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

Summary

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.

Eligibility

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.

Conditions2

Locations5 sites

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