A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer (NCT05241613) | Clinical Trial Compass
TerminatedPhase 1
A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer
Stopped: Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study
United States28 participantsStarted 2022-03-16
Plain-language summary
This clinical trial is evaluating a drug called AC176 in participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least two prior systemic therapies.
The main goals of this study are to:
* Identify the recommended dose of AC176 that can be given safely to participants
* Evaluate the side effects of AC176
* Evaluate pharmacokinetics of AC176
* Evaluate the effectiveness of AC176
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Males who are at least 18 years-of-age at the time of signature of the informed consent form (ICF)
✓. Patients with histological, pathological, or cytological confirmed diagnosis of advanced or mCRPC who have had disease progression per Prostate Cancer Working Group 3(PCWG3) guidance following standard treatment, including approved taxane-based chemotherapy, or who are not amenable (intolerability, patient choice) to standard therapies, or for whom no therapy of proven efficacy exists.
✓. Advanced or metastatic disease per PCWG3 guidance documented by either:
✓. Patients must have progressed on at least 2 prior approved systemic therapies (in any setting), with at least 1 being abiraterone, or enzalutamide, or apalutamide or darolutamide
✓. Patients who have had surgical or medical castration.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1
✓. Life expectancy ≥3 months after the start of the treatment according to the Investigator's judgment
Exclusion criteria
What they're measuring
1
Incidence of dose limiting toxicities (DLTs) from AC176 monotherapy
✕. With the exception of alopecia and ≤ Grade 2 peripheral neuropathy, any unresolved toxicities from prior therapy greater than the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1 at the time of starting study treatment. Note: subjects with chronic Grade 2 toxicities that are asymptomatic or adequately managed with stable medication may be eligible with Sponsor approval
✕. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
✕. Men who plan to father a child while in the study or within 90 days after the last administration of study treatment
✕. Any condition that impairs a patient's ability to swallow whole pills. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of AC176 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, malabsorption syndrome)
✕. Any of the following cardiac criteria experienced currently or within the last 6 months:
✕. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection. Screening for chronic conditions is not required. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.