Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
ConditionAdvanced Solid Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgiamune Inc
About this trial
GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
ECOG performance status 0-1.
Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
Recommended Double methods of contraception 90-days post treatment Cancer Specific
Disqualifiers
Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
Women who are pregnant or breastfeeding
History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
Trial design
Design model
Single group
Treatments tested in this trial
GIM122
DrugGIM-122 administered IV once every 3 weeks or every 2 weeks
Treatment groups
111 Participants
are divided into 1 treatment groupGroup A: Intravenous administration of GIM-122Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicities [DLT] with GIM-122
To identify dose limiting toxicities \[DLT\] with GIM-122
Time frame
18 months2
Maximum tolerated dose [MTD] of GIM-122
To identify maximum tolerated dose \[MTD\] of GIM-122
Time frame
18 months3
Recommended Phase 2 Dose [RP2D] of GIM-122
To identify Recommended Phase 2 Dose \[RP2D\] of GIM-122
Time frame
18 Months4
Overall response rate (ORR) -Part B of the study
To identify overall response rate (ORR) in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy
Time frame
36 monthsSecondary outcomes
1
Area under the plasma concentration versus time curve (AUC)
To preliminarily evaluate the AUC in patients with advanced malignant tumors
Time frame
36 months2
Peak Plasma Concentration (Cmax)
To preliminarily evaluate Cmax in patients with advanced malignant tumors
Time frame
36 months3
Time of peak plasma concentration (Tmax)
To preliminarily evaluate Tmax in patients with advanced malignant tumors
Time frame
36 months4
Overall Response Rate (ORR) - Part A of the study
To preliminarily evaluate ORR in patients with advanced malignant tumors
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov