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
Qualifiers
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
Treatments tested in this trial
- HS-10502
Treatment groups
318 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov