Advanced Solid Malignancies
Conditions
Keywords
solid tumor, advanced malignancies, GIM-122
Brief summary
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.
Detailed description
This is a Phase 1/2, open label, first-in-human (FIH), multicenter, dose escalation study with enrichments and dose expansion cohorts at RP2D, designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of GIM-122 administered as a single agent in adults with advanced solid malignancies. This study will be conducted in 2 parts: Phase 1 or Part A (dose escalation and enrichment) and Phase 2 or Part B (dose optimization and cohort expansion).
Interventions
DRUGGIM122
GIM-122 administered IV once every 3 weeks or every 2 weeks
Sponsors
Georgiamune Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Part A: Dose Escalation and Enrichment, Part B: Dose Expansion in specified tumor types
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General * 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 * Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor * Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 * Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation * No other lines of therapy that are available
Exclusion criteria
General * 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 * Current second malignancy at other sites * Leptomeningeal disease * Spinal cord compression * Symptomatic or new or enlarging central nervous system (CNS) metastases Treatment-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicities [DLT] with GIM-122 | 18 months | To identify dose limiting toxicities \[DLT\] with GIM-122 |
| Maximum tolerated dose [MTD] of GIM-122 | 18 months | To identify maximum tolerated dose \[MTD\] of GIM-122 |
| Recommended Phase 2 Dose [RP2D] of GIM-122 | 18 Months | To identify Recommended Phase 2 Dose \[RP2D\] of GIM-122 |
| Overall response rate (ORR) -Part B of the study | 36 months | To identify overall response rate (ORR) in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy |
| Anti-tumor activity of GIM-122 | 36 months | To assess anti-tumor activity of GIM-122 as a single agent in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy |
| Incidence and severity of AE / SAEs and tolerability | 36 months | To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | 36 months | To preliminarily evaluate the AUC in patients with advanced malignant tumors |
| Peak Plasma Concentration (Cmax) | 36 months | To preliminarily evaluate Cmax in patients with advanced malignant tumors |
| Time of peak plasma concentration (Tmax) | 36 months | To preliminarily evaluate Tmax in patients with advanced malignant tumors |
| Overall Response Rate (ORR) - Part A of the study | 36 months | To preliminarily evaluate ORR in patients with advanced malignant tumors |
| Duration of response (DOR) | 36 months | To preliminarily evaluate DOR in patients with advanced malignant tumors |
| Disease control rate (DCR) | 36 months | To preliminarily evaluate DCR in patients with advanced malignant tumors |
| Best overall response (BOR) | 36 months | To preliminarily evaluate BOR in patients with advanced malignant tumors |
| Progression-free survival (PFS) | 36 months | To preliminarily evaluate PFS in patients with advanced malignant tumors |
| Overall survival (OS) rates at 12 months | 36 months | To preliminarily evaluate OS in patients with advanced malignant tumors at 12 Months |
| Tumor expression of immunological markers | 36 months | To analyze tumor expression of immunological markers |
Countries
United States
Contacts
CONTACTLumaBridge CRO
PRINCIPAL_INVESTIGATOROmid Hamid, MD
The Angeles Clinic and Research Institute
Outcome results
None listed