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)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

358

Participants

Timeline

Start Date

May 30, 2023

Primary Completion Date

November 12, 2025

Study Completion Date

April 24, 2027

Conditions
Advanced Solid TumorMetastatic Solid TumorSoft Tissue Sarcoma (STS)Platinum-resistant Ovarian Cancer (PROC)Hepatocellular Carcinoma (HCC)Colorectal Cancer (CRC)HER2 Negative Breast CancerCutaneous MelanomaRenal Cell Carcinoma (RCC)
Interventions
DRUG

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).

DRUG

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).

DRUG

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.

DRUG

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.

DRUG

bevacizumab

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

DRUG

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.

DRUG

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.

DRUG

pembrolizumab

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

DRUG

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).

Trial Locations (11)

10065

RECRUITING

Memorial Sloan-Kettering Cancer Center, New York

12647

RECRUITING

St. Vincent's Hospital, Suwon

32224

RECRUITING

Mayo Clinic in Florida, Jacksonville

44195

RECRUITING

Cleveland Clinic, Cleveland

55905

RECRUITING

Mayo Clinic in Minnesota, Rochester

85259

RECRUITING

Mayo Clinic in Arizona, Scottsdale

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Yonsei University Health System, Severance Hospital, Seoul

RECRUITING

Yonsei University Health System, Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

GI Innovation, Inc.

INDUSTRY

NCT05824975 - 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) | Biotech Hunter | Biotech Hunter