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TERMINATEDPHASE1

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of AC176 in Chinese Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT05673109•Accutar Biotechnology Inc

View on ClinicalTrials.gov

Summary

This clinical trial is evaluating a drug called AC176 in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least one prior systemic therapy. The main goals of this study are to: Evaluate the safety and tolerability of AC176, evaluate pharmacokinetics and preliminary antitumor activity of AC176

Detailed Description

AC176-002 is a Phase I, open-label, multi-center dose-escalation study of AC176 given orally as a single agent. The AC176 is an investigational medicinal product that is a potent orally bioavailable Androgen Receptor (AR) degrader studied for the treatment of patients with metastatic castration resistant prostate cancer.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Male patients who are ≥ 18 years old when signing the ICF.
•2. Patients with histologically, pathologically or cytologically confirmed mCRPC, except for any suspected neuroendocrine or small cell carcinoma. Patients with disease progression confirmed according to the Prostate Cancer Working Group 3 (PCWG3) Criteria, following standard of care, or for whom standard of care is inappropriate (they cannot tolerate or are unwilling to receive the standard of care), or for whom no therapy with proven efficacy is available.
•3. Patients with disease progression meeting at least one of the following PCWG3 criteria:Positive bone scan (≥ 2 new lesions) or soft tissue metastases on CT/MRI ; or If PSA progression is the sole criterion for progression, its starting value of ≥ 1.0 ng/mL has been elevated twice at least 1 week apart.
•4. Patients must have disease progression (in any stage of prostate cancer) after at least 1 of previously approved systemic therapies, at least 1 of which is Abiraterone, Enzalutamide, Apalutamide or Darolutamide.
•5. The performance status score of the Eastern Cooperative Oncology Organization (ECOG) is 0-1.
•6. Male patients with female partners of childbearing potential are required to use two forms of acceptable contraceptive measures.
•7. Life expectancy ≥ 3 months after initiation of treatment, in the investigator's opinion.

Exclusion Criteria

•Patients meeting any of the following criteria will be excluded from the study:
•1. Patients who have received any of the following treatments:
•More than 2 lines of chemotherapy at any stage of prostate cancer treatment; Any systemic anti-cancer chemotherapy, biological agent in the previous treatment regimen or clinical study within 4 weeks prior to the first dose of the investigational drug; any systemic small molecule drug within 2 weeks prior to the first dose or 5 half-lives (whichever is longer, but no more than 4 weeks), except for the use of ADT for medical castration purposes; Any investigational drugs in previous clinical studies within 4 weeks before the first dose of the study treatment; Radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of the investigational drug; or radiotherapy for remission within 2 weeks prior to the first dose. Palliative radiotherapy for relieving the pain caused by bone metastases.
•2. Patients who have any \> Grade 1 unresolved toxicity from prior therapy at the time of initiation of study treatment, except for alopecia and ≤ Grade 2 peripheral neuropathy (as assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\]).
•3. Patients who have received any major surgery(ies) (with the exception of the placement of vascular access) within 4 weeks prior to the first dose of the investigational drug.
•4. Patients with known brain metastasis.
•5. Male patients who plan to have children during the study or within 90 days after the last dose of investigational drug.
•6. Patients who have any condition that impairs their ability to swallow a tablet whole, or have active gastrointestinal disease or other conditions that may significantly interfere with the absorption, distribution, metabolism or excretion of AC176
•7. Patients whose cardiac functions currently meet or met the following criteria in the past 6 months:
•Mean corrected QT interval (QTc) in resting ECG is \> 470 ms; Resting ECG shows clinically significant abnormalities ; Presence of any potential risk factors that may prolong QTc interval or increase the risk of arrhythmia, Left ventricular ejection fraction (LVEF) is \< 50% or \< the study site's LLN;
+1 more criteria

Locations (5)

Site 2001

Beijing, China

Site 2003

Guangzhou, China

Site 2004

Hunan, China

Site 2005

Nanchang, China

Site 2002

Shanghai, China

Key Dates

Start Date

February 22, 2023

Primary Completion Date

October 8, 2023

Completion Date

October 8, 2023

Last Updated

January 25, 2024

Enrollment

ACTUAL participants

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

AC176

DRUG

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

RECRUITINGPHASE1

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

NCT06830850

Metastatic Castration Resistant Prostate Cancer

View study

RECRUITING

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone