A Study of AK138D1 in Advanced Malignant Tumors

A Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AK138D1 in Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Cancer
• Intervention / Treatment: Drug: AK138D1

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wenting Li, MD; Phone Number: +86(0760)89873999; Email: clinicaltrials@akesobio.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Tongsen Zheng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK138D1; AK138D1 will be administered in pre-specified dose levels.	Drug: AK138D1; Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Incidence and severity of participants with adverse events	Up to approximately 2 years
Dose-Limiting Toxicity (DLT)	Occurrence of DLTs and determination fo maximum tolerated dose (MTD)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-drug antibodies (ADA)	Number of subjects with detectable anti-drug antibodies (ADA).	Up to approximately 2 years
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1	ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.	Up to approximately 2 years
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1	Disease control rate (DCR) assessed according to RECIST v1.1.	Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1	Duration of response (DoR) assessed according to RECIST v1.1.	Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1	Time to response (TTR) is defined as the time to response based on RECIST v1.1.	Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1	PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.	Up to approximately 2 years
Overall Survival (OS)	Overall Survival (OS) is defined as the time from randomization to death due to any cause.	Up to approximately 2 years
Peak Plasma Concentration (Cmax) of AK138D1	AK138D1 serum drug concentrations in subjects at different time points after administration.	Up to approximately 2 years
Area under the plasma concentration versus time curve (AUC) of AK138D1	The definite integral of the concentration of AK138D1 in blood plasma as a function of time.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Akeso
• Investigators: Study Director: Wenting Li, MD, Akeso

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AK138D1-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No