A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation with Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor activity of GIM-122 as a Single Agent in Adult 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 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 Exclusion Criteria

- Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology

Criteria 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 including

allogeneic or autologous stem cell transplantation at any time

- Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that

have 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 the

first dose of GIM-122.

- Has a diagnosis of immunodeficiency, either primary or acquired

- Has received treatment with systemic steroids or any form of immunosuppressive

therapy within 14 days prior to administration of GIM-122

- Has active or prior history of autoimmune disease, including ulcerative colitis and

Crohn's disease, or any condition that requires systemic steroids.

- Has a known severe intolerance to or hypersensitivity reactions to monoclonal

antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of

human 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 vaccines

are allowed; seasonal vaccines should be up to date > 30 days prior to

administration of GIM-122).