Advanced Malignant TumorsPhase 1NCT06764771
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
A Phase 1 study testing BMS-986488, Adagrasib and Cetuximab in people with Advanced Malignant Tumors, run by Bristol-Myers Squibb at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- BMS-986488, Adagrasib and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 25 Mar 2025to 15 Oct 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Part 1B: solid tumors with KRAS G12C mutation.
- Part 2B: NSCLC with KRAS G12C mutation.
Show all 9Show fewer
- 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.
Who cannot join
- 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):.
- History of pneumonitis or interstitial lung disease (ILD).
- History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
8 sites in 3 countries
United States4 sites, 2 recruiting
- Active, not recruiting
Local Institution - 0020
Allentown, Pennsylvania, 18103
- Withdrawn
Local Institution - 0025
Dallas, Texas, 75390
- Recruiting
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
Daniel Vaena, Site 0024, 901-598-1454
- Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Martin Gutierrez, Site 0021, 551-996-5863
Canada3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0015
Montreal, Quebec, H2X 0A9
Site 0015
- Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Antoine Morin Coulombe, Site 0016, 4185254444
- Recruiting
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6
Christian Kollmannsberger, Site 0032, 6048776000
Australia1 site
- Active, not recruiting
Local Institution - 0031
Brisbane, Queensland, 4029
About this study
Official title: A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
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.
- Conditions
- Advanced Malignant Tumors
- Keywords
- Colorectal Cancer, CRC, Renal Cell Carcinoma, RCC, Non-Small Cell Lung Cancer, NSCLC, Cancer, Oncology, Phase 1, Solid Tumor
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986488Drug
Specified dose on specified days
AdagrasibDrug
Also called KRAZATI, BMS-986503, MRTX849
Specified dose on specified days
CetuximabDrug
Also called ERBITUX
Specified dose on specified days
NivolumabDrug
Also called OPDIVO, BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: BMS-986488 Monotherapy | Experimental | Not described Receives: Drug: BMS-986488 |
| Part 1B: BMS-986488 + Adagrasib | Experimental | Not described Receives: Drug: BMS-986488; Drug: Adagrasib |
| Part 1C: BMS-986488 + Adagrasib + Cetuximab | Experimental | Not described Receives: Drug: BMS-986488; Drug: Adagrasib; Drug: Cetuximab |
| Part 1D: BMS-986488 + Nivolumab | Experimental | Not described Receives: Drug: BMS-986488; Drug: Nivolumab |
| Part 2A: BMS-986488 Monotherapy | Experimental | Not described Receives: Drug: BMS-986488 |
| Part 2B: BMS-986488 + Adagrasib | Experimental | Not described Receives: Drug: BMS-986488; Drug: Adagrasib |
| Part 2C: BMS-986488 + Adagrasib + Cetuximab | Experimental | Not described Receives: Drug: BMS-986488; Drug: Adagrasib; Drug: Cetuximab |
| Part 2D: BMS-986488 + Nivolumab | Experimental | Not described Receives: Drug: BMS-986488; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Measured: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of participants with Serious AEs (SAEs)
Measured: 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
Measured: From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Number of participants with AEs leading to discontinuation
Measured: Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Number of deaths
Measured: From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
Measured: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Time of maximum observed concentration (Tmax)
Measured: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Measured: Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Objective response rate (ORR)
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)
Measured: From time of informed consent up to 52 weeks after end of treatment visit
Disease control rate (DCR)
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
Measured: From time of informed consent up to 52 weeks after end of treatment visit
Duration of response (DOR)
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
Measured: From time of informed consent up to 52 weeks after end of treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start25 Mar 2025
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 437 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764771
- Sponsor's protocol ID
- CA234-0001
- Status last verified
- Jul 2026
- First submitted
- 3 Jan 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html