A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma

  • STATUS
    Recruiting
  • End date
    Nov 9, 2025
  • participants needed
    330
  • sponsor
    Cyclacel Pharmaceuticals, Inc.
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Updated on 9 May 2022
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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.

Description

Phase 1 part of the study will consist of a dose-escalation and a dose-finding component.

Phase 2 will enroll subjects with locally advanced, recurrent, or metastatic, histologically confirmed advanced solid tumors or lymphoma, who have failed all standard therapies or for whom standard therapy does not exist, into 8 groups:

Group 1: Bladder cancer

Group 2: Breast cancer: Triple-negative breast cancer (TNBC)

Group 3: Lung cancer (non-small cell lung cancer [NSCLC] and small cell lung cancer [SCLC])

Group 4: Hepatocellular carcinoma (HCC) and biliary tract cancer (BTC)

Group 5: Metastatic colorectal cancer (mCRC) including KRAS-mutated mCRC

Group 6: B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL)

Group 7: T-cell lymphoma (cutaneous T-cell lymphoma [CTCL] and peripheral T-cell lymphoma [PTCL])

Group 8: Basket cohort: tumor types that are suspected to have a related mechanism of action but are not included in previous groups including, esophageal, prostate, ovarian and pancreatic cancers

Details
Condition Solid Tumor, Adult Lymphoma
Treatment CYC140
Clinical Study IdentifierNCT05358379
SponsorCyclacel Pharmaceuticals, Inc.
Last Modified on9 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Males or females aged ≥ 18 years
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
For Phase 1, all tumor types may be enrolled
For Phase 2, subjects will be enrolled as per the study design section above
ECOG performance status of 0-2
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
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
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
Able to agree to and sign the informed consent and to comply with the protocol

Exclusion Criteria

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
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
Subjects with a history of another primary malignancy, other than
In situ carcinomas, e.g., breast, cervix, and prostate
Locally excised nonmelanoma skin cancer
No evidence of disease from another primary cancer for 2 or more years and has not taken any anti-cancer treatment in 2 years
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
Diseases that significantly affect GI absorption of CYC140
Subjects who have impaired cardiac function or clinically significant cardiac disease
Presence of active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment
Presence of an active infection requiring intravenous antibiotics
Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism
Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV)
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
Major surgery/surgical therapy for any cause within 4 weeks of the first dose
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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