# 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)

> **NCT05824975** · PHASE1,PHASE2 · RECRUITING · sponsor: **GI Innovation, Inc.** · enrollment: 358 (estimated)

## Conditions studied

- 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)
- **DRUG:** GI-102
- **DRUG:** doxorubicin
- **DRUG:** paclitaxel
- **DRUG:** bevacizumab
- **DRUG:** eribulin
- **DRUG:** trastuzumab deruxtecan (T-DXd)
- **DRUG:** pembrolizumab
- **DRUG:** GI-102

## Key facts

- **NCT ID:** NCT05824975
- **Lead sponsor:** GI Innovation, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-05-30
- **Primary completion:** 2025-11-12
- **Final completion:** 2027-04-24
- **Target enrollment:** 358 (ESTIMATED)
- **Last updated:** 2024-11-25

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05824975

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT05824975. Licensed CC0.

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