Recruiting
Phase 1
Phase 2

GI-102, Pembrolizumab, T-DXd

Sponsor:

GI Innovation, Inc.

Code:

NCT05824975

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Soft Tissue Sarcoma (STS)

Platinum-resistant Ovarian Cancer (PROC)

Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GI-102 subcutaneous (SC)

GI-102

doxorubicin

paclitaxel

bevacizumab

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Soft Tissue Sarcoma (STS)

Platinum-resistant Ovarian Cancer (PROC)

Hepatocellular Carcinoma (HCC)

Study ID

NCT05824975

Start date

May 30, 2023

Status verified date

Nov, 2024

Completion date

Apr 24, 2027

Anticipated

Primary completion date

Nov 12, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
  • Has adequate organ and marrow function as defined in protocol.
  • Measurable disease as per RECIST v1.1.
  • ECOG performance status 0-1.
  • Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.
  • HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol.

Key Exclusion Criteria:

  • Has known active CNS metastases and/or carcinomatous meningitis.
  • An active second malignancy.
  • Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.
  • Has active tuberculosis or has a known history of active tuberculosis.
  • Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.
  • History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Previous immunotherapies related to mode of action of GI-102.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.
  • Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
  • Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy.
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
  • Known hypersensitivity to any of the components of the drug products and/or excipients of GI-102.

Other protocol defined inclusion exclusion criteria may apply

Study Design

Enrollment

358 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GI-102

Dose escalation: GI-102 intravenous (IV), multiple ascending doses Dose optimization: GI-102 intravenous (IV), sRP2D Dose optimization: GI-102 intravenous (IV), sRP2D-1 (or sRP2D+1)

experimental: GI-102 subcutaneous (SC)

Dose escalation: GI-102 subcutaneous (SC), multiple ascending doses Dose expansion: GI-102 subcutaneous (SC), sRP2D

experimental: GI-102 + doxorubicin

experimental: GI-102 + paclitaxel + bevacizumab

experimental: GI-102 + eribulin

experimental: GI-102 + trastuzumab deruxtecan (T-DXd)

experimental: GI-102 + pembrolizumab

Interventions

GI-102 subcutaneous (SC)

0.12 mg/kg, 0.24 mg/kg or Recommended phase 2 dose of GI-102 will be administered via SC injection Q3W up to 2 years (approximately 35 years).

GI-102

Dose level will be escalated from 0.06 mg/kg to 0.45 mg/kg and Recommended phase 2 dose (or RP2D-1, RP2D+1) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

doxorubicin

Doxorubicin will be administered intravenously at a dose of 75 mg/m2 on Day 3 every 3-week (21-day) cycle for up to 6 cycles.

paclitaxel

Paclitaxel will be administered intravenously over 1 hour at a dose of 80 mg/m2 each time weekly as a diluted solution according to the prescribing information.

bevacizumab

Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks.

eribulin

Eribulin will be administered intravenously at a dose of over 1.4 mg/m2 over 2 to 5 minutes on Days 3 and 10 every 3-week (21-day) cycle.

trastuzumab deruxtecan (T-DXd)

T-DXd will be administered initially as a 5.4 mg/kg (or 6.4 mg/kg only for gastric cancer) IV over 30 - 90 minutes every 3 weeks.

pembrolizumab

pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.

GI-102

Recommended phase 2 dose (or RP2D-1, RP2D-2) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

Primary outcome measure

  • Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B) [ Time Frame: Study Day 1, assessed up to DLT period (3 weeks after treatment) ]
  • Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B) [ Time Frame: Study Day 1, assessed up to approximately 24 months ]
  • Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D) [ Time Frame: Study Day 1, assessed up to approximately 24 months ]

Central Contacts and Locations

Central contacts

Jay Kim

+82-2-404-2003Clinical-102@gi-innovation.com

Woosun Lee

+82-2-404-2003Clinical-102@gi-innovation.com

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Mayo Clinic in Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

GI Innovation, Inc.

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Keywords

  • GI-102
  • CD80-IgG4 Fc-IL2 variant
  • Immunotherapy
  • IL-2
  • Interleukin-2
  • bispecific protein
  • immunocytokine
  • CD80
  • CTLA-4
  • Pembrolizumab
  • T-DXd
  • Trastuzumab deruxtecan
  • Doxorubicin
  • Paclitaxel
  • Bevacizumab
  • Eribulin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GI Innovation, Inc. on 2024-11-25.