Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: GIM-122 active ingredient: Dosage: 20 mg/mL,
Route of Administration: Intravenous (IV) infusion,
Duration of Therapy: Up to 12 Months,
Frequency: Once every 2 weeks (Q2W).
Control Inte
Sponsors
Georgiamune, Inc.
CBCC Global Research
Eligibility
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: In order to be eligible for this study, a subject must meet all of the following criteria: 1. Written informed consent must be obtained prior to any procedures. 2. Subject must be greater than or equal to 18 years of age 3. ECOG performance status 0-1 4. Must have the following laboratory values obtained less than or equal to 28 days prior to enrollment a. Calculated creatinine clearance must be greater than or equal to 30 mL per min by Cockcroft-Gault equation b. Total bilirubin less than or equal to 1.5 the upper limit of normal (ULN) or in the case of known history of Gilberts syndrome, total bilirubin must be less than or equal to 3 the ULN or direct bilirubin less than or equal to 1.5 for the ULN c. Aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 ULN, or less than or equal to 5 ULN for subjects with liver metastases d. Hemoglobin greater than or equal to 9.0 g per dL. Note: Blood product transfusions can be allowed if Hb 8 g per dL - 9.0 g per dL during Screening. e. Platelets greater than or equal to 100 109 cells per L f. Absolute neutrophil count greater than or equal to 1.5 109 cells per L, without the use of hematopoietic growth factors g. Electrocardiogram (ECG) with QT corrected by Fredericia formula (QTcF) less than or equal to 470 ms in females and less than or equal to 450 ms in males (an average QTcF of the triplicate ECGs will be used to confirm eligibility) 5. Male subjects must agree to use a condom plus partner use of a contraceptive method with a failure rate of less than 1 percent per year, and refrain from donating sperm during the treatment period and for at least 90 days after the last dose of study drug. Male subjects with a pregnant partner must use a condom or remain abstinent from vaginal intercourse during the study and for 3 months following the birth. If the female partner plans to breastfeed, the male subject must discuss contraception with their physician prior to unprotected sex. 6. Female subjects of childbearing potential, defined as any female who has not been amenorrheic for 12 months without an alternative medical cause or is not surgically sterile, must agree to follow the contraceptive guidance (Section 10.14.4) during the treatment period and for at least 90 days after the last dose of the study drug. Cancer-specific Inclusion Criteria Subjects must meet all of the following criteria 1. Have a histologically or cytologically confirmed locally advanced or unresectable or metastatic solid tumor 2. Part B Dose Expansion, Indication F NSCLC: a. Have received no more than 2 prior lines of therapy for locally advanced, recurrent, or metastatic NSCLC. Treatment-na ve subjects who are not eligible for, do not tolerate, or refuse treatment with standard therapy may be enrolled with Sponsor approval. b. Have not received prior immunotherapy for NSCLC (including, but not limited to, anti-PD-1, anti-PD-L1, or anti-cytotoxic t-lymphocyte associated protein 4 (CTLA4) therapies). Note: Inclusion criterion 14 (below) is not applicable to this cohort. c. Must have PD-L1 expression status assessed from a commercially available assay. Subjects with unknown PD-L1 status can be enrolled but must provide archival or fresh tissue for retrospective
Exclusion criteria
Exclusion criteria: General Exclusion Criteria For all cohorts, subjects are excluded from the study if any of the following criteria apply 1. Is 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 2. Women who are pregnant or breastfeeding 3. History of any of the following less than or equal to 6 months prior to the first dose: a. Congestive heart failure New York Heart Association Grade greater than or equal to 2 b. Unstable angina c. Myocardial infarction d. Unstable symptomatic ischemic heart disease e. Uncontrolled hypertension despite appropriate medical therapy f. Ongoing untreated symptomatic cardiac arrhythmias of greater than Grade 2 g. QTcF greater than 470 ms on screening ECG or congenital long QT syndrome h. Pulmonary embolism i. Symptomatic cerebrovascular events j. Any other serious cardiac condition (eg. significant pericardial effusion or restrictive cardiomyopathy); chronic atrial fibrillation on stable anticoagulant therapy is allowed k. Active and clinically significant bacterial, fungal, or viral infection, including known Hepatitis B or C virus (HBV or HCV, testing not required), or human immunodeficiency virus or acute or chronic infection of Coronavirus Disease 2019 (COVID-19) as determined by polymerase chain reaction or antigen test Note: subjects whose HIV, HBV, or HCV infection is controlled by antiviral therapy should not be excluded. 4. Any contraindications to the imaging assessments or other study procedures that subjects will undergo 5. 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 Exclusion Criteria For all cohorts, subjects are excluded from the study if any of the following criteria apply: 1. Current second malignancy at other sites a. Exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma (eg. cervical), or indolent prostate cancer under observation. A history of other malignancies is allowed as long as the subject is free of recurrence for greater than or equal to 3 years. 2. Leptomeningeal disease 3. Spinal cord compression 4. Symptomatic or new or enlarging central nervous system (CNS) metastases a. Asymptomatic CNS disease must be treated and stable on imaging by magnetic resonance imaging scan within 28 days of study treatment in order to be eligible for this study. Treatment-specific Exclusion Criteria 1. Subject has ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (Grade 2 sensory neuropathy and Grade 2 alopecia are allowed). 2. Has undergone a major surgery (excluding minor procedures, e.g., placement of vascular access) 3. Part A Enrichment: Has received more than 3 prior lines of anticancer treatment in the metastatic setting. For subjects with CRPC, androgen deprivation therapies will not be counted as separate lines of anticancer treatment in determining eligibility per Section 8.2.3 Criterion 3. 4. Part B Dose Expansion, Indication F NSCLC: Subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the antitumor activity of GIM-122 as a single agent in subjects with PD-1/ PD-L1 refractory/resistant advanced solid tumor malignancies.Timepoint: Week 1-3, 4-6, 7-9, onward up to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability To characterize the PK profile of GIM-122 To assess the emergence and persistence of anti-drug antibodies (ADA) and the impact on GIM-122 exposure To assess the change from baseline in tumor tissue biomarkers as potential predictors of efficacy of GIM-122 Timepoint: Week 1-3, 4-6, 7-9, onward up to 12 months. | — |
Countries
India, United States of America
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research
Outcome results
None listed