A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APG-2449 Monotherapy or in Combination With Anticancer Agents in Patients With Platinum-resistant Recurrent Ovarian Cancer or Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.

• Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.

• At least one measurable tumor lesion.

• ECOG score is 0\

• Life expectancy of ≥3 months.

• AE caused by previous treatment must recover to ≤ grade 1.

• Sufficient bone marrow, liver, kidney and coagulation function.

• Female patients must be in a non-pregnant and non-lactating state.

• Able to understand and willing to sign informed consent.

• Patients are required to provide fresh or archived tumor tissue samples prior to treatment.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yifan Zhai, M.D., Ph.D.
yzhai@ascentage.com
+86-20-28068501
Backup
Wentao Pan, Ph.D.
Wentao.Pan@ascentage.com
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2027-05
Participants
Target number of participants: 50
Treatments
Experimental: APG -2449 Monotherapy
Part A: Monotherapy for advanced solid tumors.
Experimental: APG -2449 combined with PLD
Part B: Dose exploration and expansion of APG-2449 combined PLD.
Related Therapeutic Areas
Sponsors
Leads: Ascentage Pharma Group Inc.

This content was sourced from clinicaltrials.gov