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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose Escalation - Incidence and nature of dose-limiting toxicities — From the first dose of study drug up until approximately 1 month Per cohort
Dose Escalation - Characterization of the maximum tolerated dose, if applicable — From the first dose of study drug up until approximately 1 month Per Cohort
All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse events — From the first dose of study drug until 90 days after the last dose of study drug Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
All parts - Incidence and severity of TEAEs leading to dose modifications — From the first dose of study drug until 90 days after the last dose of study drug
All parts - Incidence and severity of TEAEs leading to treatment discontinuation — From the first dose of study drug until 90 days after the last dose of study drug
Trial sites (31)
Facility
City
Region
Status
Clinical Study Site
Birmingham
Alabama
Recruiting
Clinical Study Site
Los Angeles
California
Recruiting
Clinical Study Site
Denver
Colorado
Recruiting
Clinical Study Site
Washington D.C.
District of Columbia
Recruiting
Clinical Study Site
Orlando
Florida
Recruiting
Clinical Study Site
Sarasota
Florida
Recruiting
Clinical Study Site
Detroit
Michigan
Recruiting
Clinical Study Site
Grand Rapids
Michigan
Recruiting
Clinical Study Site
New York
New York
Recruiting
Clinical Study Site
Columbus
Ohio
Recruiting
Clinical Study Site
Pittsburgh
Pennsylvania
Recruiting
Clinical Study Site
Nashville
Tennessee
Recruiting
Clinical Study Site
Dallas
Texas
Recruiting
Clinical Study Site
San Antonio
Texas
Recruiting
Clinical Study Site
West Valley City
Utah
Recruiting
Clinical Study Site
South Brisbane
Queensland
Withdrawn
Clinical Study Site
Dublin
Ireland
Recruiting
Clinical Study Site
Milan
Milano
Recruiting
Clinical Study Site
Candiolo
Torino
Recruiting
Clinical Study Site
Cluj-Napoca
Cluj
Recruiting
Clinical Study Site
Bucharest
Romania
Recruiting
Clinical Study Site
Seoul
Seoul
Recruiting
Clinical Study Site
Seoul
Seoul
Recruiting
Clinical Study Site
Seoul
Seoul
Recruiting
Clinical Study Site
Songpa-dong
Seoul
Recruiting
Clinical Study Site
Seongnam-si
South Korea
Recruiting
Clinical Study Site
Barcelona
Barcelona
Recruiting
Clinical Study Site
Logroño
La Rioja
Recruiting
Clinical Study Site
Madrid
Madrid
Recruiting
Clinical Study Site
Madrid
Madrid
Recruiting
Clinical Study Site
Manchester
Greater Manchester
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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