A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors
ConditionAdvanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntengene Biologics Limited
About this trial
This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
Aged at least 18 years as of the date of consent.
Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or not applicable for standard therapy(ies).
Dose Escalation Phase: all solid tumors.
Disqualifiers
Primary central nervous system disease or central nervous system metastatic disease.
Prior exposure to a Claudin 18.2 targeting agent.
Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (eg, a period of 5 'half-lives'.
Prior vaccination within 28 days of the first dose of study therapy.
Trial design
Design model
Sequential
Treatments tested in this trial
ATG-022
DrugDose Escalation Phase: A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg once every 3 weeks (Q3W) with 1 subject ,the following dose cohorts (0.9, 1.8, 2.4, 3.0, and 3.6 mg/kg Q3W) will require at least 3 and up to 6 evaluable subjects by using dose escalation plan of "3+3" design.
Treatment groups
156 Participants
are divided into 1 treatment groupGroup A: ATG-022Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT
Number of Participants with Dose Limiting Toxicity
Time frame
Up to 21 Days2
MTD
Maximum Tolerated Dose
Time frame
Up to 21 Days3
RP2D
RP2D= Recommended Phase 2 Dose
Time frame
Up to 21 DaysSecondary outcomes
1
PFS
Progression Free Survival
Time frame
12 months after the last subject enrolled2
ORR
Overall Response Rate
Time frame
12 months after the last subject enrolled3
DOR
Duration of Response
Time frame
12 months after the last subject enrolledOther outcomes
1
OS
Overall Survival
Time frame
12 months after the last subject enrolledSponsors and contacts
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Source ClinicalTrials.gov