A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)
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.
Detailed description
If the dose level (either from Part 1A or 1B) seems tolerable, an internal review committee will decide if the study can proceed to Part 2 and enroll additional participants. In Part 2, participants who consent will be included in a separate cohort in which they will receive the same treatment as the other participants in Part 2, but in addition to a fresh baseline tumor biopsy, they will be required to provide an on-treatment tumor biopsy sample for additional analyses. Study participants will receive pumitamig in combination with docetaxel until disease progression, the occurrence of intolerable toxicity, study participant withdrawal, death, study termination or 2-year limit (whichever comes first). After completion of study treatment, except for participants who withdraw informed consent, a long-term follow-up will be conducted for all participants to record disease progression, subsequent new anticancer treatments, and survival status.
Arms & interventions
- DrugPumitamig
Intravenous infusion
- DrugDocetaxel
Intravenous infusion
Outcome measures
Primary
Part 1 - Occurrence of dose limiting toxicities (DLTs)
During the DLT evaluation period by dose level
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: Up to approximately 2 years
Secondary
Part 1 and Part 2 - Duration of Response
Time frame: Up to approximately 2 years
Part 1 and Part 2- Progression-free Survival
Time frame: Up to approximately 2 years
Part 1 and Part 2 - Depth of Response
Time frame: Up to approximately 2 years
Part 1 and Part 2 - Disease Control Rate
Time frame: Up to approximately 2 years
Part 1 and Part 2 - Time to Response
Time frame: Up to approximately 2 years
Part 1 and Part 2 - Overall Survival
Time frame: Up to approximately 2 years
Part 1 and Part 2 - Pharmacokinetic assessment: Maximum concentration (Cmax) derived from serum concentration of pumitamig
Time frame: From pre-dose to the end of study treatment (up to approximately 2 years)
Part 1 and Part 2 - Number of participants developing detectable anti-pumitamig antibodies in serum
Time frame: From pre-dose to the end of study treatment (up to approximately 2 years)
Eligibility criteria
Study locations (5)
The University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249
Moffitt Cancer Center
Tampa, Florida, 33612
Baptist Health Hardin
Elizabethtown, Kentucky, 42701
NYU Langone - NYU Grossman School of Medicine
New York, New York, 10016
Texas Oncology, P.A.
Houston, Texas, 77090