To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

NCT05405439 | Terminated Phase 1

• 1 other identifier: TQB3823-Ib/II-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 23

Brief Summary

This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT)

  The relevant adverse reactions occurred within the first cycle

  Up to 4 weeks

• Recommended phase II dose (RP2D)

  The dose of TQB3823 tablet which is recommended to use during phase II clinical trial

  Up to 8 weeks

• The ratio of subject radiographic progression-free survival for 12 months

  Proportion of subjects without disease progression assessed by radiology within 12 months

  For 12 months

• Adiographic progression-free survival (rPFS)

  rPFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause evaluated by radiological examination

  Up to 24 months

Secondary Outcomes (13)

• The ratio of subject radiographic progression-free survival for 12 months

  For 6 months

• The ratio of prostate specific antigen (PSA) reduction

  Up to 24 months

• Overall response rate (ORR) based on 2014 Lugano

  Up to 24 months

• Overall survival (OS)

  Up to death

• Clinical benefit rate (CBR)

  Up to 24 months

Study Arms (1)

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets

EXPERIMENTAL

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.

Drug: TQB3823 tablets; Drug: Abiraterone acetate tablets; Drug: prednisone acetate tablets

Interventions

TQB3823 tablets DRUG

TQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets

Abiraterone acetate tablets DRUG

Abiraterone acetate tablet is an inhibitor of cytochrome P450 17（CYP17）

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets

prednisone acetate tablets DRUG

Prednisone acetate tablet is a kind of glucocorticoids

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged 18 to 85.
• Subjects with pathologically proven with prostate adenocarcinoma.
• Metastatic disease confirmed by imaging (eg, bone scan and CT/MRI).
• The patient's serum testosterone level at the screening visit was ≤ 1.73 nmol/L (50 ng/dL). Patients who did not undergo bilateral orchiectomy required continued ADT \[gonadotropin-releasing hormone analog (LHRHa, agonist/antagonist)\] treatment throughout the study period.
• Disease progression during consecutive androgen deprivation therapy (ADT), defined at study entry, as meeting one or more of the following criteria:
• At least two consecutive PSA elevations separated by at least 1 week, the last result must be at least 1.0 ng/mL.
• Soft tissue lesion progression as assessed by RECIST 1.1 with or without PSA progression.
• Bone disease progression assessed by PCWG3, i.e., ≥2 new lesions detected on bone scan, ≥2 new bone lesions other than those previously assessed on reassessment at least 8 weeks later, with ≥2 previously assessed bone lesions still exist, regardless of PSA progression.
• Patients must discontinue all prior cancer therapy (except ADT and bone loss prophylaxis) and have recovered to ≤ Grade 1 or baseline (according to the Common Terminology Criteria for Adverse Events) prior to first dose of all acute toxic effects of prior therapy or surgery Version 5.0 \[CTCAE v 5.0\]), with the exception of alopecia and peripheral neuropathy, and the washout period since the last prior systemic or radiation therapy was as follows:
• At least 4 weeks must have elapsed since enrollment with 5-alpha reductase inhibitors (eg, dutasteride, finasteride), estrogen, and cyproterone.
• At least 4 weeks must have elapsed from major surgery or radiation therapy to enrollment。
• Laboratory indicators meet the requirements.

You may not qualify if:

• For subjects with brain metastases with symptoms or symptom control for less than 1 month, screening for CNS metastases at baseline is not required unless there are signs and/or symptoms of CNS involvement.
• Subjects who have developed or is currently suffering from other malignancies within 3 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
• Subjects who have accepted botanicals (such as saw palmetto) that may lower PSA levels within 4 weeks before the first dose.
• Subjects who have accepted oral targeted drugs within 5 drug half-lives from the first dose (calculated from the end of the last treatment).
• Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.
• Subjects who have previously accepted CYP17 enzyme inhibitors (including drugs such as abiraterone, TAK-700, TOK-001, and ketoconazole, ect.,) or second generation androgen receptor inhibitors (including enzalutamide, apalutamide, darolutamide , etc.) (mHSPC, nmCRPC stage).
• The study accept patients who received McRpc-based chemotherapy with CYP17 inhibitors other than abiraterone or second-generation androgen receptor inhibitors or paclitaxel for less than 3 months without disease progression, However, 4 weeks or 5 half-life washing out period is required (whichever is longer).
• Patients who received abiraterone in the mCRPC phase for less than 3 months and did not progress (no need to stop elution) are allowed in the study, but cannot be enrolled in the phase I cohort of a single drug population in this study.
• Subjects who receive medications known to be potent inhibitors of cytochrome P450 3A4 (CYP3A4) or potent or moderate inducers and unable to discontinue these medications or switch to another for at least 5 half-lives prior to initiation of study medication different medicines.
• Subjects who suffer from contraindications to prednisone (corticosteroid) use, such as active systemic infection (e.g. bacterial infection requiring intravenous antibiotics at initiation of study treatment, fungal infection, or detectable viral infection requiring systemic therapy ) or viral load (e.g. known HIV positive or known active hepatitis B or C (e.g. hepatitis B surface antigen positive). Screening for contraindications other than HIV/HBV and HCV is not required to determine eligibility.
• Subjects with history of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest CT scan during screening.
• Subjects with any chronic condition requiring corticosteroid treatment at doses greater than "Prednisone 5mg, BID";

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (23)

The First Hospital of Peking University

Beijing, Beijing Municipality, 100034, China

Location

The Southwest Hospitai of Amu

Chongqing, Chongqing Municipality, 400083, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 401147, China

Location

The Second Hospital of Harbin Medical University

Lanzhou, Gansu, 730030, China

Location

Sun Yat-Sun University Cancer Prevertion and Treatment Center

Guangzhou, Guangdong, 510060, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210003, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110004, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200336, China

Location

The First Affiliated Hospital of The Chinese People's Liberation Army Air Force Military Medical University

Xi’an, Shanxi, 710032, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, 610000, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621099, China

Location

Zigong Fourth People's Hospital

Zigong, Sichuan, 643000, China

Location

Cancer Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China

Location

The First Affiliated Hospital of Wenzhou Medical Univerity

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Interventions

Abiraterone Acetate; Prednisone

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Study Design

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

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 6, 2022
• Study Start: August 25, 2022
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

CN (23)