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CR-001 for Locally Advanced or Metastatic Solid Tumors

This study is testing a drug called CR-001 given through an IV (intravenous infusion) to adults with solid tumors that are locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The main goals are to find out how safe CR-001 is, what side effects it might cause, and to determine the highest dose that can be given safely. Researchers will also look at how well CR-001 works. You might be able to join if you are 18 or older, have a life expectancy of at least 3 months, and your cancer can be measured. The study is currently recruiting about 290 participants.

Study design
This is an interventional study with an unspecified phase, planning to enroll 290 participants. It includes dose escalation, backfill, and dose optimization parts, with participants in the dose optimization part being randomized to one of two CR-001 dose levels.
What's involved
You would undergo a screening period, receive treatment for up to 2 years, and have regular clinical and safety assessments, including scans and blood tests. You may also need to provide a tumor tissue sample or undergo a biopsy.
Compensation
Not stated in the trial record.
Follow-up
After treatment ends, you will have disease scans until your disease progresses, and long-term follow-up visits will be conducted by telephone every 3 months.

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NCT07335497

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Crescent Biopharma, Inc.
~290 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:CR-001

At a glance

Recruiting sites
27 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation - Incidence and nature of dose-limiting toxicities
Measured over From the first dose of study drug up until approximately 1 month
+4 more outcomes measured

Conditions

Locally Advanced / Metastatic Solid Tumors

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Where it's being run

28 sites across 22 states
Seoul3
Florida2
Michigan2
Texas2
Madrid2
Alabama1
California1
Colorado1

Study leadership

  • Brad Sumrow, MD · STUDY_DIRECTOR · Crescent Biopharma, Inc.

Who to contact

Crescent Clinical Trials
[email protected]
617-430-5595
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Dose Escalation - Incidence and nature of dose-limiting toxicitiesFrom the first dose of study drug up until approximately 1 month

    Per cohort

  • Dose Escalation - Characterization of the maximum tolerated dose, if applicableFrom the first dose of study drug up until approximately 1 month

    Per Cohort

  • All parts - Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and treatment - emergent serious adverse eventsFrom the first dose of study drug until 90 days after the last dose of study drug

    Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  • All parts - Incidence and severity of TEAEs leading to dose modificationsFrom 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 discontinuationFrom the first dose of study drug until 90 days after the last dose of study drug