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Trial Title:
A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors
NCT ID:
NCT05911464
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced Solid Tumors
Immuno-Oncology Therapy
Immunotherapy
Immune Checkpoint Inhibitor
PD-1
PD-L1
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-10386
Description:
Starting dose 10 mg, administered once daily. If tolerated, subsequent cohorts will test
increasing doses of HS-10386, until a maximum tolerated dose (MTD) or maximum applicable
dose (MAD) is defined
Arm group label:
HS-10386
Summary:
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics,
and preliminary anti-tumor activity of HS-10386 in participants with advanced solid
tumors who have failed prior treatments.
Detailed description:
This is a phase I open label, multicenter clinical study to evaluate the safety,
tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in
subjects with advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, 18-75 years old.
2. Histologically or cytologically documented, incurable or metastatic solid tumors for
which standard treatment either does not exist or has proven ineffective or
unavailable or intolerable.
3. At least one measurable lesion per RECIST v1.1.
4. Willingness to provide fresh or archival tumor biopsy sample.
5. An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no
deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
6. Willingness to use adequate contraceptive measures throughout the study.
7. Ability to comprehend and willingness to sign a written ICF for the study.
Exclusion Criteria:
1. Treatment with any of the following:
1. Previous or current treatment with systemic immunotherapy.
2. Treatment with anticancer medications or investigational drugs within
protocol-defined intervals prior to the first scheduled dose of HS-10386.
2. Any unresolved toxicities from prior therapy greater than Common Terminology
Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
3. Known additional malignancy.
4. History or risk of autoimmune disease.
5. Known primary CNS malignancy or symptomatic CNS metastases. Patients with
asymptomatic CNS metastases may be enrolled after consultation.
6. Inadequate bone marrow reserve or organ function.
7. Clinically significant cardiac disease.
8. Any evidence of severe or uncontrolled systemic diseases
9. Severe infections within 4 weeks prior to the first scheduled dose or symptoms of
infection within 2 weeks prior to prior to the first scheduled dose.
10. History of organ transplantation or any medical condition requiring the use of
systemic immunosuppressive medications.
11. Active HBV or HCV infection that requires treatment.
12. Known history of HIV.
13. Women who are breastfeeding or have a positive urine or serum pregnancy test at the
Screening Visit.
14. Administration of a live, attenuated vaccine within 4 weeks prior to the first
scheduled dose or anticipation that such a live attenuated vaccine will be required
during the study.
15. History of severe anaphylaxis or allergic to any of the components of HS-10386.
16. Any disease or condition that, in the opinion of the investigator, would compromise
the safety of the patient or interfere with study assessments.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu, Dr.
Email:
Shun_lu@hotmail.com
Start date:
March 2, 2023
Completion date:
October 31, 2027
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/NCT05911464
