Brief Title: Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy, in Subjects With Tumors With Oncogene Amplifications

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355

Primary Outcome 1 - Timeframe: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)

Primary Outcome 2 - Measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-355

Primary Outcome 2 - Timeframe: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)

CONDITION

• 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

ELIGIBILITY

Key Inclusion Criteria:
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,

- Evidence of oncogene amplification,

- 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.
Key Exclusion Criteria:
Prior exposure to CHK1 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Klaus Wagner, MD, PhD

Role: Study Director

Affiliation: Boundless Bio

Overall Contact

Name: Klaus Wagner, MD, PhD

Phone: 16198211090, 16198211090

Email: ClinicalDevelopment@boundlessbio.com, ClinicalDevelopment@boundlessbio.com

LOCATION