A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors

NCT ID: NCT06730386

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2028-08-30

Brief Summary

This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.

Detailed Description

This study is comprised of two parts: the dose-escalation and dose-expansion stages. Dose-escalation stage aims to determine the MTD/MAD, while the dose-expansion stage is designed to establish the RP2D.

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. Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;

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

7. 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. Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;

5. 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;

6. Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion;

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

8. Active syphilis infection;

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

10. 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

Locations

Blacktown Hospital-Blacktwon Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Site Status: NOT_YET_RECRUITING

Macquarie University

North Ryde, New South Wales, Australia

Site Status: NOT_YET_RECRUITING

ICON Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Site Status: RECRUITING

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Wenting Li, MD

Role: CONTACT

wenting01.li@akesobio.com

+86-18116403289

Facility Contacts

Adan Nagrial, MD

Role: primary

adnan.nagrial@health.nsw.gov.au

0288906859

Andrew Parsonson, MD

Role: primary

andrew.parsonson@mqhealth.org.au

0298122956

Jermaine Coward, MD

Role: primary

Jim.Coward@icon.team

0737374500

Vinod Ganju, MD

Role: primary

vg@paso.com.au

0397815244

Other Identifiers

AK138D1-101

Identifier Type: -

Identifier Source: org_study_id