Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

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

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

TQB3823 tablets

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

Abiraterone acetate tablets

Prednisone acetate tablet is a kind of glucocorticoids

prednisone acetate tablets

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.

This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.

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

Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

The relevant adverse reactions occurred within the first cycle

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

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

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

Proportion of subjects without disease progression assessed by radiology within 6 months

Proportion of subjects with reduction of PSA

Percentage of participants achieving complete response (CR) and partial response (PR).

OS defined as the time from randomization until the death from any cause

Proportion of subjects with clinical benefit

The time when the participants first achieved CR or PR to disease progression or death from any cause.

Time to progression of bone disease in subjects

The time it takes for the drug's concentration in the body to drop by half

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Amino Acids

Antibodies

Androgens

Antibodies, Bispecific

Immunoglobulins

Mitogens

Afatinib

Androgen Receptor Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with afatinib 40 mg orally once daily.

Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with the AR targeting agent they experienced disease progression on prior to study entry:

enzalutamide 160 mg orally once daily or abiraterone 1000 mg orally once daily with prednisone 5 mg orally twice daily.

Participants will receive intravenous infusion of 750 mg of zenocutuzumab once every 2 weeks in combination with the AR targeting agent they experienced disease progression on prior to study entry:

enzalutamide 160 mg orally once daily or abiraterone 1000 mg orally once daily with prednisone 5 mg orally twice daily

anti epidermal growth factor receptor (EGFR)/HER2 agent

Afatinib Oral Tablet

second-generation androgen receptor antagonist

Enzalutamide Pill

full length IgG1 bispecific antibody targeting HER2 and HER3

MCLA-128

Shekeab Jauhari, MD

Study Coordinator

Paul La Porte, MD

Alexander Philipovskiy, MD, PhD

Mark Goldstein, MD

Leslie Cheteyan

Wassim Abida, MD, PhD

Benjamin Kuritzky, MD

Pedro Barata, MD

Stephan D Kendall, MD

Li Zhang, MD

This is a Phase II, open-label, 2-arm, multicenter, international study designed to evaluate the efficacy of zenocutuzumab alone or in combination in patients with the following diagnoses:

Group A: NRG1+ NSCLC Group B: mCRPC

Study Design:

This is an open label (all participants know the identity of the study drug), multicenter (more than one study site), study consisting of 2 parts:

Group A (NRG1+ NSCLC): Approximately 50 NRG1+NSCLC patients will be enrolled and will receive zenocutuzumab in combination with afatinib 40 mg orally once daily.

Group B (mCRPC): Up to 40 mCRPC patients will be enrolled and will receive zenocutuzumab in combination with the AR targeting agent enzalutamide or abiraterone on which they experienced disease progression immediately before study entry.

For the administration of zenocutuzumab in combination in Groups A and B, the Treatment Period will include 2 phases, an initial safety run-in phase, and an expansion phase with an interim efficacy analysis.

The study will consist of 4 periods: Screening, Treatment, Safety Follow-up, and Long-term Follow up.

Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers

A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers

Objective Response Rate (ORR) by local assessment per RECIST v1.1

Objective Response Rate (ORR) per RECIST v1.1

Duration of Response (DOR) per RECIST v1.1

Progression-free Survival (PFS) per RECIST v1.1

Frequency and nature of adverse events (AEs) that are related to treatment as assessed by Common Terminology Criteria for AEs (CTCAE) version 5.0

Incidence of antidrug antibodies against zenocutuzumab

Serum titers of antidrug antibodies against zenocutuzumab

Radiographic Progression Free Survival (rPFS) by local investigator per Prostate Cancer Clinical Trials Working Group 3 Modified Response Evaluation Criteria in Solid Tumors (PCWG3-modified RECIST) v1.1 and Overall Survival (OS)

Duration of Response (DOR) per PCWG3-modified RECIST v1.1

Time to Response (TTR) per PCWG3-modified RECIST v1.1

time to Prostate-specific antigen (PSA) progression per PCWG3-modified RECIST v1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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	Metastatic Cast...	TQB3823 tablets Abiraterone ace... prednisone acet...	18 Years - 85 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers	NCT05588609	NSCLC Harboring... Metastatic Cast...	Afatinib Oral T... Enzalutamide Pi... Abiraterone ace... MCLA-128	18 Years -	Merus N.V.

Spots Global Cancer Trial Database for abiraterone acetate tablets