A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    330
  • sponsor
    Cyclacel Pharmaceuticals, Inc.
Updated on 26 April 2022
cancer
lymphoma
advanced cancer

Summary

This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of fadraciclib administered orally BID. 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: Endometrial or Ovarian cancer

Group 2: Biliary tract cancer

Group 3: HCC

Group 4: Breast cancer, meeting any of the following criteria:

  • HER-2 refractory MBC
  • HR positive, HER-2 negative, MBC post-CDK4/6 inhibitor
  • Triple-negative breast cancer (TNBC)

Group 5: B-cell lymphoma

Group 6: T-cell lymphoma (CTCL and PTCL)

Group 7: mCRC, including KRAS mutated mCRC

Group 8: Basket cohort: Tumor types suspected to have a related mechanism of action such as MCL1, MYC or CCNE amplification/overexpression not included in previous groups.

Details
Condition Solid Tumor, Adult, Lymphoma
Treatment Fadraciclib
Clinical Study IdentifierNCT04983810
SponsorCyclacel Pharmaceuticals, Inc.
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 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 or 1
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 t he 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 SARS-COV-2 within last 3 months and have suspected signs and symptoms of COVID-19 or a recent history (within 14 days) of contact with any COVID-19 positive subject/isolation/quarantine or subjects with confirmed COVID-19
Subjects with a history of another primary malignancy, other than
Carcinomas in situ, 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
Diseases that significantly affect GI absorption of fadraciclib
any laboratory abnormality that may increase the risk associated with study
Subjects who have impaired cardiac function or clinically significant cardiac disease
drug administration or may interfere with the interpretation of study results
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
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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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