NCT06873555

A Study of DC05F01 in Chinese Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors

Phase Ib/IIa Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of DC05F01 in Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Heronova Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, cohort expansion Phase Ib/IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of DC05F01 in patients with recurrent/refractory ovarian cancer and other advanced solid tumors.

Detailed description

The study consists of two parts. Part A will expand the Phase I study based on safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy data to select the recommended Phase II dose (RP2D, tentatively set at 2100 mg). The study plans to enroll 10 patients with recurrent/refractory ovarian cancer into Cohort 1, 10 patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy into Cohort 2, and 20 patients with other advanced malignant solid tumors into Cohort 3. All patients will receive oral DC05F01 once daily, continuously, with a 4-week treatment cycle to assess the efficacy, safety, and pharmacokinetic profile of DC05F01. Part B will be determined based on the efficacy and safety data from Part A, with the investigator and sponsor jointly deciding on the appropriate indications for further expansion. It plans to enroll 20 patients to further evaluate the efficacy and safety of DC05F01.

Conditions

• Solid Tumors
• Ovarian Cancer
• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	DC05F01	DC05F01 capsule

Timeline

• Start date: 2024-09-11
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-03-12
• Last updated: 2025-03-19

Locations

2 sites across 1 country: China