A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK 2/9 Inhibitor, in Subjects With Advanced Solid Tumors and Lymphoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 330
- Locations
- 4
- Primary Endpoint
- Overall Response Rate (ORR)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase I Dose escalation
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.
Intervention: Fadraciclib (Drug)
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: 18 months
Assessment of response criteria according to RESIST, Lugano or mSWAT
Maximum tolerated dose
Time Frame: 6 months
The incidence rate of dose-limiting toxicities (first cycle only) at each dose level
Secondary Outcomes
- Tmax(6 months)
- AUC(6 months)
- Adverse events(24 months)
- Cmax(6 months)
- T1/2(6 months)