Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors (NCT06380660) | Clinical Trial Compass
RecruitingPhase 1/2
Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors
China298 participantsStarted 2024-03-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Has measurable disease per RECIST 1.1, castration-resistant prostate Ccancer (CRPC) patients can be assessed according to PCWG3;
✓. Adequate organ function and bone marrow function;
✓. Can provide tumor specimens and blood samples for Homologous Recombination Deficiency (HRD)/ Homologous Recombination Repair (HRR) related gene testing.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs)
Timeframe: 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
Timeframe: 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)
. Any previous treatment-related toxicities have not recovered, i.e., to ≤ Grade 1 (as evaluated by NCI-CTCAE v5), except alopecia and other Grade 2 toxicities that are deemed not to affect the conduct of the study, as assessed by the sponsor and the clinical investigator.
✕. Spinal cord compression or brain metastases unless asymptomatic, treated and stable.
✕. Severe cardiovascular disorders.
✕. Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with evidence suggesting possible MDS/AML.