CR-001 treatment for adults with advanced or metastatic solid tumors
A Phase 1/2, 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
PHASE1; PHASE2 · Crescent Biopharma, Inc. · NCT07335497
This trial will try CR-001 as a treatment for adults with advanced or metastatic solid tumors to find safe and recommended dose levels.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Crescent Biopharma, Inc. (industry) |
| Locations | 10 sites (Denver, Colorado and 9 other locations) |
| Trial ID | NCT07335497 on ClinicalTrials.gov |
What this trial studies
The trial tests CR-001 as a monotherapy in adults with locally advanced or metastatic solid tumors through Phase 1 dose-finding and Phase 2 dose optimization stages. It begins with dose escalation to identify the maximum tolerated or optimal biologic dose, includes backfill cohorts at dose levels cleared for safety, and then randomizes participants in dose optimization to one of two CR-001 dose levels. Participants receive up to two years of treatment with regular safety labs, pharmacokinetic and pharmacodynamic sampling, and disease assessment scans, with scans continuing after treatment until disease progression. Long-term efficacy and survival follow-up are conducted by telephone every three months.
Who should consider this trial
Good fit: Adults with measurable locally advanced or metastatic solid tumors (for example hepatocellular carcinoma, biliary tract, endometrial, cervical, ovarian, gastric/gastroesophageal, colorectal, or non-small cell lung cancer), ECOG 0–1, life expectancy ≥3 months, adequate organ function, and who are progressing on or ineligible for standard therapies are ideal candidates.
Not a fit: Patients with poor performance status (ECOG ≥2), life expectancy under three months, inadequate organ function, other active malignancies within the past three years, or contraindications to required procedures are unlikely to benefit.
Why it matters
Potential benefit: If successful, CR-001 could provide a new treatment option with an acceptable safety profile for patients whose advanced solid tumors have progressed on or are unsuitable for standard therapies.
How similar studies have performed: Other therapies targeting PD-1 and VEGF pathways have shown benefit in several tumor types, but CR-001 as a monotherapy in this early-phase setting is novel and has not yet shown proven clinical benefit.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Denver, Colorado and 9 other locations
- Clinical Study Site — Denver, Colorado, United States (RECRUITING)
- Clinical Study Site — Orlando, Florida, United States (RECRUITING)
- Clinical Study Site — Sarasota, Florida, United States (RECRUITING)
- Clinical Study Site — Grand Rapids, Michigan, United States (RECRUITING)
- Clinical Study Site — Columbus, Ohio, United States (RECRUITING)
- Clinical Study Site — Nashville, Tennessee, United States (RECRUITING)
- Clinical Study Site — Dallas, Texas, United States (RECRUITING)
- Clinical Study Site — San Antonio, Texas, United States (RECRUITING)
- Clinical Study Site — West Valley City, Utah, United States (RECRUITING)
- Clinical Study Site — South Brisbane, Queensland, Australia (RECRUITING)
Study contacts
- Study coordinator: Crescent Clinical Trials
- Email: clinicaltrials@crescentbiopharma.com
- Phone: 617-430-5595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced / Metastatic Solid Tumors, solid tumors, metastatic, VEGF, PD-1, anti-PD-1, anti VEGF, immuno-oncology