A Phase I Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)

Study Identifier:
ACE-232-001
CT.gov Identifier:
NCT06801236
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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).

Evaluate the safety and tolerability of ACE-232 in patients with metastatic castration-resistant prostate cancer (mCRPC); 2. Determine the phase II recommended dose (RP2D) and maximum tolerated dose (MTD) of ACE-232.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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 Informed consent has been obtained, and I am willing to follow the research instructions and comply with the research requirements.
  • Metastatic castration-resistant prostate cancer requires maintenance androgen deprivation therapy (ADT) or has undergone bilateral orchiectomy.
  • Refractory or intolerant to standard treatment (having received at least one line of NHA and taxane chemotherapy in CSPC or CRPC stage)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy > 6 months
  • Organ function and bone marrow function are normal
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. During the washout period specified in the protocol, any anti-tumor or other treatments, major surgery, wide-field or local radiotherapy are not permitted.
  • It is necessary to use in combination with drugs that are known to be moderate to strong CYP3A4 inhibitors/inducers or P-gp inhibitors, or drugs known to prolong the QT interval.
  • No recovery from any previous treatment-related toxicities
  • Spinal cord compression (within 4 weeks) or known brain metastases or leptomeningeal carcinoma
  • Severe cardiovascular disease
  • Known gastrointestinal (GI) disease or GI surgery
  • History of gastric and duodenal perforation
  • History of pituitary dysfunction
  • Poorly controlled diabetes
  • Active or poorly controlled autoimmune diseases
  • Active infection, or a known history of human immunodeficiency virus (HIV) infection, or a known history of active hepatitis B or C, or a known history of active tuberculosis.
  • Patients with other malignant tumors requiring treatment within 3 years prior to the first administration of the study drug.
  • Known allergy or hypersensitivity to any excipients used in ACE-232
  • The presence of other medical conditions, in the researcher's judgment, could interfere with the evaluation of the study's safety or efficacy, or affect treatment adherence.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruiting
Condition(s) Treated at Site
Prostate