NCT05168904

A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety and Efficacy of Fadraciclib (CYC065), an Oral CDK 2/9 Inhibitor, in Subjects With Leukemias or Myelodysplastic Syndrome (MDS)

Suspended Phase 1/Phase 2 Last updated 6 February 2024

What this trial tests

Phase 1/Phase 2 trial testing fadraciclib in Leukemia in 210 participants. Suspended.

Timeline

22 October 2021

Primary endpoint
1 October 2024

1 December 2024

Quick facts

Lead sponsor	Cyclacel Pharmaceuticals, Inc.
Phase	Phase 1/Phase 2
Status	Suspended
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	210
Start date	22 October 2021
Primary completion	1 October 2024
Estimated completion	1 December 2024
Sites	2 locations across United States

Drugs / interventions tested

• fadraciclib — full drug profile →

Conditions studied

• Leukemia — all drugs for Leukemia →
• Myelodysplastic Syndrome(MDS) — all drugs for Myelodysplastic Syndrome(MDS) →

Sponsor

Cyclacel Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Leukemia or Myelodysplastic Syndrome(MDS). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Maximum tolerated dose
  Time frame: 6 months
  The incidence rate of dose-limiting toxicities (first cycle only) at each dose level
• Overall Response Rate (ORR)
  Time frame: 18 months
  Assessment of response criteria according to iwCLL criteria for CLL/SLL and IWG criteria for AML and MDS.

Sponsor's own description

This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety and efficacy of fadraciclib (formerly CYC065) administered orally BID. This study consists of Phase 1 and Phase 2 components in subjects with Leukemia or Myelodysplastic syndrome (MDS) who have progressed despite having standard therapy or for which no standard therapy exists.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Small molecule inhibitors targeting the cancers.
   Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
2. The Renaissance of Cyclin Dependent Kinase Inhibitors.
   Ettl T, Schulz D, Bauer RJ. · · 2022 · cited 50× · PMID 35053461 · DOI 10.3390/cancers14020293
3. Targeting CDK9 with selective inhibitors or degraders in tumor therapy: an overview of recent developments.
   Xiao L, Liu Y, Chen H, Shen L. · · 2023 · cited 41× · PMID 37272701 · DOI 10.1080/15384047.2023.2219470
4. Small molecules targeting protein-protein interactions for cancer therapy.
   Wu D, Li Y, Zheng L, Xiao H, et al · · 2023 · cited 39× · PMID 37799384 · DOI 10.1016/j.apsb.2023.05.035
5. Targeting the Heterogeneous Genomic Landscape in Triple-Negative Breast Cancer through Inhibitors of the Transcriptional Machinery.
   van der Noord VE, van de Water B, Le Dévédec SE. · · 2022 · cited 11× · PMID 36139513 · DOI 10.3390/cancers14184353
6. Cyclin Dependent Kinase 2 (CDK2) Inhibitors in Oncology Clinical Trials: A Review.
   House I, Valore-Caplan M, Maris E, Falchook GS. · · 2025 · cited 5× · PMID 39811424 · DOI 10.36401/jipo-24-22
7. Advancing Leukemia Management Through Liquid Biopsy: Insights into Biomarkers and Clinical Utility.
   Hollanda CN, Gualberto ACM, Motoyama AB, Pittella-Silva F. · · 2025 · cited 4× · PMID 40361366 · DOI 10.3390/cancers17091438
8. METTL3-driven m⁶A epigenetics in gastric cancer: unveiling oncogenic networks and clinical translation from tumorigenesis to therapy resistance.
   Fu X, Ruan X, He J. · · 2025 · cited 1× · PMID 41003789 · DOI 10.1007/s10565-025-10086-8