Investigating CYC140 for advanced solid tumors and lymphoma

A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CYC140, an Oral PLK1 Inhibitor, in Subjects With Advanced Solid Tumors and Lymphoma

This study is testing a new oral medication called CYC140 to see if it can help people with advanced solid tumors or lymphoma that haven't responded to other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cyclacel Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 5 sites (Duarte, California and 4 other locations)
• Trial ID: NCT05358379 on ClinicalTrials.gov

What this trial studies

This is a two-part, phase 1/2, open-label, multicenter study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, pharmacogenomics, and efficacy of CYC140, an oral medication. The study includes a dose-escalation and dose-finding component in Phase 1, followed by Phase 2, which enrolls subjects with advanced solid tumors or lymphoma that have progressed despite standard therapies or for which no standard therapies exist. Participants will be grouped based on specific cancer types, including bladder, breast, lung, liver, colorectal cancers, and various lymphomas.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors or lymphoma who have failed standard therapies or cannot tolerate them.

Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that currently have limited or no effective therapies.

How similar studies have performed: Other studies investigating similar targeted therapies have shown promise, but this specific approach with CYC140 is novel.

Eligibility criteria

Inclusion Criteria:

1. Males or females aged ≥ 18 years.
2. Subjects with histological- or cytological-confirmed, advanced cancer who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists

   1. For Phase 1, all tumor types may be enrolled
   2. For Phase 2, subjects will be enrolled as per the study design section above
3. ECOG performance status of 0-2.
4. Subjects who relapsed post-autologous or post-allogeneic transplant are eligible. Post-transplant subjects must be without active fungal disease or significant acute graft-versus-host disease
5. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval.
6. 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.
7. Able to agree to and sign the informed consent and to comply with the protocol.

Exclusion Criteria:

1. Subjects with a history of brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. Subjects with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible.
2. Subjects who have not received vaccines for severe acute respiratory syndrome-corona virus-2 (SARS-COV-2) and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19.
3. Subjects with a history of another primary malignancy, other than:

   1. In situ carcinomas, e.g., breast, cervix, and prostate
   2. Locally excised nonmelanoma skin cancer
   3. No evidence of disease from another primary cancer for 2 or more years and has not taken any anti-cancer treatment in 2 years.
4. Any other clinically significant acute or chronic medical or psychiatric condition or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results.
5. Diseases that significantly affect GI absorption of CYC140.
6. Subjects who have impaired cardiac function or clinically significant cardiac disease.
7. Presence of active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment
8. Presence of an active infection requiring intravenous antibiotics
9. Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism
10. Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV).
11. Chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 3 weeks (whichever is shorter) prior to administration of first dose of study drug on Day 1 or have not recovered from the side effects of such therapy.
12. Major surgery/surgical therapy for any cause within 4 weeks of the first dose

Where this trial is running

Duarte, California and 4 other locations

• City of Hope — Duarte, California, United States (Recruiting)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Mark H Kirschbaum, MD

Conditions Solid Tumor, Adult Lymphoma