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

NCT03569280 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: KPG-121-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Castration-Resistant Prostate Cancer

Keywords

KPG-121; Enzalutamide; Abiraterone; Apalutamide; Non-metastatic and Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121

  MTD is one dose level below the dose level that results in ≥33% of subjects with a DLT

  Cycle-1 (28-day)

Secondary Outcomes (2)

• Incidence of Adverse Events [Safety and Tolerability]

  Up to Cycle-6 (28-day per cycle)

• Pharmacokinetic (PK) profile of KPG-121

  Cycle-1 (up to 28-day)

Study Arms (1)

KPG-121

EXPERIMENTAL

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

Combination Product: Enzalutamide or Abiraterone or Apalutamid

Interventions

Enzalutamide or Abiraterone or Apalutamid COMBINATION_PRODUCT

Antitumor treatment

KPG-121

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent provided prior to any study-related procedure being performed;
• Able to swallow and retain orally administered medication;
• Male aged 18 years and older;
• diagnosis of prostate carcinoma;
• Men with either non-metastatic or metastatic CRPC are eligible;
• 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;
• Serum testosterone level \<50 ng/dL (\<0.5 ng/mL, \<7.0 nmol/L).
• ECOG performance status of 0 or 1;
• Adequate baseline organ function;
• 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;
• 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;
• Willing and able to comply with all protocol required visits and assessments.

You may not qualify if:

• Prior chemotherapy, radiation;
• Prior malignancy other than CRPC.
• Uncontrolled hypothyroidism, or TSH \>2.0 x ULN at screening.
• Current use of or anticipated requirement of prohibited medication(s);
• Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy;
• Previous history of difficulty swallowing capsules;
• Known active infection requiring intravenous (IV);
• Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test ;
• 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;
• Poorly controlled hypertension;
• Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
• History or evidence of cardiovascular risk; known cardiac metastases;
• Previous major surgery within 30 days prior to the start of study medication;

Sponsors & Collaborators

• Kangpu Biopharmaceuticals, Ltd.: lead

Study Sites (3)

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide; abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yao Wang

  Kangpu Biopharmaceuticals, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: KPG-121 Plus Enzalutamide or Abiraterone or Apalutamid

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 26, 2018
• Study Start: November 26, 2019
• Primary Completion: January 10, 2023
• Study Completion: June 15, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)