A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
HS-10502 is a Poly(ADP-ribose) polymerase 1 (PARP1)-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 in subjects with homologous recombination repair (HRR) gene mutant or homologous recombination deficiency (HRD) positive advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females aged 18 - 75 years (inclusive).
Having at least one target lesion per the RECIST v1.1.
For the phase Ia Cohort A: advanced solid tumor carrying HRR gene mutation with failure or intolerance or not available to the currently available Standard of care (SoC).
Eastern cooperative oncology group (ECOG) performance status was 0-1.
Disqualifiers
Previous or current treatment with two or more Poly(ADP-ribose) polymerase (PARP) inhibitors.
Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment.
Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment; Nitrosourea or Mitomycin C within 6 weeks prior to the first dose of study treatment.
Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment.
Trial design
Design model
Single group
Treatments tested in this trial
HS-10502
DrugHS-10502 will be administered once per day on a continuous dosing schedule starting on Cycle 1 Day 1 (C1D1) in a 28-day treatment cycle.
Treatment groups
318 Participants
are divided into 1 treatment groupGroup A: HS-10502Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD) of HS-10502（Stage 1）
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a Dose-limiting toxicity (DLT)
Time frame
Cycle 1 (28 days)2
Maximum applicable dose (MAD) of HS-10502（Stage 1）
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the pharmacokinetics-pharmacodynamics (PK-PD) model, it suggested that the optimal target concentration of safety and efficacy has been explored
Time frame
Cycle 1 (28 days)3
Efficacy of HS-10502: Objective response rate (ORR)（Stage 2）
ORR is defined as the proportion of participants with Best Overall Response (BOR) of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only)
Time frame
From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 yearsSecondary outcomes
1
[Stage 1 and Stage 2] Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as evaluated according to NCI CTCAE v5.0.
Time frame
From Cycle 1 Day 1 (C1D1) until 28 days after the final dose. A cycle is 28 days2
[Stage 1 and Stage 2] PK parameters: The maximum observed concentration (Cmax) of HS-10502
Maximum plasma drug concentration of HS-10502
Time frame
Cycle 1 Day 1 (each cycle is 28 days)3
[Stage 1 and Stage 2] PK parameters: time to Cmax (Tmax) of HS-10502
Time of maximum observed concentration of HS-10502
Time frame
Cycle 1 Day 1 (each cycle is 28 days)4
[Stage 1 and Stage 2] PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502
Area under the curve from the time of dosing to the time of the last measurable (positive) concentration
Time frame
Cycle 1 Day 1 (each cycle is 28 days)Sponsors and contacts
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Source ClinicalTrials.gov