Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies.

Official Title

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications

Details

BBI-355 is administered orally in various dosing schedules to subjects with locally advanced or metastatic non-resectable solid tumors harboring oncogene amplifications, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.

Keywords

Non-small Cell Lung Cancer, Non-Small Cell Lung Adenocarcinoma, Non-Small Cell Squamous Lung Cancer, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer, Gastric Cancer, Breast Cancer, Bladder Cancer, Ovarian Cancer, Endometrial Cancer, Liposarcoma, ecDNA, extrachromosomal DNA, Amplification, Oncogene Amplification, Checkpoint kinase 1, CHK1, EGFR amplification, FGFR1 amplification, FGFR2 amplification, FGFR3 amplification, Lung Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Adenocarcinoma of Lung, Erlotinib Hydrochloride, Futibatinib, BBI-355, Erlotinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists,
  • Single agent arm: Evidence of oncogene amplification,
  • BBI-355 combination with erlotinib arm: Evidence of amplification of wildtype EGFR,
  • BBI-355 combination with futibatinib arm: Evidence of amplification of wildtype FGFR1, FGFR2, FGFR3, or FGFR4,
  • Availability of FFPE tumor tissue, archival or newly obtained,
  • Measurable disease as defined by RECIST Version 1.1,
  • Adequate hematologic function,
  • Adequate hepatic and renal function,
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,
  • Other inclusion criteria per study protocol.

You CAN'T join if...

  • Well-known tumor activating oncogene mutations or fusions,
  • Prior exposure to CHK1 inhibitors,
  • BBI-355 combination with erlotinib arm: Prior exposure to EGFR inhibitors,
  • BBI-355 combination with futibatinib arm: Prior exposure to FGFR inhibitors,
  • Hematologic malignancies,
  • Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,
  • Prior or concurrent malignancies, with exceptions per study protocol,
  • History of HBV, HCV, or HIV infection,
  • Clinically significant cardiac condition,
  • Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,
  • QTcF > 470 msec,
  • Prior organ allograft transplantations or allogeneic peripheral blood stem cell/bone marrow transplantation,
  • Other exclusion criteria per study protocol.

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Sarcoma Oncology accepting new patients
    Santa Monica California 90403 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boundless Bio
ID
NCT05827614
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated