AK146D1 injection for adults with advanced solid tumors

A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 for Injection, an Anti-Trop2/Nectin4 Bispecific Antibody-drug Conjugate, in Patients With Advanced Solid Tumors

This trial will try an experimental injection called AK146D1 in adults with advanced solid tumors that have progressed after standard treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT06929663 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, Phase 1 interventional study of AK146D1 given by injection to adults with unresectable advanced solid tumors. The trial will enroll patients with measurable disease and good performance status (ECOG 0-1) who have progressed on or are intolerant of standard therapies, and will monitor safety, tolerability, pharmacokinetics, immunogenicity, and early signs of antitumor activity. Response will be measured using RECIST v1.1 and participants must have adequate organ function and agree to contraception if applicable. Patients with active central nervous system metastases or recent other active malignancies are excluded unless specified as stable or asymptomatic.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with histologically confirmed unresectable advanced solid tumors that progressed after or have no standard treatment, an ECOG performance status of 0–1, at least one measurable lesion, and adequate organ function.

Not a fit: Patients with poor performance status (ECOG >1), active or uncontrolled brain metastases, recent other active malignancies, or who previously received therapies targeting Trop2 or Nectin4 are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If successful, AK146D1 could become a new treatment option that shrinks tumors or slows disease in some patients with advanced solid tumors.

How similar studies have performed: Other antibody-drug conjugates and targeted agents against Trop2 or Nectin4 have produced responses in certain cancers, but AK146D1 is being tested in humans for the first time and its safety and effectiveness are unproven.

Eligibility criteria

Inclusion Criteria:

1. Be able to understand and voluntarily sign the written informed consent form.
2. Aged of ≥ 18 years and ≤75 years.
3. ECOG PS 0 or 1.
4. The expected lifespan is ≥3 months.
5. Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
6. At least one measurable lesion according to RECIST v1.1.
7. Have sufficient organ function.
8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception

Exclusion Criteria:

1. Having other active malignancies within 3 years.
2. Currently participating in another interventional clinical study.
3. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
4. Having received any treatment targeting Trop2 or Nectin4 or any treatment with topoisomerase I inhibitor agents.
5. Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration.
6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
7. Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
8. Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
9. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
10. Known to be positive for HIV and other infections.
11. Previous history of severe hypersensitivity reactions.
12. Live attenuated vaccines were received within 4 weeks.
13. Subjects with a history of mental illness and incapacitated or limited capacity.
14. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

Where this trial is running

Sydney, New South Wales

• Scientia Clinical Research — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Hui Gan — Austin Health
• Study coordinator: Ting Liu

Conditions Advanced Solid Tumors