Advanced Malignant Tumors
Conditions
Keywords
Colorectal Cancer, CRC, Renal Cell Carcinoma, RCC, Non-Small Cell Lung Cancer, NSCLC, Cancer, Oncology, Phase 1, Solid Tumor
Brief summary
This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
Interventions
DRUGBMS-986488
Specified dose on specified days
DRUGAdagrasib
Specified dose on specified days
DRUGCetuximab
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be ≥ 18 years of age. * Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. * Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). * Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation. ii) Part 2B: NSCLC with KRAS G12C mutation. iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation. * Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1. * Participants must have measurable disease per RECIST v1.1.
Exclusion criteria
* Untreated central nervous system (CNS) metastases. * Leptomeningeal metastasis (carcinomatous meningitis). * Impaired cardiac function or clinically significant cardiac disease. * For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD). ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). \- Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events (AEs) | Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) |
| Number of participants with Serious AEs (SAEs) | Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) |
| Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria | From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days) |
| Number of participants with AEs leading to discontinuation | Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) |
| Number of deaths | From time of informed consent up to 52 weeks after end of treatment visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Until Cycle 4, Day 1 (1 Cycle = 28 Days) | — |
| Time of maximum observed concentration (Tmax) | Until Cycle 4, Day 1 (1 Cycle = 28 Days) | — |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Until Cycle 4, Day 1 (1 Cycle = 28 Days) | — |
| Objective response rate (ORR) | From time of informed consent up to 52 weeks after end of treatment visit | Defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) |
| Disease control rate (DCR) | From time of informed consent up to 52 weeks after end of treatment visit | Defined as the proportion of participants who achieve a best response of CR, PR, or stable disease (SD) assessed by the investigator using RECIST v1.1 |
| Duration of response (DOR) | From time of informed consent up to 52 weeks after end of treatment visit | Defined as the time between the date of first documented response (CR or PR) to the date of the first documented disease progression as assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first |
Countries
Australia, Canada, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed