A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects with Advanced Solid Tumors and Lymphoma.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516289-12-00

Acronym

CYC065-101

Enrollment

Registered

2024-08-06

Start date

2022-02-24

Completion date

2025-01-07

Last updated

2024-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

and MBC post-CDK4/6 inhibitor, B-cell lymphoma, Biliary tract cancer, Breast cancer (metastatic HER-2 refractory, Endometrial cancer, Hepatocellular carcinoma, HER-2 negative, Hormone receptor +, Metastatic colorectal cancer, Ovarian cancer, T-cell lymphoma, Triple-negative) Basket cohort: tumor types that are suspected to have a related mechanism of action and are not included in previous groups

Brief summary

Phase 1: The incidence rate of dose-limiting toxicities (first cycle only) at each dose level. Phase 2: ORR according to Response Evaluation Criteria in Solid Tumors: RECIST guidelines (Lugano Criteria for lymphoma, mSWAT for CTCL) for each tumor type

Detailed description

Safety, Disease control rate (DCR), Response rate as per Lugano Criteria for lymphoma, mSWAT for CTCL, Progression-free survival, Duration of response, Overall survival, PK in Phase 1

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1: The incidence rate of dose-limiting toxicities (first cycle only) at each dose level. Phase 2: ORR according to Response Evaluation Criteria in Solid Tumors: RECIST guidelines (Lugano Criteria for lymphoma, mSWAT for CTCL) for each tumor type	—

Secondary

Measure	Time frame
Safety, Disease control rate (DCR), Response rate as per Lugano Criteria for lymphoma, mSWAT for CTCL, Progression-free survival, Duration of response, Overall survival, PK in Phase 1	—

Countries

Spain

Outcome results