CYC140 for Advanced Cancers and Lymphoma

Recruiting at 4 trial locations

Overseen By Julius Huang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Cyclacel Pharmaceuticals, Inc.

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Brain metastases, Cardiac disease, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

330 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new oral drug, CYC140, in patients with advanced cancers who have no other treatment options. It aims to see if the drug is safe and effective in stopping cancer growth or killing cancer cells.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain treatments like chemotherapy, biologic therapy, targeted therapy, immunotherapy, or investigational agents at least 3 weeks or 5 half-lives before starting the study drug. If you're on these treatments, you may need to stop them before joining the trial.

Eligibility Criteria

Adults (≥18 years) with advanced solid tumors or lymphoma that have worsened after standard therapy, or when no standard treatment is available. They must be able to take oral medication and not have GI issues affecting drug absorption. Participants need a stable health status, confirmed by an ECOG score of 0-2, and agree to use effective birth control.

Inclusion Criteria

I can take care of myself and perform daily activities.

I can swallow pills and don't have major stomach or bowel issues affecting drug absorption.

I am not pregnant or will use birth control during and 6 months after the study.

Exclusion Criteria

I am currently on IV antibiotics for an infection.

I haven't been vaccinated for COVID-19 and show symptoms or have it confirmed.

I haven't had cancer treatments or still have side effects within the last 3 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

CYC140 administered orally in escalating doses starting at 5mg QD M-F week 1 to 3 for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved.

4 weeks per cycle

Phase 2 Treatment

Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• CYC140

Trial Overview The trial is testing CYC140, taken orally daily in two phases: Phase 1 for safety and dosage in various cancers; Phase 2 focuses on effectiveness in specific cancers. It's open-label so everyone knows they're getting the drug, and it measures how the body processes it.

Participant Groups

Group I: Phase 2 Experimental Treatment 1 Intervention

Phase 2 = Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles.

Group II: Phase 1 Dose Escalation Experimental Treatment 1 Intervention

Phase 1 = CYC140 administered orally in escalating doses starting at 5mg QD M-F week 1 to 3 for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved.

Who Is Running the Clinical Trial?

Cyclacel Pharmaceuticals, Inc.

Lead Sponsor

Trials

20

Recruited

2,100+