CYC140 for Advanced Cancers and Lymphoma

Recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called CYC140 (also known as Plogosertib) to determine its safety and effectiveness for individuals with advanced cancers and lymphoma, especially those whose cancer has worsened after standard treatments or for whom no standard treatment is available. The trial consists of two phases: one tests different doses, and the other uses the best dose identified. Individuals with advanced cancer or lymphoma who have not responded to other treatments may be suitable candidates for this trial. Participants should be able to take oral medication and not have serious digestive issues that could affect drug absorption. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that CYC140 is likely to be safe for humans?

Research has shown that CYC140 was safe in earlier studies. CYC140, a pill under investigation, aims to treat advanced cancers and lymphoma. Previous research found it effective against various tumor types. This trial remains in the early stages, so researchers are still gathering detailed safety information. However, reaching this phase indicates that CYC140 has been safe enough to continue testing. Participants in the study will contribute to understanding the safety and effectiveness of this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CYC140 because it offers a novel approach to treating advanced cancers and lymphomas. Unlike traditional chemotherapy, which targets rapidly dividing cells indiscriminately, CYC140 works by inhibiting a specific enzyme involved in cell division, potentially leading to more targeted and effective treatment with fewer side effects. Additionally, CYC140 is administered orally, providing a more convenient option compared to intravenous therapies. This combination of targeted action and ease of administration makes CYC140 a promising candidate in the fight against difficult-to-treat cancers.

What evidence suggests that CYC140 might be an effective treatment for advanced cancers and lymphoma?

Research has shown that CYC140 targets a protein called PLK1, which aids cell division. This makes it a potential treatment for fast-growing cancers, such as advanced solid tumors and lymphoma. Early lab studies found that CYC140 effectively halted cancer cell growth, suggesting it could be promising for patients whose cancer hasn't responded to other treatments. In this trial, participants will receive CYC140 in either a Phase 1 dose escalation arm or a Phase 2 arm to determine the optimal dose and schedule. Ongoing research is examining the effectiveness and safety of CYC140 for people. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05358379?term=PLK1&viewType=Table&rank=2

A Study to Investigate CYC140, in Subjects With Advanced ... This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05358379

NCT05358379 | A Study to Investigate CYC140, in ... This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or ...

3. targetedonc.com targetedonc.com/view/exploration-of-plk1-inhibition-in-advanced-cancers-begins

Exploration of PLK1 Inhibition in Advanced Cancers Begins Based on the preclinical data, researchers suggested that CYC140 could be added to various combination regimens showing promise in advanced ...

4. delta.larvol.com delta.larvol.com/Products/?ProductId=ff4b21c5-272a-4fe1-bb76-0aa848e127ec

plogosertib (CYC140) / Cyclacel Plogosertib and dinaciclib were the most effective inhibitors in all cell lines, representing interesting novel targeted treatment options for ACC.

5. clinicaltrials.eu clinicaltrials.eu/inn/cyc140-monohydrochloride-monohydrate/

Cyc140 Monohydrochloride Monohydrate Ongoing Trials with Cyc140 Monohydrochloride Monohydrate. Study on the Safety and Effectiveness of CYC140 for Patients with Advanced Solid Tumors and Lymphoma.

6. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-cyc140-for-patients-with-advanced-solid-tumors-and-lymphoma/

Study of CYC140 oral medication for patients with ... This study investigates the safety and effectiveness of CYC140, a PLK1 inhibitor, in treating patients with advanced solid tumors and ...

7. medchemexpress.com medchemexpress.com/plogosertib.html?srsltid=AfmBOooluNKgw4z2pfYOKIfC0emsP2uruJNKSmgvWJ3vSQj6e0T8fgrQ

Plogosertib (CYC140) | PLK1 Inhibitor Plogosertib is an anti-cancer agent with anti-proliferative activity. Plogosertib can be used in the research of several tumors, including esophageal, gastric, ...