Phase 1 Study of ACE-232 to Treat Patients with Metastatic Castration-Resistant Prostate Cancer

Acerand Therapeutics (Hong Kong) Limited

Status and phase

Begins enrollment in 1 month

Phase 1

Conditions

Prostate Cancer (Adenocarcinoma)

MCRPC (metastatic Castration-resistant Prostate Cancer)

Treatments

Drug: ACE-232 tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT06801236

ACE-232-001

Details and patient eligibility

About

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).

Full 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).

Enrollment

67 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.