CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Key Inclusion Criteria

• Life expectancy ≥ 3 months

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1

• Adequate organ function and hematologic reserve based on laboratory parameters

• Have measurable disease defined by RECIST v1.1

• For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy

• Tumor Indication specific inclusion criteria:

• For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types:

• Hepatocellular carcinoma

• Biliary tract cancer

• Endometrial carcinoma

• Cervical cancer

• Ovarian cancer

• Gastric or gastroesophageal cancer

• Colorectal cancer

• Non-small cell lung cancer

Key Exclusion Criteria

• Has malignancies other than disease under study within the past 3 years

• Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy

• Has not adequately recovered from recent major surgery

• Has ongoing clinically significant toxicity related to prior therapy

• Has active central nervous system (CNS) metastases

• Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)

• Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)

• Has a history of noninfectious pneumonitis/interstitial lung disease

• Has an active severe infection

• Has received a live or attenuated vaccine within 30 days of the first dose

• Has undergone prior allogeneic stem cell or solid organ transplantation

• Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding

• Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.