Clinical Trial 22068

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT05375084

Phase: Phase I
Principal Investigator: Pellini, Bruna

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Overview

Study Title

A Phase 1 Study of the SHP2 Inhibitor BBP-398 (formerly known as IACS-15509) in Combination with the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer with a KRAS Mutation

Summary

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with nivolumab, a PD-1 antibody, in patients with NSCLC with a KRAS mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion.

Objective

Primary Objective * To evaluate the safety, tolerability, and RP2D of BBP-398, a SHP2 inhibitor, when used in combination with nivolumab in patients with advanced NSCLC with a KRAS mutation who have failed standard of care treatment. 3.1.2 Secondary Objectives * Assess preliminary antitumor activity of BBP-398 in combination with nivolumab (as defined by objective response rate [ORR, complete response (CR) + partial response (PR) rate], duration of response [DOR], and progression free survival [PFS] according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and as assessed by investigator, and overall survival [OS]) * Characterize the pharmacokinetics (PK) of BBP-398 and nivolumab given in combination * Characterize circulating and intratumoral target engagement (pharmacodynamic activity) of BBP-398 in combination with nivolumab * Characterize the immunogenicity of nivolumab when given in combination with BBP-398

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

BBP-398 (); BMS-936558 (Nivolumab); Nivolumab (Opdivo)

Inclusion Criteria

Patients must have histologically documented, locally advanced and unresectable, or metastatic NSCLC with documentation of a KRAS mutation within the 1 year prior to screening.

Patients must have measurable disease by RECIST v1.1.

Patients must have a minimum life expectancy of >12 weeks after start of study treatment.

Patients must have progression or disease recurrence on or after at least one prior line of systemic therapy, which must include platinum-based doublet chemotherapy and anti-PD-(L)1 therapy.

Patients must have experienced progressive or recurrent disease occurring either during treatment or within 90 days after discontinuing anti-PD-(L)1 therapy.

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Patients must have adequate organ function.

Exclusion Criteria

Patients that have participated in an interventional clinical study within the last 4 weeks.

Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment.

Patients with known central nervous system (CNS) tumors or active CNS metastases.

Patients that have experienced progressive disease (PD) within the first 120 days of initiating treatment with an anti- PD-(L)1 agent (e.g., primary refractory).

Patients that have a history of allogenic bone marrow transplant.

Patients that have select known or suspected autoimmune disease.

Patients that have a condition requiring systemic treatment with either corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive medication within 14 days of study start.

Patients that have received any live/attenuated vaccine within 30 days of first study treatment.

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