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
Qualifiers
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
Treatments tested in this trial
- GIM122
Treatment groups
111 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov