Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients

Recruiting at 5 trial locations

Overseen By YONG GUO, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Kangpu Biopharmaceuticals, Ltd.

Must be taking: Enzalutamide, Abiraterone, Apalutamide

Must not be taking: Prohibited medications

Disqualifiers: Chemotherapy, Radiation, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Up to 6 cycles (28-day per cycle)

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called KPG-121, taken regularly, in adult subjects. The study aims to determine the safest dose and how well it works.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that current use of or anticipated requirement of prohibited medications is an exclusion criterion. It is best to discuss your specific medications with the trial coordinators.

Research Team

Yao Wang

Principal Investigator

Kangpu Biopharmaceuticals, Ltd.

Eligibility Criteria

Inclusion Criteria

Able to swallow and retain orally administered medication;

Histologically or cytologically confirmed diagnosis of prostate carcinoma;

Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;

Exclusion Criteria

You have a severe medical condition affecting your brain or nervous system.

You have received chemotherapy, radiation or experimental immunotherapy within the last 4 weeks. Limited radiation to control bone pain is allowed.

You cannot take certain medications during the study, including experimental drugs, anti-cancer treatments, and certain herbs or supplements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

3+3 dose escalation design to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121

28 days

Cycle-1 (up to 28-day)

Treatment

Participants receive KPG-121 capsules at different dose levels for 21 days in 28-day treatment cycles

Up to 6 cycles (28-day per cycle)

Cycle-1 to Cycle-6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abiraterone
• Apalutamide
• Enzalutamide
• KPG-121

Participant Groups

Group I: KPG-121 Experimental Treatment 1 Intervention

Safety and Antitumor Activity of KPG-121 capsules at different dose level for 21 days

Who Is Running the Clinical Trial?

Kangpu Biopharmaceuticals, Ltd.

Lead Sponsor

Trials

4

Recruited

150+