Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC).

This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival（rPFS） based on BICR assessment

Study Overview

• Status: Not yet recruiting
• Conditions: High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
• Intervention / Treatment: Drug: dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets; Drug: placebo; abiraterone acetate tablets; prednisone tablets

• Study Type: Interventional
• Enrollment (Estimated): 660
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Feng Liu; Phone Number: +86-18875033874; Email: feng.liu.fl10@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age of ≥ 18 years old,male
2. ECOG PS score of 0 or 1；
3. Prostate adenocarcinoma confirmed by histological。
4. ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression
5. Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration)
6. Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent

Exclusion Criteria:

1. Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer
2. Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy
3. Confirmed by imaging, there are brain tumor foci
4. History of severe lung disease such as interstitial pneumonia
5. Plan to receive any other antitumor therapy during this trial
6. Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dalpiciclib+ abiraterone+ prednisone	Drug: dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets; dalpiciclib+ abiraterone+ prednisone
Placebo Comparator: placebo+abirarerone+prenisone	Drug: placebo; abiraterone acetate tablets; prednisone tablets; placebo+abirarerone+prenisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse event (AE) incidence	approximately 63 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK： Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)		approximately 6 months
rPFS	Time from randomisation to radiologically confirmed progressive disease or death due to any cause	approximately 63 months
PSA response rate	In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week	approximately 63 months
ORR	Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses	approximately 63 months
Time to PSA progression	Time from randomisation to the first time of PSA progression	approximately 63 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypersensitivity; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisone; Abiraterone Acetate
• Other Study ID Numbers: SHR6390-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No