NCT07335497 · Crescent Biopharma, Inc.
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
(ASCEND)
What this study is about
The purpose of this study is to determine the safety and how well patients handle the treatment of treatment given alone 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
- Denver, Colorado
- Orlando, Florida
- Sarasota, Florida
- Detroit, Michigan
- Grand Rapids, Michigan
- New York, New York
- Columbus, Ohio
- Nashville, Tennessee
- Dallas, Texas
- San Antonio, Texas
- West Valley City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations