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)

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)
• Colorectal Cancer (CRC)
• HER2 Negative Breast Cancer
• Cutaneous Melanoma
• Renal 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• GI Innovation, Inc.

  lead INDUSTRY

Principal Investigators

• Nari Yun, PhD · GI Innovation, Inc.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-30

Primary Completion

2025-11-12

Completion

2027-04-24

FDA Drug

Yes

Countries

• United States
• South Korea

Study Locations