A Phase I Trial of HS-10241 in Solid Tumors

NCT02759640 | Completed Phase 1

• 1 other identifier: HS-10241-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects with solid tumors. HS-10241 will be administered orally once daily.

Conditions

Neoplasm; Solid Tumors

Keywords

c-Met kinase inhibitor; Advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  MTD is defined as the maximum dose level at which no more than 1 out of 3 participants experience a DLT within the first 4 weeks of multiple dosing.

  4 weeks

Secondary Outcomes (8)

• Number of participants with treatment-emergent adverse events (TEAEs)

  24 months

• Peak plasma concentration (Cmax)

  4 weeks

• Area under the plasma concentration-time curve (AUC）

  4 weeks

• T1/2 (half-life)

  4 weeks

• Objective response rate (ORR)

  24 months

Study Arms (1)

HS-10241

EXPERIMENTAL

HS-10241 is administered orally starting at 100 mg/day.

Drug: HS-10241

Interventions

HS-10241 DRUG

HS-10241 is administered orally starting at 100 mg/day.

HS-10241

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Ability to understand the purposes and risks of the trial and his/her informed consent using the Human Research Ethics Committee (HREC) approved informed consent form (ICF).
• Histologically or cytologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed, or has been refused.
• Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of at least 3 months
• Acceptable liver function defined below:
• Total bilirubin ≤ 2 times upper limit of normal range (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; however, ≤5 times ULN in a subject who has liver metastases
• Acceptable renal function defined below:
• Serum creatinine ≤1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) ≥60 mL/minutes
• Acceptable coagulation status defined below:
• Prothrombin time \<1.5 times ULN
• Partial thrombin time \<1.5 times ULN
• Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:

You may not qualify if:

• Hematologic malignancies
• Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
• Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris
• Seizure disorders requiring anticonvulsant therapy
• Taking a medication that prolongs QT interval and has a risk of Torsade de Pointes, or a history of long QT syndrome
• Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
• Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry. Ongoing androgen deprivation therapy or bisphosphonates are allowed.
• Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 1 year of trial entry)
• History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis;
• Subject is pregnant (positive serum beta human chorionic gonadotropin \[β-HCG\] test at Screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment
• Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (2)

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Liverpool

Liverpool, New South Wales, 2170, Australia

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 20, 2022

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)