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

NCT05378178 | Unknown Phase 1

• 1 other identifier: HS-10381-101
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

HS-10381; SHP2; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of HS-10381

  To determine the MTD of HS-10381 in subjects with advanced solid tumors.

  4 weeks after initiation of treatment

Secondary Outcomes (8)

• Incidence and severity of treatment-emergent adverse events

  Baseline through study completion(28 days after last dose)

• Observed maximum plasma concentration (Cmax) after single dose of HS-10381

  From pre-dose to 120 hours after single dose on Cycle 0 Day 1.

• Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-10381

  From pre-dose to 24 hours after the dose on Cycle 2 Day 1

• Apparent terminal half-life (t1/2) after single dose of HS-10381

  From pre-dose to 120 hours after single dose on Cycle 0 Day 1

• Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-10381

  From pre-dose to 24 hours after single dose on Cycle 0 Day 1

Study Arms (1)

Phase I：Dose escalation

EXPERIMENTAL

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

Drug: HS-10381

Interventions

HS-10381 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.

Phase I：Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged more than or equal to (≥) 18 years
• Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
• 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)
• ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
• Estimated life expectancy greater than (\>) 12 weeks
• 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
• Sign Informed Consent Form

You may not qualify if:

• Treatment with any of the following:
• Previous or current treatment with drugs targeting SHP2
• Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
• 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.
• Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
• Known and untreated, or active central nervous system metastases.
• Existing abnormal CTCAE≥grade 2 resulted from previous treatment
• History of other malignancy
• Inadequate bone marrow reserve or organ function
• Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
• History of hypersensitivity to any active or inactive ingredient of HS-10381.
• 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.
• Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Xi’an, Sichuan, 610044, China

RECRUITING

Study Officials

• You Lu

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

You Lu, PhD

CONTACT

18980601763; radyoulu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 18, 2022
• Study Start: June 8, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

CN (1)