Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07281326

A Study of AK138D1 in Advanced Malignant Tumors

Led by Akeso · Updated on 2025-12-15

200

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase I clinical trial testing the safety and effectiveness of AK138D1in patients with advanced cancer. The study will enroll up to 200 patients with various types of advanced solid tumors who haven't responded to standard treatments. Patients will receive AK138D1 to determine the safest dose and evaluate if the drug can help treat their cancer.

CONDITIONS

Official Title

A Study of AK138D1 in Advanced Malignant Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent form voluntarily
  • Age between 18 and 75 years, male or female
  • ECOG performance status score of 0 or 1
  • Life expectancy of at least 3 months
  • At least 1 measurable lesion suitable for repeated measurement
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Prior HER3-targeted therapies, including antibodies, ADCs, or CAR-T
  • Participation in another interventional clinical study concurrently
  • Active central nervous system (CNS) metastases
  • Live or attenuated vaccines administered within 4 weeks before first dose or planned during study
  • Untreated active hepatitis B or C
  • Known active pulmonary tuberculosis
  • Known active syphilis infection
  • Allergy to any study drug components or severe hypersensitivity to other monoclonal antibodies
  • Other ineligibility reasons as determined by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Actively Recruiting

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Research Team

W

Wenting Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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