Recruiting
Phase 1
Phase 2

CYC140

Sponsor:

Cyclacel Pharmaceuticals, Inc.

Code:

NCT05358379

Conditions

Solid Tumor, Adult Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CYC140

Study Details

Brief summary:

This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, pharmacogenomics, and efficacy of CYC140 administered orally daily. 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 for which no standard therapy exists.

Conditions

Solid Tumor, Adult Lymphoma

Study ID

NCT05358379

Start date

Apr 14, 2022

Status verified date

Feb, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

330 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 Dose Escalation

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.

experimental: Phase 2

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

Interventions

CYC140

CYC140 is a highly selective, orally- and intravenously- available, ATP-competitive inhibitor of PLK1.

Primary outcome measure

  • Maximum tolerated dose [ Time Frame: 6 months ]
  • Overall Response Rate (ORR) [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Julius Huang, PhD

jhuang@cyclacel.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Miguel Villalona-Calero, MD

mvillalona@coh.org

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Cyclacel Pharmaceuticals, Inc.

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cyclacel Pharmaceuticals, Inc. on 2024-02-07.