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CYC140 for Advanced Cancers and Lymphoma

Phase 1 & 2
Recruiting
Research Sponsored by Cyclacel Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-2
Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, CYC140, to see if it is safe and effective in treating advanced solid tumors and lymphoma.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of CYC140 are not listed here, common ones from similar cancer drugs include nausea, fatigue, risk of infection due to lowered immunity, diarrhea or constipation, and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I can swallow pills and don't have major stomach or bowel issues affecting drug absorption.
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My advanced cancer has worsened despite standard treatments, or I can't tolerate them.
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I had a stem cell transplant and don't have active fungal infections or severe graft-versus-host disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose
Overall Response Rate (ORR)
Secondary outcome measures
AUC
Adverse events
Cmax
+6 more
Other outcome measures
Pharmacodynamics
Pharmacogenomics

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
Phase 2 = Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles.
Group II: Phase 1 Dose EscalationExperimental Treatment1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for lymphoma include chemotherapy, targeted therapies, and immunotherapies. Chemotherapy drugs, such as cyclophosphamide and doxorubicin, work by damaging the DNA of rapidly dividing cells, leading to cell death. Targeted therapies, like Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib) and BCL2 inhibitors (e.g., venetoclax), specifically target molecular pathways crucial for lymphoma cell survival and proliferation. Immunotherapies, including monoclonal antibodies (e.g., rituximab), enhance the immune system's ability to recognize and destroy cancer cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific characteristics of the lymphoma, potentially improving outcomes and minimizing side effects.

Find a Location

Who is running the clinical trial?

Cyclacel Pharmaceuticals, Inc.Lead Sponsor
19 Previous Clinical Trials
1,846 Total Patients Enrolled
3 Trials studying Lymphoma
364 Patients Enrolled for Lymphoma

Media Library

Lymphoma Clinical Trial 2023: CYC140 Highlights & Side Effects. Trial Name: NCT05358379 — Phase 1 & 2
~110 spots leftby Aug 2025
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