NCT07335497 CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT07335497 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Crescent Biopharma, Inc. |
| Condition | Locally Advanced / Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 290 participants in total. It began in 2026-02-17 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Brad Sumrow, MD
STUDY DIRECTOR
Crescent Biopharma, Inc.
Frequently Asked Questions
Who can join the NCT07335497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced / Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07335497 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07335497 currently recruiting?
Yes, NCT07335497 is actively recruiting participants. Contact the research team at clinicaltrials@crescentbiopharma.com for enrollment information.
Where is the NCT07335497 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Denver, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT07335497 clinical trial?
NCT07335497 is sponsored by Crescent Biopharma, Inc.. The principal investigator is Brad Sumrow, MD at Crescent Biopharma, Inc.. The trial plans to enroll 290 participants.