Testing AK138D1 for advanced solid tumors

A First-in-human, Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK138D1 in the Treatment of Advanced Solid Tumors

This study is testing a new treatment called AK138D1 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: CAR-T, chimeric antigen receptor, immunotherapy, radiation
• Locations: 4 sites (Blacktown, New South Wales and 3 other locations)
• Trial ID: NCT06730386 on ClinicalTrials.gov

What this trial studies

This open-label, first-in-human Phase I clinical study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of AK138D1 in patients with advanced solid tumors. The study consists of two parts: a dose-escalation stage to determine the maximum tolerated dose (MTD) and a dose-expansion stage to establish the recommended Phase II dose (RP2D). Participants will be closely monitored for responses and side effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced solid tumors that are refractory to or intolerant of standard treatments.

Not a fit: Patients with active central nervous system metastases or those who have previously received HER3-targeted therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting advanced solid tumors have shown promise in the past.

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.

Where this trial is running

Blacktown, New South Wales and 3 other locations

• Blacktown Hospital-Blacktwon Cancer and Haematology Centre — Blacktown, New South Wales, Australia (Not_yet_recruiting)
• Macquarie University — North Ryde, New South Wales, Australia (Not_yet_recruiting)
• ICON Cancer Centre South Brisbane — South Brisbane, Queensland, Australia (Recruiting)
• Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Wenting Li, MD

Conditions Solid Cancer