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A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors
This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors.
Study details:
This is a Phase I, multi-center, open-label, dose-finding study of ATG-022 in patients with advanced solid tumours. The study design includes a Dose Escalation Phase which will enroll subjects with advanced/metastatic solid tumors, and a Dose Expansion Phase which will enroll select advanced/metastatic solid tumors with Claudin 18. 2-positive expression at the defined maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) to further evaluate the safety, tolerability, and efficacy of ATG-022.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-03-27
Primary completion: 2026-06-30
Study completion finish: 2026-06-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05718895
Intervention or treatment
DRUG: ATG-022
Conditions
- • Advanced/Metastatic Solid Tumors
Find a site
Closest Location:
Cancer Research SA Pty Ltd
Research sites nearby
Select from list below to view details:
Cancer Research SA Pty Ltd
Adelaide, Not Specified, Australia
Cabrini Health Limited
Malvern, Not Specified, Australia
Integrated Clinical Oncology Network Pty Ltd (Icon)
South Brisbane, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: ATG-022
| DRUG: ATG-022
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
DLT | Number of Participants with Dose Limiting Toxicity | Up to 21 Days |
MTD | Maximum Tolerated Dose | Up to 21 Days |
RP2D | RP2D= Recommended Phase 2 Dose | Up to 21 Days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
PFS | Progression Free Survival | 12 months after the last subject enrolled |
ORR | Overall Response Rate | 12 months after the last subject enrolled |
DOR | Duration of Response | 12 months after the last subject enrolled |
Frequently Asked Questions
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