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NCT04983810
A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma
Phase 1, PHASE2 trial testing Fadraciclib in Solid Tumor, Adult in 330 participants. Status unknown.
30 April 2025
Quick facts
| Lead sponsor | Cyclacel Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 330 |
| Start date | 12 July 2021 |
| Primary completion | 30 April 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 4 locations across United States, Spain, South Korea |
Drugs / interventions tested
- Fadraciclib — full drug profile →
Conditions studied
- Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
- Lymphoma — all drugs for Lymphoma →
Sponsor
Cyclacel Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Solid Tumor, Adult or Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cyclin-dependent protein kinases and cell cycle regulation in biology and disease.
Pellarin I, Dall'Acqua A, Favero A, Segatto I, et al · · 2025 · cited 132× · PMID 39800748 · DOI 10.1038/s41392-024-02080-z -
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 -
The Renaissance of Cyclin Dependent Kinase Inhibitors.
Ettl T, Schulz D, Bauer RJ. · · 2022 · cited 50× · PMID 35053461 · DOI 10.3390/cancers14020293 -
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 -
The Emerging Role of Super-enhancers as Therapeutic Targets in The Digestive System Tumors.
Li XP, Qu J, Teng XQ, Zhuang HH, et al · · 2023 · cited 32× · PMID 36923930 · DOI 10.7150/ijbs.78535 -
Super-enhancers and novel therapeutic targets in colorectal cancer.
Liu Q, Guo L, Lou Z, Xiang X, et al · · 2022 · cited 22× · PMID 35277481 · DOI 10.1038/s41419-022-04673-4 -
Seize the engine: Emerging cell cycle targets in breast cancer.
Fuentes-Antrás J, Bedard PL, Cescon DW. · · 2024 · cited 21× · PMID 38264947 · DOI 10.1002/ctm2.1544 -
Cyclin-dependent kinase inhibitor fadraciclib (CYC065) depletes anti-apoptotic protein and synergizes with venetoclax in primary chronic lymphocytic leukemia cells.
Chen R, Chen Y, Xiong P, Zheleva D, et al · · 2022 · cited 21× · PMID 35383271 · DOI 10.1038/s41375-022-01553-w
Verify or expand the search:
- PubMed search for NCT04983810
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fadraciclib
Trials testing the same drug.
- NCT05817890 — Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects · EARLY_PHASE1 · completed
Other recruiting trials for Solid Tumor, Adult
Currently open trials in the same condition.
- NCT07139990 — Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM) · Phase 1 · recruiting
- NCT06398418 — R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients · Phase 1 · recruiting
- NCT06682793 — A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumor · Phase 1, PHASE2 · recruiting
- NCT07137195 — Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei) · NA · active not recruiting
- NCT06714617 — Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
Other Cyclacel Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT05817890 — Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects · EARLY_PHASE1 · completed
- NCT04017546 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS · Phase 1 · completed
- NCT03884829 — A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS · Phase 1 · terminated
- NCT03739554 — CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL · Phase 1 · completed
- NCT02552953 — A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04983810 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cyclacel Pharmaceuticals, Inc.
- Last refreshed: 25 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04983810.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing