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Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients
Phase 1
Waitlist Available
Research Sponsored by Kangpu Biopharmaceuticals, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to cycle-6 (28-day per cycle)
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to cycle-6 (28-day per cycle)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to cycle-6 (28-day per cycle)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121
Secondary study objectives
Incidence of Adverse Events [Safety and Tolerability]
Pharmacokinetic (PK) profile of KPG-121
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: KPG-121Experimental Treatment1 Intervention
Safety and Antitumor Activity of KPG-121 capsules at different dose level for 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide or Abiraterone or Apalutamid
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Kangpu Biopharmaceuticals, Ltd.Lead Sponsor
3 Previous Clinical Trials
134 Total Patients Enrolled
Yao Wang, MDStudy DirectorKangpu Biopharmacuticals
YONG GUO, MDStudy DirectorKangpu Biopharmacuticals
Yao WangStudy DirectorKangpu Biopharmaceuticals, Ltd.