CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors (ASCEND)

A Phase 1/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 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-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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced / Metastatic Solid Tumors
• Intervention / Treatment: Drug: CR-001

Detailed Description

The study will initially comprise 3 parts: dose escalation, backfill, and dose optimization cohorts. The study will follow a stepwise approach, beginning with a typical dose escalation in participants with selected indications of advanced solid tumors. Additional participants will enroll in the backfill part at select dose levels that have been previously cleared for safety by the safety review committee. In dose optimization, participants will be randomized to one of two CR-001 dose levels.

All participants will undergo a screening period, a treatment period of up to 2 years, a safety follow-up period, and long-term efficacy and survival follow-up. During the treatment period, participants will undergo clinical and safety assessments including disease assessment scans and blood laboratory safety, pharmacokinetic, and pharmacodynamic assessments. After treatment ends, disease scans will continue until disease progression, and long-term follow-up visits will be conducted by telephone every 3 months.

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Crescent Clinical Trials; Phone Number: 617-430-5595; Email: clinicaltrials@crescentbiopharma.com

Study Locations

• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Clinical Study Site
• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 03080
      • Recruiting
      • Clinical Study Site
    • Seoul, Seoul, South Korea, 06351
      • Recruiting
      • Clinical Study Site
• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Clinical Study Site
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Clinical Study Site
    • Sarasota, Florida, United States, 34236
      • Recruiting
      • Clinical Study Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Clinical Study Site
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Clinical Study Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Clinical Study Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Clinical Study Site
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Clinical Study Site
  • Utah
    • West Valley City, Utah, United States, 84119
      • Recruiting
      • Clinical Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: CR-001; Intravenous Infusion
Experimental: CR-001 Backfill; Escalating dose levels of CR-001 Indication-specific cohort populations will be tested	Drug: CR-001; Intravenous Infusion
Experimental: CR-001 Dose Optimization Cohort X; monotherapy dose level (DL)-X Indication-specific cohort populations will be tested	Drug: CR-001; Intravenous Infusion
Experimental: CR-001 Dose Optimization Cohort Y; monotherapy DL-Y Indication-specific cohort populations will be tested	Drug: CR-001; Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation - Incidence and nature of dose-limiting toxicities	Per cohort	From the first dose of study drug up until approximately 1 month
Dose Escalation - Characterization of the maximum tolerated dose, if applicable	Per Cohort	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	Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)	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		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		From the first dose of study drug until 90 days after the last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All parts - Determination of recommended Phase 2 dose(s)		From the first dose of study drug until 90 days after the last dose of study drug
All parts - Serum CR-001 pharmacokinetic parameters	AUC0--inf after a single dose and steady state parameters, as appropriate	Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters	AUClast after a single dose and steady state parameters, as appropriate	Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters	Cmax after a single dose and steady state parameters, as appropriate	Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters	Tmax after a single dose and steady state parameters, as appropriate	Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters	Vd after a single dose and steady state parameters, as appropriate	Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters	CL after a single dose and steady state parameters, as appropriate	Predose until up to approximately 36 months
All parts - Serum CR-001 pharmacokinetic parameters	t½ after a single dose and steady state parameters, as appropriate	Predose until up to approximately 36 months
All parts - Incidence of participants with detectable antidrug antibodies		Predose until up to approximately 36 months
All parts - Overall response rate		From the first dose of study drug until up to approximately 36 months
All parts - Duration of response		From the first dose of study drug until up to approximately 36 months
All parts - Time to response		From the first dose of study drug until up to approximately 36 months
All parts - Progression free survival		From the first dose of study drug until up to approximately 36 months
All parts - Overall survival		From the first dose of study drug until up to approximately 36 months
All parts - Best percent change in target lesions		From the first dose of study drug until up to approximately 36 months

Collaborators and Investigators

• Sponsor: Crescent Biopharma, Inc.
• Investigators: Study Director: Brad Sumrow, MD, Crescent Biopharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: First-in-Human; VEGF; metastatic cancer; PD-1; solid tumors; metastatic; advanced cancer; checkpoint inhibitor; immuno-oncology; anti-PD-1; Dose Escalation; anti-angiogenic therapy; anti VEGF; Dose Optimization
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: CR-001-101; 2025-523590-42-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No