NCT06024174CompletedPhase 1/2
Study of BMS-986466 with Adagrasib with or without Cetuximab in Participants with KRAS G12C-mutant Solid Tumors
Phase 1/2 Open-label Study of BMS-986466 in Combination with Adagrasib with or without Cetuximab in Participants with KRAS G12C-mutant Advanced Solid Tumors
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Mar 2024
Brief summary (registry, in English)
1.To determine if the study treatment is safe and well-tolerated by the patients; to find the safe Maximum Tolerated Dose (MTD). If MTD is not reached the study will determine the Maximum Administered Dose (MAD). The study will identify dose levels for further testing: in Part 1A, BMS-986466 will be given with adagrasib to patients with advanced KRAS G12C mutant NSCLC, CRC, Pancreatic Duct Adenocarcinoma (PDAC), and Biliary Tract Cancer (BTC). In Part 1B, BMS-986466 will be given with adagrasib and cetuximab to participants with advanced KRAS G12C mutant CRC. 2.To determine if the study treatment is effective against cancer: - Part 2A: BMS-986466 given with adagrasib versus adagrasib alone in KRAS G12C mutant NSCLC naive to treatment with KRAS G12C inhibitor (G12Ci naive) -Part 2B: BMS-986466 given with adagrasib with or without cetuximab versus adagrasib plus cetuximab in KRAS G12C mutant, G12Ci naive CRC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 20 Sept 2023
- Start date
- 1 Jan 2024
- Lead sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Diseases
- Lung cancer
- NCT number
- NCT06024174
- EU CT number
- 2023-505070-15-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 62
- 18 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving any medications that are substrate of CYP3A4 or inducers and/ or inhibitors.
Other illness
- Have or any significant heart disease or condition.
Other
- Have tumors with known BRAF V600X, PTPN11 or KRAS Q61X mutations.
Who the study is looking for
- Part 1: Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDAC and BTC that has spread to other parts of the body and cannot be removed surgically, may or may not have received previous treatment with KRAS G12C inhibitors.
- Part 1: For NSCLC and CRC: Participants must have a documented KRAS G12C mutation from an approved test and when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory at the time of screening.
- Part 1: For PDAC and BTC: Participants must have a documented KRAS G12C mutation from an approved test.
- Part 1: Have failed, are intolerant or recurrence after available standard of care treatments.
- Part 2: Individuals must have a confirmed diagnosis of advanced KRAS G12C-mutant NSCLC (Part 2A) or CRC (Part 2B) that has spread to other parts of the body and cannot be removed surgically and are G12C inhibitors naive.
- Part 2: Participants must have a documented KRAS G12C mutation from an approved test and when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory at the time of screening.
- Part 2: Have failed, are intolerant or recurrence after at least 1 previous line of therapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Vall D'hebron Institut De Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| HUS Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| CHU De Bordeauxt Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Completed |
| Hopital Cardiologique Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Completed |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.