Brief Title: Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 1 - Timeframe: 28 days following first administration of CPI-444

Primary Outcome 2 - Measure: Objective response rate per RECIST v1.1 criteria of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 2 - Timeframe: From start of treatment to end of treatment, up to 36 months

Primary Outcome 3 - Measure: Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 3 - Timeframe: Continuously, up to 36 months

Primary Outcome 4 - Measure: Mean and median Area under the curve (AUC) of CPI-444

Primary Outcome 4 - Timeframe: Day 14 of Cycle 1

Primary Outcome 5 - Measure: Mean and median Maximum concentration (Cmax) of CPI-444

Primary Outcome 5 - Timeframe: Day 14 of Cycle 1

Primary Outcome 6 - Measure: Identify the MDL (maximum dose level) of single agent CPI-444

Primary Outcome 6 - Timeframe: From start of treatment to end of treatment, up to 36 months.

CONDITION

• Non-Small Cell Lung Cancer
• Malignant Melanoma
• Renal Cell Cancer
• Triple Negative Breast Cancer
• Colorectal Cancer
• Bladder Cancer
• Metastatic Castration Resistant Prostate Cancer

ELIGIBILITY

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: C Clark

Role: Study Director

Affiliation: Corvus Pharmaceuticals

Overall Contact

Name: C Clark

Phone: 650-900-4520

Email: inquiry@corvuspharma.com

LOCATION