Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332170
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-18
Brief Title:
ARTEMIS-101 A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
Sponsor:
Hansoh BioMedical RD Company
Organization:
Hansoh BioMedical RD Company
Study Overview
Official Title:
ARTEMIS-101 A Phase 1 Open-label Multi-center Study to Evaluate Safety Tolerability Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HS-20093 is a fully humanized IgG1 antibody-drug conjugate ADC which specifically binds to B7-H3 a target wildly expressed on solid tumor cells The objectives of this study are to investigate the safety tolerability pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients
Detailed Description:
This is a phase 1 open-label multi-center dose-escalation and expansion phase 1 study in Chinses subjects with advanced solid tumors This study is in design allowing assessment of safety tolerability pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents
A total of 5 combination-treatments will be carried out in 3 cohorts The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies and the dose expansion part will enroll patients who have not received prior treatment for advancedmetastatic disease
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists
A total of 5 combination-treatments will be carried out in 3 cohorts The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies and the dose expansion part will enroll patients who have not received prior treatment for advancedmetastatic disease
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None