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 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: BNT327-072024-518279-80-00
• Study Type: interventional
• Target: 60
• Locations: 6 countries
• Sites: 30

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Second-line treatment; Immunotherapy; Combination with other investigational agents; Bispecific antibody; Vascular endothelial growth factor (VEGF) A; Programmed death-ligand 1 (PD-L1); Combination with chemotherapy

Outcome Measures

Primary Outcomes (4)

• Part 1 - Occurrence of dose limiting toxicities (DLTs)

  During the DLT evaluation period by dose level

  Up to 21 days after first dose of investigational medicinal product (IMP)

• 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

  Graded according to the (United States) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)

  From initiation of the first dose of IMP to the 90-day Follow-Up visit

• 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

  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.

  Up to approximately 2 years

Secondary Outcomes (8)

• Part 1 and Part 2 - Duration of Response

  Up to approximately 2 years

• Part 1 and Part 2- Progression-free Survival

  Up to approximately 2 years

• Part 1 and Part 2 - Depth of Response

  Up to approximately 2 years

• Part 1 and Part 2 - Disease Control Rate

  Up to approximately 2 years

• Part 1 and Part 2 - Time to Response

  Up to approximately 2 years

Study Arms (3)

Part 1A - Pumitamig Dose 1 + docetaxel

EXPERIMENTAL

Drug: Pumitamig; Drug: Docetaxel

Part 1B - Pumitamig Dose 2 + docetaxel

EXPERIMENTAL

Drug: Pumitamig; Drug: Docetaxel

Part 2: Selected doses of pumitamig + docetaxel

EXPERIMENTAL

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.

Drug: Pumitamig; Drug: Docetaxel

Interventions

Pumitamig DRUG

Intravenous infusion

Also known as: BNT327, PM8002, BMS-986545

Part 1A - Pumitamig Dose 1 + docetaxel; Part 1B - Pumitamig Dose 2 + docetaxel; Part 2: Selected doses of pumitamig + docetaxel

Docetaxel DRUG

Intravenous infusion

Part 1A - Pumitamig Dose 1 + docetaxel; Part 1B - Pumitamig Dose 2 + docetaxel; Part 2: Selected doses of pumitamig + docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNTech SE: lead
• BioNTech (Shanghai) Pharmaceuticals Co., Ltd.: collaborator

Study Sites (30)

The University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35249, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Baptist Health Hardin

Elizabethtown, Kentucky, 42701, United States

RECRUITING

NYU Langone - NYU Grossman School of Medicine

New York, New York, 10016, United States

RECRUITING

Texas Oncology, P.A.

Houston, Texas, 77090, United States

COMPLETED

Liverpool Cancer Therapy Centre

Liverpool, New South Wales, 2170, Australia

RECRUITING

Metro South Health - Princess Alexandra Hospital (PAH)

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Cancer Research SA (CRSA)

Adelaide, South Austraila, 5000, Australia

RECRUITING

Hobart Hospital-Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

One Clinical Research - Hollywood Private Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

Gyeongsang National University Hospital (GNUH)

Jinju, Gyeongsangnam-do, 52727, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)

Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, 46026, Spain

RECRUITING

Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus

Adana, 01250, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hospital

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Memorial Antalya Hospital

Antalya, 07090, Turkey (Türkiye)

RECRUITING

Yeditepe University Hospital

Istanbul, 34752, Turkey (Türkiye)

RECRUITING

Koc Universitesi Hastanesi (Koc University Hospital)

Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

Velindre NHS Trust, Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

RECRUITING

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 24, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); KR (5); US (5); AU (5); ES (5); TU (6)