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CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Trial Status: active
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07335497.
Locations matching your search criteria
United States
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Approved
Name Not Available
New York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
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
