NCT07335497

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for phase_1

Timeline
33mo left

Started Feb 2026

Typical duration for phase_1

Geographic Reach
2 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Feb 2029

First Submitted

Initial submission to the registry

January 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 17, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

January 8, 2026

Last Update Submit

May 4, 2026

Conditions

Locally Advanced / Metastatic Solid Tumors

Keywords

solid tumorsmetastaticVEGFPD-1anti-PD-1anti VEGFimmuno-oncologyanti-angiogenic therapycheckpoint inhibitormetastatic canceradvanced cancerFirst-in-HumanDose EscalationDose Optimization

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (15)

  • 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

    Predose until up to approximately 36 months

  • All parts - Serum CR-001 pharmacokinetic parameters

    Predose until up to approximately 36 months

  • All parts - Serum CR-001 pharmacokinetic parameters

    Predose until up to approximately 36 months

  • All parts - Serum CR-001 pharmacokinetic parameters

    Predose until up to approximately 36 months

  • +10 more secondary outcomes

Study Arms (4)

CR-001 Dose escalation

EXPERIMENTAL

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

CR-001 Backfill

EXPERIMENTAL

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

Drug: CR-001

CR-001 Dose Optimization Cohort X

EXPERIMENTAL

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

Drug: CR-001

CR-001 Dose Optimization Cohort Y

EXPERIMENTAL

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

Drug: CR-001

Interventions

CR-001DRUG

Intravenous Infusion

CR-001 BackfillCR-001 Dose Optimization Cohort XCR-001 Dose Optimization Cohort YCR-001 Dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Clinical Study Site

Denver, Colorado, 80218, United States

RECRUITING

Clinical Study Site

Orlando, Florida, 32827, United States

RECRUITING

Clinical Study Site

Sarasota, Florida, 34236, United States

RECRUITING

Clinical Study Site

Grand Rapids, Michigan, 49546, United States

RECRUITING

Clinical Study Site

Columbus, Ohio, 43210, United States

RECRUITING

Clinical Study Site

Nashville, Tennessee, 37203, United States

RECRUITING

Clinical Study Site

Dallas, Texas, 75230, United States

RECRUITING

Clinical Study Site

San Antonio, Texas, 78229, United States

RECRUITING

Clinical Study Site

West Valley City, Utah, 84119, United States

RECRUITING

Clinical Study Site

South Brisbane, Queensland, 4101, Australia

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brad Sumrow, MD

    Crescent Biopharma, Inc.

    STUDY DIRECTOR

Central Study Contacts

Crescent Clinical Trials

CONTACT

617-430-5595clinicaltrials@crescentbiopharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 13, 2026

Study Start

February 17, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations

AU(1)US(9)