NCT07909031RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 219 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 21 Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Crescent Biopharma, Inc.
- Diseases
- Head and neck cancer, Endometrial cancer, Cervical cancer, Lung cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07909031
- EU CT number
- 2026-527289-54-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 219
- From 21 Oct 2026 to the primary completion date, Oct 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has not adequately recovered from recent major surgery
- Has ongoing clinically significant toxicity related to prior therapy
- Has received prior treatment with an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload.
Other illness
- Has malignancies other than disease under study within the past 3 years
- Has a medical or psychological condition that could interfere with study participation, increase risk, or affect interpretation of the study results
Other
- Has known sensitivity to any component of CR-002
- Has active central nervous system (CNS) metastases
- NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.