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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BioNTech SE
Study ID
NCT06841055
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pumitamig — DRUG
    Intravenous infusion
  • Docetaxel — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Mar 3, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A - Pumitamig Dose 1 + docetaxel
  • Experimental: Part 1B - Pumitamig Dose 2 + docetaxel
  • Experimental: Part 2: Selected doses of pumitamig + docetaxel
    Pumitamig and docetaxel will be administered at the dose level recommended by an internal review committee based on the observed safety profile from Part 1.

Primary Outcome Measure

Part 1 - Occurrence of dose limiting toxicities (DLTs) [ Time Frame: Up to 21 days after first dose of investigational medicinal product (IMP) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
The University of Alabama at Birmingham HospitalBirminghamAlabama35249-
Moffitt Cancer CenterTampaFlorida33612-
Baptist Health HardinElizabethtownKentucky42701-
NYU Langone - NYU Grossman School of MedicineNew YorkNew York10016-
Texas Oncology, P.A.HoustonTexas77090-

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
The University of Alabama at Birmingham Hospital· Birmingham, ALMoffitt Cancer Center· Tampa, FLBaptist Health Hardin· Elizabethtown, KYNYU Langone - NYU Grossman School of Medicine· New York, NYTexas Oncology, P.A.· Houston, TX

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