- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05673109
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)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Accutar Biotechnology
- Phone Number: 9292620884
- Email: medical@accutarbio.com
Study Locations
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Beijing, China
- Site 2001
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Guangzhou, China
- Site 2003
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Hunan, China
- Site 2004
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Nanchang, China
- Site 2005
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Shanghai, China
- Site 2002
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male patients who are ≥ 18 years old when signing the ICF.
- 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.
- 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.
- 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.
- The performance status score of the Eastern Cooperative Oncology Organization (ECOG) is 0-1.
- Male patients with female partners of childbearing potential are required to use two forms of acceptable contraceptive measures.
- 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:
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.
- 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]).
- 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.
- Patients with known brain metastasis.
- Male patients who plan to have children during the study or within 90 days after the last dose of investigational drug.
- 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
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;
- Patients presenting evidence(s) which is(are), in the opinion of the investigator, indicative of any serious or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses or active infection, with no need to screen for chronic diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AC176
Single agent dose escalation of AC176.
AC176 will be given orally (PO) on a 28-day cycle.
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AC176 will be given orally (PO) on a 28-day cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events (AEs)/Serious adverse events (SAEs)
Time Frame: Through study completion, approximately 24 months
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Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC176
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Through study completion, approximately 24 months
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Clinically significant abnormalities in vital signs
Time Frame: Through study completion, approximately 24 months
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Vital signs abnormalities as characterized by type, frequency, severity and timing;
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Through study completion, approximately 24 months
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Clinically significant abnormalities in laboratory tests
Time Frame: Through study completion, approximately 24 months
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Laboratory abnormalities as characterized by type, frequency, severity and timing;
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Through study completion, approximately 24 months
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Clinically significant abnormalities in electrocardiogram (ECG)
Time Frame: Through study completion, approximately 24 months
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Electrocardiogram (ECG) abnormalities such as QTcF, PR, RR and QRS intervals
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Through study completion, approximately 24 months
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Clinically significant abnormalities in heart rate
Time Frame: Through study completion, approximately 24 months
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Through study completion, approximately 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate-specific antigen (PSA) response rates based on Prostate Cancer Working Group 3 (PCWG3) criteria.
Time Frame: Throughout the study, approximately 24 months
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PSA response rate per PCWG3
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Throughout the study, approximately 24 months
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Objective Response Rate(ORR)
Time Frame: Throughout the study, approximately 24 months
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Throughout the study, approximately 24 months
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Radiographic progression-free survival (rPFS)
Time Frame: Throughout the study, approximately 24 months
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Throughout the study, approximately 24 months
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Time to progression (TTP)
Time Frame: Throughout the study, approximately 24 months
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Throughout the study, approximately 24 months
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Duration of response (DoR)
Time Frame: Throughout the study, approximately 24 months
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Throughout the study, approximately 24 months
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Progression-free survival (PFS)
Time Frame: Throughout the study, approximately 24 months
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Throughout the study, approximately 24 months
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Pharmacokinetic Analysis
Time Frame: 24 weeks
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Area under the concentration-time curve over the dosing interval (AUC(0-tau))
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24 weeks
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Pharmacokinetic Analysis
Time Frame: 24 weeks
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Maximum plasma concentration (Cmax)
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24 weeks
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Pharmacokinetic Analysis
Time Frame: 24 weeks
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Terminal elimination half life (t1/2)
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24 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC176-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on AC176
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Accutar Biotechnology IncTerminatedMetastatic Castration Resistant Prostate CancerUnited States