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

NCT ID: NCT03569280

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-26
• Study Completion Date: 2023-06-15

Brief Summary

This is a Phase 1, open-label, multicenter study of KPG-121 administered orally once daily (QD) in 28-day treatment cycles to adult subjects.

Detailed Description

This Phase 1 study will comprise two parts: Part 1 will be a 3+3 dose escalation design to characterize the MTD and a RP2D, Part 2 will be an expansion cohort at RP2D.

Conditions

Castration-Resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KPG-121

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

Group Type: EXPERIMENTAL

Enzalutamide or Abiraterone or Apalutamid

Intervention Type: COMBINATION_PRODUCT

Antitumor treatment

Interventions

Enzalutamide or Abiraterone or Apalutamid

Antitumor treatment

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent provided prior to any study-related procedure being performed;

2. Able to swallow and retain orally administered medication;

3. Male aged 18 years and older;

4. diagnosis of prostate carcinoma;

5. Men with either non-metastatic or metastatic CRPC are eligible;

6. Completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for Part 1), or with fixed stable dose enzalutamide (for Part 2), with no change in dose for at least 2 weeks prior to screening;

7. Serum testosterone level <50 ng/dL (<0.5 ng/mL, <7.0 nmol/L).

8. ECOG performance status of 0 or 1;

9. Adequate baseline organ function;

10. Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) <470 milliseconds (msec) or <480 msec with bundle branch block;

11. 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;

12. Willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria

1. Prior chemotherapy, radiation;

2. Prior malignancy other than CRPC.

3. Uncontrolled hypothyroidism, or TSH >2.0 x ULN at screening.

4. Current use of or anticipated requirement of prohibited medication(s);

5. Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy;

6. Previous history of difficulty swallowing capsules;

7. Known active infection requiring intravenous (IV);

8. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test ;

9. History of seizure or any condition that may predispose subject to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months prior to the start of study medication;

10. Poorly controlled hypertension;

11. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs

12. History or evidence of cardiovascular risk; known cardiac metastases;

13. Previous major surgery within 30 days prior to the start of study medication;

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kangpu Biopharmaceuticals, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yao Wang

Role: STUDY_DIRECTOR

Kangpu Biopharmaceuticals, Ltd.

Locations

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists

Port Jefferson Station, New York, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

KPG-121-101

Identifier Type: -

Identifier Source: org_study_id