- CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors — Recruiting • Phase I • Oncology • NCT07335497.
- CR-001 monotherapy is being evaluated for safety, tolerability, and dose optimization (MTD/RP2D) in adults with locally advanced or metastatic solid tumors, representing early-stage clinical investigation of a novel therapeutic agent.
- Eligible participants are adults with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have exhausted standard treatment options or are unsuitable for conventional therapy, ensuring appropriate study population enrichment.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.