Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

Inclusion Criteria:

General

• Written informed consent

• ECOG performance status 0-1.

• Laboratory assessment 28 days prior to enrollment for assessment of acceptablecardiac, renal and hepatic functions

• Recommended Double methods of contraception 90-days post treatment Cancer Specific

• Histologically or cytologically confirmed locally advanced/unresectable ormetastatic solid tumor

• Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advancemalignant 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 thefirst dose of GIM-122 and throughout the duration of the study, or is receivingother therapy directed at their malignancy

• Women who are pregnant or breastfeeding

• History of cardiac issues, pulmonary embolism, active and clinically significantbacterial, fungal, or viral infection ≤ 6 months prior to dosing

• Contraindications to the imaging assessments or other study procedures that subjectswill undergo or any medical or social condition that, in the opinion of theinvestigator, might place a subject at an increased risk, affect compliance, orconfound 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 Exclusion Criteria

• Ongoing toxicity > Grade 1 from prior therapy according to Common TerminologyCriteria for Adverse Events (CTCAE) v 5.0

• Has undergone a major surgery < 1 month prior to administration of GIM-122

• Has received radiation therapy within 2 weeks prior to administration of GIM-122

• Has undergone or is anticipated to undergo organ transplantation includingallogeneic or autologous stem cell transplantation at any time

• Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents thathave a major delayed toxicity within 4 weeks, of the first dose of GIM-122

• Prior treatment with other immune modulating agents within < 4 weeks prior to thefirst dose of GIM-122.

• Has a diagnosis of immunodeficiency, either primary or acquired

• Has received treatment with systemic steroids or any form of immunosuppressivetherapy within 14 days prior to administration of GIM-122

• Has active or prior history of autoimmune disease, including ulcerative colitis andCrohn's disease, or any condition that requires systemic steroids.

• Has a known severe intolerance to or hypersensitivity reactions to monoclonalantibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history ofhuman anti-human antibody response; known allergy to any of the study medications,or excipients in the various formulations of any agent.

• Has received live vaccines within 30 days of study initiation (inactivated vaccinesare allowed; seasonal vaccines should be up to date > 30 days prior toadministration of GIM-122).