Clinical Trials in the USA / NCT06801236
Recruiting
Phase 1
Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06801236 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Prostate Cancer (Adenocarcinoma)mCRPC (Metastatic Castration-resistant Prostate Cancer)
Investigational drug(s) / intervention(s)
ACE-232 tablets
ACE-232 tablets: ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Study summary
This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).
Eligibility
Inclusion Criteria:
* Provide written informed consent
* Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy
* Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment;
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has a life expectancy of at least 6 months
* Adequate organ function and bone marrow function
Exclusion Criteria:
* Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
* Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong the QT interval.
* Any previous treatment-related toxicities have not recovered.
* Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.
* Severe cardiovascular disorders.
* Known gastrointestinal (GI) disorder or GI procedure
* History of gastric and duodenal perforation.
* History of pituitary dysfunction.
* Poorly controlled diabetes mellitus.
* Active or uncontrolled autoimmune disease
* Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
* Other malignancies requiring treatment within 3 years prior to the first dose of study drug
* Known allergy or hypersensitivity to any of the excipients of ACE-232.
* Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.
Primary outcome measure(s)
- Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs) — From time of information consent to 30 days post last dose, up to approximately 37 months
Number of patients with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination, etc. - Number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol — From the first dose of ACE-232 on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (at the end of 28 days)
A DLT is defined as any toxicity events related to ACE-232 that occur from the first dose of study treatment until the planned end date of Cycle 1 (DLT assessment period), meeting the criteria specified in protocol. - Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) — Up to approximately 37 months
RP2D will be finally determined by the SMC and sponsor based on all data from the dose escalation module and backfill module, as well as the exposure-response relationship evaluated (if available). MTD is defined as the maximum dose level at which ≤1 patient have DLTs during the DLT observation period, and it should be determined with 6 evaluable patients.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California San Diego, Moores Cancer Center | La Jolla | California | Recruiting |
| Moffitt Cancer Center, Tampa | Tampa | Florida | Recruiting |
| University of Maryland, Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | Recruiting |
| Harvard Medical School-Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| M Health Fairview Clinics and Surgery Center | Minneapolis | Minnesota | Recruiting |
| Xcancer (Urology Cancer Center) | Omaha | Nebraska | Withdrawn |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | Recruiting |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | Recruiting |
| Beijing Gobroard Hospital | Beijing | China | Not Yet Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | China | Not Yet Recruiting |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China | Not Yet Recruiting |
| Henan Cancer Hospital | Zhengzhou | China | Not Yet Recruiting |
| Fujian Cancer Hospital | Fuzhou | Fujian | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06801236 on ClinicalTrials.gov ↗ ← All trials in the USA