A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors

NCT ID: NCT05911464

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2027-10-31

Brief 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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HS-10386

Participants will receive HS-10386 once daily. The duration of each treatment cycle is 21 days.

Group Type: EXPERIMENTAL

HS-10386

Intervention Type: DRUG

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

Interventions

HS-10386

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shun Lu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingxing Liu

Role: CONTACT

liuxx2@hspharm.com

+86 18652105536

Facility Contacts

Shun Lu, Dr.

Role: primary

Shun_lu@hotmail.com

Other Identifiers

HS-10386-101

Identifier Type: -

Identifier Source: org_study_id