NCT06730386

A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors

A First-in-human, Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK138D1 in the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.

Detailed description

This study is comprised of two parts: the dose-escalation and dose-expansion stages. Dose-escalation stage aims to determine the MTD/MAD, while the dose-expansion stage is designed to establish the RP2D.

Conditions

• Solid Cancer

Interventions

Type	Name	Description
DRUG	AK138D1	Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.

Timeline

• Start date: 2025-02-24
• Primary completion: 2028-02-26
• Completion: 2028-08-30
• First posted: 2024-12-12
• Last updated: 2025-03-06

Locations

4 sites across 1 country: Australia