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Clinical trial

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)

NCT05824975 is registered in ClinicalTrials.gov with GI Innovation, Inc. as lead sponsor.

NCT NCT05824975
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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
GI Innovation, Inc.
Phase
Phase 1/2
Overall status
Recruiting
Start date
May 30, 2023
Completion date
April 24, 2027
Enrollment
358 (estimated)
Sites
11

Conditions

As the registry lists them; a condition with its own page is linked.

advanced solid tumor, colorectal cancer (crc), cutaneous melanoma, hepatocellular carcinoma (hcc), her2 negative breast cancer, metastatic solid tumor, platinum-resistant ovarian cancer (proc), renal cell carcinoma (rcc), soft tissue sarcoma (sts)