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RecruitingPhase 1 / Phase 2NCT07909031
Official study title

CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCR-002

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Crescent Biopharma, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Crescent Biopharma, Inc.
Interventions being studied
Drug: CR-002
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Clinical Study SiteAustin, Texas
  • Clinical Study SiteDallas, Texas
  • Clinical Study SiteFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 2, 2026. Always confirm current availability with the study team.

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