# A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizu

Source: https://onco.cc/trials/nct05824975/  
OnCo record `nct05824975` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Doxorubicin, Paclitaxel / nab-paclitaxel, Bevacizumab in sarcomas and ovarian cancer, run by GI Innovation, Inc., now recruiting.

## Summary

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) is a phase 1/2 interventional study registered as NCT05824975 by GI Innovation, Inc., with 358 participants planned, started 2023-05-30 and due to reach its primary completion in 2025-11-12. Interventions recorded: GI-102 subcutaneous (SC), GI-102, doxorubicin, paclitaxel, bevacizumab. Conditions listed: Advanced Solid Tumor, Metastatic Solid Tumor, Soft Tissue Sarcoma (STS), Platinum-resistant Ovarian Cancer (PROC). No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT05824975
- Phase: 1/2
- Setting: An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)
- Sponsor: GI Innovation, Inc.
- Enrolled: 358

## Sources

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

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/), [Melanoma](https://onco.cc/cancers/melanoma/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Sarcomas (soft tissue, bone, GIST)](https://onco.cc/cancers/sarcoma/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Eribulin](https://onco.cc/drugs/eribulin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)

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