CR-001 for Cancer

(ASCEND Trial)

Not yet recruiting at 4 trial locations

Overseen By Crescent Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Crescent Biopharma, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Brad Sumrow, MD

Principal Investigator

Crescent Biopharma, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced or widespread solid tumors, such as pancreatic cancer. Participants should be able to receive the experimental treatment CR-001 and have not found success with other treatments.

Inclusion Criteria

Life expectancy ≥ 3 months

Have measurable disease defined by RECIST v1.1

I am willing to provide a recent tumor sample or undergo a biopsy.

Exclusion Criteria

I have not had any other cancers in the last 3 years.

I need to take higher doses of steroids for my condition.

I am still recovering from a recent major surgery.

What Are the Treatments Tested in This Trial?

Interventions

• CR-001

Trial Overview

The study is testing the safety of a new therapy called CR-001 on its own. It aims to find the highest dose patients can take without serious side effects and determine an effective dose for future studies.

How Is the Trial Designed?

Group I: CR-001 Dose escalation Experimental Treatment 1 Intervention

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

Group II: CR-001 Dose Optimization Cohort Y Experimental Treatment 1 Intervention

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

Group III: CR-001 Dose Optimization Cohort X Experimental Treatment 1 Intervention

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

Group IV: CR-001 Backfill Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Crescent Biopharma, Inc.

Lead Sponsor