AK138D1 for advanced solid tumors

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

We will try AK138D1 given by IV in adults with advanced solid tumors that haven't responded to standard treatments to find a safe dose and see if it can shrink tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (industry)
• Drugs / interventions: CAR-T, chimeric antigen receptor, immunotherapy
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT07281326 on ClinicalTrials.gov

What this trial studies

This open-label Phase I trial uses dose-escalation followed by expansion cohorts to determine the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of AK138D1 in adults with advanced solid tumors. Participants will receive AK138D1 by intravenous infusion at escalating dose levels to identify a recommended dose for future studies. Patients will be closely monitored for side effects, blood drug levels, immune responses, and tumor responses by imaging using RECIST v1.1. Up to 200 patients may be enrolled, with final numbers depending on safety and early efficacy findings.

Who should consider this trial

Good fit: Adults aged 18–75 with measurable advanced solid tumors, ECOG 0–1, adequate organ function, and at least a three-month life expectancy who have exhausted standard treatments are the ideal candidates.

Not a fit: Patients with active CNS metastases, prior HER3-targeted therapies, or who cannot meet safety requirements or attend the study site are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, AK138D1 could provide a new treatment option that controls tumor growth for some patients whose cancers no longer respond to standard therapies.

How similar studies have performed: HER3-targeted antibodies and other targeted agents have shown occasional responses in early-phase trials for select tumors, but overall clinical benefit remains limited and investigational.

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. 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.

Where this trial is running

Harbin, Heilongjiang

• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)

Study contacts

• Study coordinator: Wenting Li, MD

Conditions: Solid Cancer