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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Abiraterone Acetate; Prednisone

Criteria

Inclusion Criteria:

• 1 Male patients aged 18 to 85.

• 2 Subjects with pathologically proven with prostate adenocarcinoma.

• 3 Metastatic disease confirmed by imaging (eg, bone scan and CT/MRI).

• 4 Metastatic prostate cancer progresses in the presence of castration therapy.

• 5 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。

• 6 Disease progression during consecutive ADT/post orchiectomy, defined at study entry, as meeting one or more of the following criteria:

1. At least two consecutive PSA elevations separated by at least 1 week, the last result must be at least 1.0 ng/mL if PSA elevation is determined to be the only evidence of progression. Patients receiving antiandrogen therapy must have PSA progression after discontinuation (≥ 4 weeks since last flutamide dose, or ≥ 6 weeks since last bicalutamide or nilutamide).

2. Disease progression assessed by RECIST 1.1 with or without PSA progression.

3. Bone disease progression assessed by PCWG3, i.e., ≥2 new lesions detected on bone scan and ≥2 new bone lesions other than those previously assessed on reassessment at least 8 weeks later, regardless of PSA progression.

• 7 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:

1. At least 4 weeks must have elapsed since enrollment with 5-alpha reductase inhibitors (eg, dutasteride, finasteride), estrogen, and cyproterone.

2. At least 4 weeks must have elapsed from major surgery or radiation therapy to enrollment。

• 8 Laboratory indicators meet the requirements.

Exclusion Criteria:

• 1 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.

• 2 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.

• 3 Subjects who have accepted botanicals (such as saw palmetto) that may lower PSA levels within 4 weeks before the first dose.

• 4 Subjects who have accepted oral targeted drugs within 5 drug half-lives from the first dose (calculated from the end of the last treatment).

• 5 Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.

• 6 Subjects who have previously accepted CYP17 enzyme inhibitors, including drugs such as abiraterone, TAK-700, TOK-001, and ketoconazole.

• 7 Subjects who have previously received paclitaxel-based chemotherapy or newer antiandrogens (eg, enzalutamide, abiraterone) (patients are allowed to use paclitaxel-based chemotherapy in the mHSPC stage).

• 8 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.

• 9 Subjects who suffer from contraindications to prednisone (corticosteroid) use, such as active systemic infection (eg, bacterial infection requiring intravenous antibiotics at initiation of study treatment, fungal infection, or detectable viral infection requiring systemic therapy ) or viral load (eg known HIV positive or known active hepatitis B or C [eg hepatitis B surface antigen positive]. Screening for this is not required to determine eligibility.

• 10 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.

• 11 Subjects with any chronic condition requiring corticosteroid treatment at doses greater than "Prednisone 5mg, BID";