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A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors

NCT07376707 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-01-29

No results posted yet for this study

Summary

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors.

The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).

Conditions

  • CRC (Colorectal Cancer)
  • Melanoma (Skin Cancer)
  • HCC - Hepatocellular Carcinoma
  • NSCLC (Non-small Cell Lung Cancer)

Interventions

DRUG

TGI-5

Subjects will receive TGI-5 as monotherapy in Phase 1a by Q2W for 28-day cycles. Subjects will receive TGI-5 in combination with Nivolumab in Phase 1b by Q2W for 28-day cycles.

Sponsors & Collaborators

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Hefei TG ImmunoPharma Co., Ltd.

    lead OTHER

Principal Investigators

  • Hongxia Wang, Doctorate · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07376707 on ClinicalTrials.gov