Recruiting
Phase 1
Phase 2

CR-001

Sponsor:

Crescent Biopharma, Inc.

Code:

NCT07335497

Conditions

Locally Advanced / Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CR-001

Study Details

Brief summary:

The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and/or optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.

Conditions

Locally Advanced / Metastatic Solid Tumors

Study ID

NCT07335497

Start date

Feb 17, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key 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
  • For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy
  • Tumor Indication specific inclusion criteria:
  • For dose escalation or backfill: 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:

  • Hepatocellular carcinoma
  • Biliary tract cancer
  • Endometrial carcinoma
  • Cervical cancer
  • Ovarian cancer
  • Gastric or gastroesophageal cancer
  • Colorectal cancer
  • Non-small cell lung cancer

Key Exclusion Criteria

  • Has malignancies other than disease under study within the past 3 years
  • Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy
  • Has not adequately recovered from recent major surgery
  • Has ongoing clinically significant toxicity related to prior therapy
  • Has active central nervous system (CNS) metastases
  • Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)
  • Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)
  • Has a history of noninfectious pneumonitis/interstitial lung disease
  • Has an active severe infection
  • Has received a live or attenuated vaccine within 30 days of the first dose
  • Has undergone prior allogeneic stem cell or solid organ transplantation
  • Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding
  • Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.

Study Design

Enrollment

290 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CR-001 Dose escalation

Escalating dose levels of CR-001 to define the maximum tolerated dose of CR-001 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-001 Backfill

Escalating dose levels of CR-001 Indication-specific cohort populations will be tested

experimental: CR-001 Dose Optimization Cohort X

monotherapy dose level (DL)-X Indication-specific cohort populations will be tested

experimental: CR-001 Dose Optimization Cohort Y

monotherapy DL-Y Indication-specific cohort populations will be tested

Interventions

CR-001

Intravenous Infusion

Primary outcome measure

  • Dose Escalation - Incidence and nature of dose-limiting toxicities [ Time Frame: From the first dose of study drug up until approximately 1 month ]
  • 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

Birmingham, Alabama, United States, 35294

Clinical Study Site

Recruiting

Los Angeles, California, United States, 90033

Clinical Study Site

Recruiting

Denver, Colorado, United States, 80218

Clinical Study Site

Recruiting

Washington D.C., District of Columbia, United States, 20009

Clinical Study Site

Recruiting

Orlando, Florida, United States, 32827

Clinical Study Site

Recruiting

Sarasota, Florida, United States, 34236

Clinical Study Site

Recruiting

Detroit, Michigan, United States, 48201

Clinical Study Site

Recruiting

Grand Rapids, Michigan, United States, 49546

Clinical Study Site

Recruiting

New York, New York, United States, 10029

Clinical Study Site

Recruiting

Columbus, Ohio, United States, 43210

Clinical Study Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Clinical Study Site

Recruiting

Nashville, Tennessee, United States, 37203

Clinical Study Site

Recruiting

Dallas, Texas, United States, 75230

Clinical Study Site

Recruiting

San Antonio, Texas, United States, 78229

Clinical Study Site

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Crescent Biopharma, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • solid tumors
  • metastatic
  • VEGF
  • PD-1
  • anti-PD-1
  • anti VEGF
  • immuno-oncology
  • anti-angiogenic therapy
  • checkpoint inhibitor
  • metastatic cancer
  • advanced cancer
  • First-in-Human
  • Dose Escalation
  • Dose Optimization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Crescent Biopharma, Inc. on 2026-09-01.