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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ACE-232
  • Drug: 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.

Recruiting Locations

Harvard Medical School-Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

More Details

Status
Recruiting
Sponsor
Acerand Therapeutics (Hong Kong) Limited

Study Contact

Sherwin Cai, MD
86-18983021726
sherwin.cai@acerand.com

Detailed Description

The study consists of two parts, Phase 1A dose escalation and Phase 1B dose optimization. Phase 1A aims to assess the safety, tolerability, pharmacokinetic (PK) profile, and changes in pharmacodynamic (PD) markers in patients treated with ACE-232, and to determine the maximum tolerated dose (MTD), if applicable. In Phase 1B, patients with AR gene alterations will be treated at two different dose levels to establish the recommended Phase 2 dose (RP2D).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.