A Study of AK138D1 in Advanced Malignant Tumors

NCT ID: NCT07281326

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2028-05-30

Brief Summary

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.

Detailed Description

This open-label, dose-escalation and expansion Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of AK138D1 in subjects with advanced malignant tumors. The study will test different doses of AK138D1 to find the recommended dose for future studies and assess whether the drug shows signs of effectiveness against cancer. Participants will receive AK138D1 through intravenous infusion and will be closely monitored for side effects and treatment response. The final number of participants enrolled will depend on the safety and effectiveness results observed during the study.

Conditions

Solid Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK138D1

AK138D1 will be administered in pre-specified dose levels.

Group Type: EXPERIMENTAL

AK138D1

Intervention Type: DRUG

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

Interventions

AK138D1

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subject must sign the written informed consent form (ICF) voluntarily;

2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;

3. ECOG performance status score of 0 or 1;

4. Has a life expectancy of ≥ 3 months;

5. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.

6. Adequate organ function.

Exclusion Criteria

1. Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;

2. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;

3. Presence of active central nervous system (CNS) metastases.

4. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;

5. Untreated subjects with active hepatitis B or active hepatitis C;

6. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;

7. Known active syphilis infection;

8. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;

9. Other reasons for ineligibility as evaluated by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenting Li, MD

Role: STUDY_DIRECTOR

Akeso

Locations

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenting Li, MD

Role: CONTACT

clinicaltrials@akesobio.com

+86(0760)89873999

Facility Contacts

Tongsen Zheng, MD

Role: primary

Other Identifiers

AK138D1-102

Identifier Type: -

Identifier Source: org_study_id