CR-002 study in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a dose-escalation design to identify the maximum tolerated dose and optimal biologic dose of CR-002, followed by dose backfill and population-defined optimization with potential expansion cohorts. It includes screening, treatment, safety follow-up, and long-term follow-up, with regular disease assessments and pharmacokinetic monitoring. Participants must have measurable disease and meet tumor-type-specific criteria, and may provide archival tissue or undergo a biopsy. Enrollment is in multiple parts with possible additional cohorts based on safety and emerging data.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Study Site
  Austin, Texas, United States Recruiting
• Clinical Study Site
  Dallas, Texas, United States Recruiting
• Clinical Study Site
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Crescent Clinical Trials
• Email: clinicaltrials@crescentbiopharma.com
• Phone: 617-430-5595

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.