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

RecruitingPhase 1, Phase 2

Sponsor: Crescent Biopharma, Inc.

Conditions: Locally Advanced / Metastatic Solid Tumors

Interventions: CR-001

Countries: United States, Australia, Ireland, Italy, Romania, South Korea, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (31)

Birmingham, Alabama, United States
Los Angeles, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
New York, New York, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
West Valley City, Utah, United States
South Brisbane, Queensland, Australia
Dublin, Ireland, Ireland
Milan, Milano, Italy
Candiolo, Torino, Italy
Cluj-Napoca, Cluj, Romania
Bucharest, Romania
Seoul, Seoul, South Korea
Seoul, Seoul, South Korea
Seoul, Seoul, South Korea
Songpa-dong, Seoul, South Korea
Seongnam-si, South Korea
Barcelona, Barcelona, Spain
Logroño, La Rioja, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
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