dose Expansion)
Part 1D: BMS-986406+Nivolumab+Carboplatin with Pemetrexed or Paclitaxel

Outcome(s)

Primary Outcome

-Number of participants with adverse events (AEs)
-Number of participants with serious adverse events (SAEs)
-Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
-Number of participants with AEs leading to discontinuation
-Number of participants with death

Secondary Outcome

-Maximum observed plasma concentration (Cmax)
-Time of Maximum observed plasma concentration (Tmax)
-Trough observed plasma concentration (Ctrough)
-Incidence of anti-drug antibody (ADAs)
-Objective response rate (ORR)
-Disease control rate (DCR)
-Duration of response (DOR)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Part1A,1B,1C;
Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease
Part1D;
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.
All Parts;
-Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
-Eastern Cooperative Oncology Group Performance Status of 0 or 1
-Adequate organ function

Exclude criteria

-Prior organ or tissue allograft
-Leptomeningeal metastases
-Untreated CNS metastases
-Serious or uncontrolled medical disorders

Related Information

• Primary Sponsor: Walker Justin
• Secondary ID(s): NCT05298592