Recruiting
Phase 1
Phase 2

CR-002

Sponsor:

Crescent Biopharma, Inc.

Code:

NCT07909031

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)

Gastric/GEJ

Biliary Tract Cancer (BTC)

Esophageal Squamous Cell Carcinoma (ESCC)

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CR-002

Study Details

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)

Gastric/GEJ

Biliary Tract Cancer (BTC)

Esophageal Squamous Cell Carcinoma (ESCC)

Ovarian Cancer

Study ID

NCT07909031

Start date

Oct 21, 2026

Status verified date

Oct, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

219 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CR-002 Dose Escalation

Escalating dose levels of CR-002 will be tested to define the maximum tolerated dose of CR-002 in participants with locally advanced or metastatic solid tumors who are refractory to or unable to tolerate standard of care treatment, or for whom standard of care treatment is unavailable.

experimental: CR-002 Backfill

Escalating dose levels of CR-002 will be tested in indication-specific cohort populations.

Interventions

CR-002

Intravenous Infusion

Primary outcome measure

  • Part 1: Dose Escalation - incidence and nature of dose-limiting toxicities [ Time Frame: From the first dose of study drug up until approximately 1 month ]
  • Part 1: Dose Escalation - characterization of the maximum tolerated dose, if applicable [ Time Frame: From the first dose of study drug up until approximately 1 month ]
  • All Parts - incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events [ Time Frame: From the first dose of study drug until 90 days after the last dose of study drug ]
  • All Parts - incidence and severity of TEAEs leading to dose modifications [ Time Frame: From the first dose of study drug until 90 days after the last dose of study drug ]
  • All Parts - incidence and severity of TEAEs leading to treatment discontinuation [ Time Frame: From the first dose of study drug until 90 days after the last dose of study drug ]

Central Contacts and Locations

Central contacts

Crescent Clinical Trials

617-430-5595clinicaltrials@crescentbiopharma.com

Locations

Clinical Study Site

Recruiting

Austin, Texas, United States, 78758

Clinical Study Site

Recruiting

Dallas, Texas, United States, 75039

Clinical Study Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Crescent Biopharma, Inc.

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • Advanced Solid Tumors
  • Metastatic Solid Tumors
  • ADC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Crescent Biopharma, Inc. on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.