NCT07281326

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
25mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Oct 2025May 2028

First Submitted

Initial submission to the registry

September 25, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

October 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2026

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

September 25, 2025

Last Update Submit

December 1, 2025

Conditions

Solid Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Peak Plasma Concentration (Cmax) of AK138D1

    Up to approximately 2 years

  • Area under the plasma concentration versus time curve (AUC) of AK138D1

    Up to approximately 2 years

  • Anti-drug antibodies (ADA)

    Up to approximately 2 years

  • Objective Response Rate (ORR) assessed by investigator per RECIST v1.1

    Up to approximately 2 years

  • Disease Control Rate (DCR) assessed by investigator per RECIST v1.1

    Up to approximately 2 years

  • +4 more secondary outcomes

Study Arms (1)

AK138D1

EXPERIMENTAL

AK138D1 will be administered in pre-specified dose levels.

Drug: AK138D1

Interventions

AK138D1DRUG

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

AK138D1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject must sign the written informed consent form (ICF) voluntarily;
  • At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
  • ECOG performance status score of 0 or 1;
  • Has a life expectancy of ≥ 3 months;
  • At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
  • Adequate organ function.

You may not qualify if:

  • 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;
  • Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
  • Presence of active central nervous system (CNS) metastases.
  • 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;
  • Untreated subjects with active hepatitis B or active hepatitis C;
  • Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
  • Known active syphilis infection;
  • Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
  • Other reasons for ineligibility as evaluated by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Study Officials

  • Wenting Li, MD

    Akeso

    STUDY DIRECTOR

Central Study Contacts

Wenting Li, MD

CONTACT

+86(0760)89873999clinicaltrials@akesobio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2025

First Posted

December 15, 2025

Study Start

October 22, 2025

Primary Completion (Estimated)

October 22, 2026

Study Completion (Estimated)

May 30, 2028

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)