A PhaseⅠStudy of HS-10381 in Patients With Advanced Solid Tumors

NCT ID: NCT05378178

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2024-12-31

Brief Summary

HS-10381 is a small molecular, oral potent, SHP2 inhibitor. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10381 in Patients With Advanced Solid Tumors.

Detailed Description

This is a Phase 1 open-label, multicenter study to evaluate the safety, tolerability, PK and preliminary efficacy of HS-10381 in patients with advanced solid tumors by using a "3+3" dose escalation.

Conditions

Advanced Solid Tumor

Study Design

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

Study Groups

Phase I：Dose escalation

HS-10381 given orally QD of various dose strengths administered in 21 day dosing cycles.

Group Type: EXPERIMENTAL

HS-10381

Intervention Type: DRUG

Each subject will receive a single dose(C0) of HS-10381 and then repeat doses(C1, C2…) for 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Interventions

HS-10381

Each subject will receive a single dose(C0) of HS-10381 and then repeat doses(C1, C2…) for 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men or women aged more than or equal to (≥) 18 years

2. Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable

3. Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)

4. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks

5. Estimated life expectancy greater than (>) 12 weeks

6. Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential

7. Sign Informed Consent Form

Exclusion Criteria

1. Treatment with any of the following:

1. Previous or current treatment with drugs targeting SHP2

2. Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug

3. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.

4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.

5. Known and untreated, or active central nervous system metastases.

2. Existing abnormal CTCAE≥grade 2 resulted from previous treatment

3. History of other malignancy

4. Inadequate bone marrow reserve or organ function

5. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV

6. History of hypersensitivity to any active or inactive ingredient of HS-10381.

7. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

8. 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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

You Lu

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital of Sichuan University

Xi’an, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

You Lu, PhD

Role: CONTACT

radyoulu@hotmail.com

18980601763

Facility Contacts

You Lu, PhD

Role: primary

radyoulu@hotmail.com

18980601763

Other Identifiers

HS-10381-101

Identifier Type: -

Identifier Source: org_study_id