Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorAcerand Therapeutics (Hong Kong) Limited
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
ACE-232 tablets
DrugACE-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.
Treatment groups
88 Participants
are divided into 1 treatment groupGroup A: ACE-232Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs)
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.
Time frame
From time of information consent to 30 days post last dose, up to approximately 37 months2
Number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol
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.
Time frame
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)3
Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD)
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.
Time frame
Up to approximately 37 monthsSecondary outcomes
1
Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC)
To determine the pharmacokinetics (PK) using AUC of ACE-232 after a single dose and at steady state after multiple doses.
Time frame
Up to approximately 37 months2
Pharmacokinetics characterization by using Maximum concentration (Cmax)
To determine the pharmacokinetics (PK) using Cmax of ACE-232 after a single dose and at steady state after multiple doses
Time frame
Up to approximately 37 months3
Prostate Specific Antigen (PSA) response
PSA response is defined as PSA decline of 30% and 50% from baseline at any time point
Time frame
Up to approximately 37 months4
Objective Response Rate (ORR)
ORR is defined as a complete response (CR) or partial response (PR), as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) and Prostate Cancer Working Group Criteria 3 (PCWG3 criteria), in patients with measurable disease at baseline.
Time frame
Up to approximately 37 monthsOther outcomes
1
Gene aberrations
To determine the gene aberrations in circulating tumor DNA (ctDNA), and its association with tumor response or resistance to ACE-232
Time frame
Up to approximately 37 monthsSponsors and contacts
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Source ClinicalTrials.gov