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Clinical Trial 22068

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

Phase: Phase I
Principal Investigator: Pellini, Bruna

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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


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.


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



Chemotherapy (NOS); Immunotherapy


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.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.