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Trial Title:
A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors
NCT ID:
NCT05740956
Condition:
Ovarian Cancer
Breast Cancer
Pancreatic Cancer
Prostatic Cancer
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Conditions: Keywords:
Poly(ADP-ribose) polymerase-1 inhibitor
HS-10502
Ovarian Cancer
Breast Cancer
Prostate Cancer, Colorectal Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-10502
Description:
HS-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.
Arm group label:
HS-10502
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males or females aged 18 - 75 years (inclusive).
2. Having at least one target lesion per the RECIST v1.1.
3. 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).
4. For the phase Ib study:
Cohort B: patients with HRD positive recurrent ovarian cancer with failure or
intolerance or not available to SoC Cohort C: patients with HRR gene mutation
advanced Human epidermal growth factor receptor 2 (HER2)-negative breast cancer with
failure or intolerance or not available to SoC Cohort D: patients with HRR gene
mutation advanced pancreatic cancer with failure or intolerance or not available to
SoC Cohort E: patients with HRR gene mutation mCRPC with failure or intolerance or
not available to SoC Cohort F: patients with HRR gene mutation colorectal cancer
with failure or intolerance or not available to SoC Cohort G: patients with other
HRR gene mutation or HRD positive advanced solid tumors with failure or intolerance
or not available to SoC
5. Eastern cooperative oncology group (ECOG) performance status was 0-1.
6. Minimum life expectancy > 12 weeks.
7. Females should be using adequate contraceptive measures and should not be
breastfeeding Males should be using adequate contraceptive measures.
8. Have signed Informed Consent Form.
Exclusion Criteria:
1. Received or are receiving the following treatments:
1. Previous or current treatment with two or more Poly(ADP-ribose) polymerase
(PARP) inhibitors.
2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the
first dose of study treatment.
3. 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.
4. 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.
5. Presence of pleural effusion/ascites requiring clinical intervention; presence
of pericardial effusion.
6. Major surgery within 4 weeks prior to the first dose of study treatment.
2. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
3. History of other primary malignancies.
4. Known and untreated, or active central nervous system metastases.
5. Inadequate bone marrow reserve or hepatic and renal functions.
6. Myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or with features
suggestive of MDS or AML.
7. Severe, uncontrolled or active cardiovascular disorders.
8. Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to
the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%.
9. Serious or poorly controlled hypertension.
10. Any life-threatening hemorrhagic event or events requiring blood transfusion within
120 days prior to the first dose of study treatment. Clinically significant
hemorrhagic symptoms or obvious hemorrhagic tendency.
11. Serious infection within 4 weeks prior to the first dose of study treatment, or
presence of uncontrollable active infection in the screening period.
12. Having serious neurological or mental disorders.
13. A history of hypersensitivity to any of the active or inactive ingredients of
HS-10502 or drugs with a similar chemical structure to HS-10502 or in the same class
as HS-10502.
14. Patients who may have poor compliance with the procedures and requirements of the
study, as judged by the investigator.
15. Patients with any condition that jeopardizes the safety of the patient or interferes
with the assessment of the study, as judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Acedemy of Medical Sciences
Address:
City:
Beijing
Zip:
100020
Country:
China
Status:
Recruiting
Contact:
Last name:
Da Wei Wu
Start date:
June 9, 2023
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740956