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

Last updated: March 4, 2025
Sponsor: Akeso
Overall Status: Active - Recruiting

Phase

1

Condition

All Solid Tumors

Treatment

AK138D1

Clinical Study ID

NCT06730386
AK138D1-101
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ormetastatic 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 repeatedaccurate measurement.

  7. Adequate organ function.

Exclusion

Exclusion Criteria:

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

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

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

  4. Patients with a history of non-infectious pneumonitis requiring systemiccorticosteroid therapy; a history of interstitial lung disease (ILD) (includingpulmonary fibrosis or radiation pneumonitis); currently suffering fromILD/pneumonitis or suspected of having such diseases based on imaging duringscreening;

  5. Live vaccines or attenuated live vaccines administered within 4 weeks prior to thefirst dose, or planned to be administered during the study; use of inactivatedvaccines 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). ForHBsAg-positive subjects, anti-hepatitis B therapy is required during the study;subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above thelower limit of detection) is also an exclusion;

  7. Known active pulmonary tuberculosis (TB); subjects with suspected active TB mustundergo 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 historyof known severe hypersensitivity reactions to other monoclonal antibodies;

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: AK138D1
Phase: 1
Study Start date:
February 24, 2025
Estimated Completion Date:
August 30, 2028

Study 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.

Connect with a study center

  • Blacktown Hospital-Blacktwon Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Macquarie University

    North Ryde, New South Wales 2109
    Australia

    Site Not Available

  • ICON Cancer Centre South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

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