Status: Recruiting

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.

Participants needed: 317

Trial details

Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: GI Innovation, Inc.Updated: May 15, 2026Locations: 12

Eligibility criteria

Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory g... [+5]

Has known active CNS metastases and/or carcinomatous meningitis. [+12]

Status: Recruiting

A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors

This Phase 2a clinical study (GIANTS-1) aims to evaluate a novel dual-combination strategy using GI-102 and GIB-7 to address key pathological features of aging, including immunosenescence (the aging of the immune system), metabolic dysfunction, and gut-brain-muscle axis dysregulation.

Participants needed: 15

Trial details

Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: GI Innovation, Inc.Updated: Jan 26, 2026Locations: 2

Eligibility criteria

Must be aged between ≥18 and ≤80 years old at the time of informed consent. [+7]

Severe and poorly managed chronic diseases, such as advanced cardiovascular dise... [+4]

Status: Recruiting

A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors

Participants needed: 76

Trial details

Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: GI Innovation, Inc.Updated: Sep 15, 2025Locations: 3

Eligibility criteria

Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatorygu... [+5]

Has known active CNS metastases and/or carcinomatous meningitis. An active secon... [+5]

Status: Recruiting

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.

Participants needed: 358

Trial details

Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: GI Innovation, Inc.Updated: Nov 25, 2024Locations: 11

Eligibility criteria

Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory g... [+5]

Has known active CNS metastases and/or carcinomatous meningitis. [+12]

Clinical trials

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors

A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors

A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)