NCT07909031 CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT07909031 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Crescent Biopharma, Inc. |
| Condition | Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M) |
| Study Type | INTERVENTIONAL |
| Enrollment | 219 participants |
| Start Date | 2026-10-21 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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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 219 participants in total. It began in 2026-10-21 with a primary completion date of 2028-10.
⚠ 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-002 and to identify the MTD and/or optimal biologic dose and RP2D(s) in participants with locally advanced or metastatic solid tumors.
Eligibility Criteria
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 * Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy * Tumor indication specific inclusion criteria: * Is 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: * Head and Neck Squamous Cell Carcinoma (HNSCC) * Gastric/GEJ Cancer * Biliary Tract Cancer (BTC) * Esophageal Squamous Cell Carcinoma (ESCC) * Ovarian Cancer * Endometrial Carcinoma * Cervical Cancer * Non-Small Cell Lung Cancer (NSCLC) Exclusion Criteria: * Has malignancies other than disease under study within the past 3 years * Has not adequately recovered from recent major surgery * Has ongoing clinically significant toxicity related to prior therapy * Has known sensitivity to any component of CR-002 * Has received prior treatment with an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload. * Has active central nervous system (CNS) metastases * Has a medical or psychological condition that could interfere with study participation, increase risk, or affect interpretation of the study results * NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07909031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M). 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 NCT07909031 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 NCT07909031 currently recruiting?
Yes, NCT07909031 is actively recruiting participants. Contact the research team at clinicaltrials@crescentbiopharma.com for enrollment information.
Where is the NCT07909031 trial being conducted?
This trial is being conducted at Austin, United States, Dallas, United States, Fairfax, United States.
Who is sponsoring the NCT07909031 clinical trial?
NCT07909031 is sponsored by Crescent Biopharma, Inc.. The trial plans to enroll 219 participants.