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)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
GI Innovation, Inc.
Study ID
NCT05824975
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Colorectal Cancer (CRC)
  • Cutaneous Melanoma
  • HER2 Negative Breast Cancer
  • Hepatocellular Carcinoma (HCC)
  • Metastatic Solid Tumor
  • Platinum-resistant Ovarian Cancer (PROC)
  • Renal Cell Carcinoma (RCC)
  • Soft Tissue Sarcoma (STS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GI-102 subcutaneous (SC) — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks.
  • eribulin — DRUG
    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) — DRUG
    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 — DRUG
    pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
  • GI-102 — DRUG
    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).

Study Details

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.

Key Dates

Start date
May 30, 2023
Status verified
Nov 2024
Primary completion
Nov 12, 2025
Completion
Apr 24, 2027

Study Design

Enrollment
358 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Mahesh Seetharam, MD
Mayo Clinic in FloridaJacksonvilleFlorida32224
Yujie Zhao, MD, PhD
Mayo Clinic in MinnesotaRochesterMinnesota55905
Jian Li Campian, MD, PhD
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065
Viswatej Avutu, MD
Cleveland ClinicClevelandOhio44195
Wen Wee Ma, MBBS

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Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Minnesota· Rochester, MNMemorial Sloan-Kettering Cancer Center· New York, NYCleveland Clinic· Cleveland, OH

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