CT3001 for Advanced Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Crossignal Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged ≥ 18 years (or adult age as per local regulations)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Receiving concurrent anticancer treatment

Females who are pregnant or nursing, or any participant who is planning to become pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug called CT3001 in patients with advanced solid tumors in two phases. The first phase will determine the highest safe dose of the drug, while the second phase will evaluate

Who is the study for?

This trial is for patients with advanced solid tumors, including adenocarcinoma, pancreatic cancer, and colorectal cancer. Participants must have no available therapy options or be unsuitable candidates for such therapies.

What is being tested?

The study tests CT3001 in two phases: Phase 1 to find the right dose by gradually increasing it and checking for harmful effects; Phase 2a to see how well CT3001 works specifically in colorectal or pancreatic cancer at the chosen dose.

What are the potential side effects?

Since this is a first-in-human (FIH) study of CT3001, specific side effects are not yet known but may include typical reactions seen with other cancer treatments like fatigue, nausea, and potential drug-specific risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing treatment for cancer.

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I am not pregnant, nursing, or planning to become pregnant.

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My heart's electrical activity is normal, without prolonged QT or risk of irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.