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

A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.

The study will initially comprise 3 parts: dose escalation, backfill, and dose optimization cohorts. The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors. Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee. In dose optimization, participants will be randomized to one of two CR-001 dose levels.

All participants will undergo a screening period, a treatment period of up to 2 years, a safety follow-up period, and long-term efficacy and survival follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, pharmacokinetic, and pharmacodynamic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.

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.