A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma
- Registration Number
- NCT04983810
- Lead Sponsor
- Cyclacel Pharmaceuticals, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 330
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase I Dose escalation Fadraciclib Phase I = Fadraciclib administered orally in escalating doses starting at 50mg bid MWF 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. Phase 2 = Recommended Fadraciclib phase 2 dose and schedule administered orally in 28 day cycles.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) 18 months Assessment of response criteria according to RESIST, Lugano or mSWAT
Maximum tolerated dose 6 months The incidence rate of dose-limiting toxicities (first cycle only) at each dose level
- Secondary Outcome Measures
Name Time Method Tmax 6 months Fadraciclib plasma concentrations
AUC 6 months Fadraciclib plasma concentrations
Adverse events 24 months Type, frequency, and severity of adverse drug reactions
Cmax 6 months Fadraciclib plasma concentrations
T1/2 6 months Fadraciclib plasma concentrations
Trial Locations
- Locations (4)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
City of Hope
🇺🇸Duarte, California, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain