Health TrialsbyHealthPanel

Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors

ConditionsSolid Tumor, AdultBRCA1 MutationBRCA2 MutationOvarian CancerBreast CancerProstate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcerand Therapeutics (Shanghai) Limited

About this trial

The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide written informed consent;

Advanced solid tumors, difficult to treat or intolerant to standard treatment, suitable for investigational treatment;

Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

Has a life expectancy of at least 3 months;

Disqualifiers

Receiving any anti-cancer drugs, 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 strong or moderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4);

Receiving continuous corticosteroid treatment with a dose of prednisone greater than 10 mg/day or an equivalent dose.

Receiving continuous treatment with prednisone at a dose of >10 mg/d or other corticosteroids at an equivalent dose for any reason.

Trial design

Design model

Single group

Treatments tested in this trial

  • ACE-86225106 tablet

    Drug

    ACE-86225106 will be administered orally daily as a continuous regimen. 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

298 Participants
are divided into 1 treatment group
Group A: ACE-86225106 tabletExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)

Number of participants 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 3 years
2

The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol

A DLT is defined as any toxicity events related to ACE-86225106 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-86225106 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 Safety Monitoring Committee (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 3 years

Secondary outcomes

1

Objective Response Rate (ORR)

ORR is defined as proportion of patients who achieved complete response (CR) or partial response (PR) according to RECIST 1.1 recorded from first investigational product treatment until disease progression or death due to any cause. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks. For castration-resistant prostate cancer (CRPC) patients, bone lesion will be assessed according to PCWG3 criteria.

Time frame
Up to 3 years
2

Duration of Response (DoR) and Time to Response (TTR)

DOR is defined, for patients with an objective response, as the time from first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause.

Time frame
Up to 3 years
3

Progression Free Survival (PFS)

PFS is defined as the time from the first study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause.

Time frame
Up to 3 years
4

Overall Survival (OS)

OS is defined as the time from the first study treatment to the date of death due to any cause

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acerand Therapeutics (Shanghai) Limited

Lead sponsor

Source ClinicalTrials.gov
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