Tests CR-002 in adults with advanced solid tumors
Tests the safety of CR-002 in adults with several advanced solid cancers.
Plain-language title generated from the registry record
Registry title: CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Key facts
- Where
- Austin, Dallas, and Fairfax, United StatesSee the 3 sites
- Phase
- Phase 1/2
Where in United States
- AustinAustin, United StatesTaking people
- DallasDallas, United StatesTaking people
- FairfaxFairfax, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Crescent Biopharma, Inc.
- Trial code
- NCT07909031EU 2026-527289-54-00
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; 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.