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Safety of AM-928 Infusion in Advanced Solid Tumors

NCT05687682 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-28

No results posted yet for this study

Summary

This is a Phase I, open-label, dose-escalation study for a novel cancer treatment, AM-928, intravenous infusion antibody for advanced solid tumor. The study is aimed to learn the safety, tolerability, pharmacokinetics, and preliminary efficacy profile of AM-928.

The dose escalation strategy will adopt accelerated titration combined with a Bayesian optimal interval (BOIN) design. Seven dose levels are designed and each participant will be assigned to a specific dose regimen depending on the time of enrollment. In the study, each participant will receive AM-928 treatment cycles till meeting any treatment discontinuation criterion and be followed for safety and long-term survival.

The whole study is expected to take approximately three years to complete.

Conditions

  • Advanced Solid Tumor

Interventions

BIOLOGICAL

AM-928

AM-928, which is a humanized anti-EpCAM monoclonal antibody developed by AcadeMab Biomedical Inc.

Sponsors & Collaborators

  • AcadeMab Biomedical Inc.

    lead INDUSTRY

Principal Investigators

  • Pi-Chun Li, Ph.D. · AcadeMab Biomedical Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Taiwan

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 NCT05687682 on ClinicalTrials.gov