A Phase I/II, 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

Study Identifier:
CR-001-101
CT.gov Identifier:
NCT07335497
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-523590-42-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: CR-001 Backfill
    • Read More
  • Drug: Escalating dose levels of CR-001 Indication-specific cohort populations will be tested
  • Drug: Drug: CR-001
  • Drug: Intravenous Infusion
  • Drug: EXPERIMENTAL: CR-001 Dose escalation
  • Drug: Escalating dose levels of CR-001 to define the maximum tolerated dose of CR-001 in participants with locally advanced or metastatic solid tumors who are refractory to or unable to tolerate standard of care treatment, or for whom standard of care treatment is unavailable
  • Drug: EXPERIMENTAL: CR-001 Dose Optimization Cohort X
  • Drug: monotherapy dose level (DL)-X Indication-specific cohort populations will be tested
  • Drug: EXPERIMENTAL: CR-001 Dose Optimization Cohort Y
  • Drug: monotherapy DL-Y Indication-specific cohort populations will be tested
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • 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
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor