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Recruiting Phase 2

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

NCT06841055 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-03-03
Last updated
2026-04-24

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pumitamig →Docetaxel →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \[PD-1\]/ programmed death ligand-1 \[PD-L1\] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 9th edition. * Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study. * Only one prior line of immunotherapy containing regimen is allowed in an advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months. * Historical PD-L1 results must be available. * Participants with actionable genetic alterations may be enrolled if they received locally approved and available targeted agent in combination with immunotherapy in first-line advanced/metastatic setting. * Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be kept below 30% in the overall study population. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator. * Participants must provide tumor tissue samples obtained ≤18 months prior to enrollment. For the additional cohort in Part 2, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required. * Eastern cooperative oncology group performance status of 0 or 1. * Adequate organ function as defined in the protocol. Key Exclusion Criteria: * Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label). * Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents. * Have received more than one prior lines of therapies in advanced/metastatic setting. * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. * Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy. * Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of study treatment. * Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Participants with significant risk of hemorrhage as defined in the protocol. * Have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

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)

FacilityCityRegionStatus
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
Official registry record

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