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Phase I Study of Single-Agent KGX105 in Patients With Advanced or Metastatic Solid Tumors

NCT07702955 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-07-21

No results posted yet for this study

Summary

This is a first-in-human, open-label, multicenter, Phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary antitumor activity of single-agent KGX105 in participants with locally advanced or metastatic solid tumors. The study consists of two parts: Phase 1a dose escalation and Phase 1b dose expansion.

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

DRUG

KGX105 injection

KGX105 is an investigational EGFR×CD3 TCE prodrug engineered with masked binding domains to reduce on-target, off-tumor toxicity and systemic activation. It is selectively activated in the tumor microenvironment (TME) to target EGFR-positive tumors. An integrated albumin-binding domain prolongs systemic half-life, optimizing drug exposure and efficacy.KGX105 injection is a sterile, white or slightly yellow lyophilized powder, supplied at 10.0 mg/vial for single use.

Sponsors & Collaborators

  • Kangabio AUSTRALIA LTD PTY

    lead INDUSTRY

Principal Investigators

  • Li Zhang · Sun Yat-Sen University Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-09-30
Completion
2028-11-30

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 NCT07702955 on ClinicalTrials.gov