Status:
RECRUITING
A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors
Lead Sponsor:
Akeso
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advanced solid tumors...
Eligibility Criteria
Inclusion
- Be able to understand and voluntarily sign the written informed consent form.
- Aged of ≥ 18 years and ≤75 years.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
- At least one measurable lesion according to RECIST v1.1.
- Have sufficient organ function.
- Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception
Exclusion
- Having other active malignancies within 3 years.
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- Having received any treatment targeting Trop2 or Nectin4 or any treatment with topoisomerase I inhibitor agents.
- 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.
- Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
- Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
- Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
- Known to be positive for HIV and other infections.
- Previous history of severe hypersensitivity reactions.
- Live attenuated vaccines were received within 4 weeks.
- Subjects with a history of mental illness and incapacitated or limited capacity.
- Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 5 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06929663
Start Date
July 2 2025
End Date
May 5 2027
Last Update
July 17 2025
Active Locations (1)
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1
Scientia Clinical Research
Sydney, New South Wales, Australia