Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
Pumitamig: Intravenous infusion
Docetaxel: Intravenous infusion
Study summary
This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care.
Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially.
Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.
Eligibility
Primary outcome measure(s)
- Part 1 - Occurrence of dose limiting toxicities (DLTs) — Up to 21 days after first dose of investigational medicinal product (IMP)
During the DLT evaluation period by dose level - Part 1 and Part 2 - Occurrence of pumitamig treatment emergent adverse events, treatment-related adverse events, treatment emergent serious adverse events, treatment-related serious adverse events, and adverse events of special interest — From initiation of the first dose of IMP to the 90-day Follow-Up visit
Graded according to the (United States) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) - Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and/or participant discontinuation due to adverse events — From initiation of the first dose of IMP until the 90-day Safety Follow-up visit
- Part 1 and Part 2 - Objective response rate — Up to approximately 2 years
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) based on investigator's review) is observed as best overall response.
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Alabama at Birmingham Hospital | Birmingham | Alabama | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Baptist Health Hardin | Elizabethtown | Kentucky | Recruiting |
| NYU Langone - NYU Grossman School of Medicine | New York | New York | Recruiting |
| Texas Oncology, P.A. | Houston | Texas | Completed |
| Liverpool Cancer Therapy Centre | Liverpool | New South Wales | Recruiting |
| Metro South Health - Princess Alexandra Hospital (PAH) | Woolloongabba | Queensland | Recruiting |
| Cancer Research SA (CRSA) | Adelaide | South Austraila | Recruiting |
| Hobart Hospital-Royal Hobart Hospital | Hobart | Tasmania | Recruiting |
| One Clinical Research - Hollywood Private Hospital | Nedlands | Western Australia | Recruiting |
| Gyeongsang National University Hospital (GNUH) | Jinju | Gyeongsangnam-do | Recruiting |
| Chungbuk National University Hospital | Cheongju-si | South Korea | Recruiting |
| Gachon University Gil Medical Center | Incheon | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Institut dInvestigacio Biomedica de Bellvitge (IDIBELL) | Barcelona | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio | Seville | Spain | Recruiting |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) | Valencia | Spain | Recruiting |
| Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus | Adana | Turkey (Türkiye) | Recruiting |
| Memorial Ankara Hospital | Ankara | Turkey (Türkiye) | Recruiting |
| Ankara Bilkent City Hospital | Ankara | Turkey (Türkiye) | Recruiting |
| Memorial Antalya Hospital | Antalya | Turkey (Türkiye) | Recruiting |
| Yeditepe University Hospital | Istanbul | Turkey (Türkiye) | Recruiting |
| Koc Universitesi Hastanesi (Koc University Hospital) | Zeytinburnu | Turkey (Türkiye) | Recruiting |
| Velindre NHS Trust, Velindre Cancer Centre | Cardiff | United Kingdom | Recruiting |
| St James's University Hospital - Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom | Recruiting |
| Sarah Cannon Research Institute | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust | Manchester | United Kingdom | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06841055 on ClinicalTrials.gov ↗ ← All trials in Spain