Actively Recruiting
A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors
Led by Akeso · Updated on 2025-07-17
48
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the written informed consent form
- Aged between 18 and 75 years
- ECOG performance status of 0 or 1
- Expected lifespan of at least 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
- Adequate organ function
- Female participants must not be pregnant at screening or have evidence of non-childbearing potential and agree to use medically accepted contraception methods
You will not qualify if you...
- Other active malignancies within the past 3 years
- Currently participating in another interventional clinical study
- Active metastases to the central nervous system, except for asymptomatic or stable brain metastases after treatment
- Previous treatment targeting Trop2 or Nectin4 or with topoisomerase I inhibitor agents
- Systemic anti-tumor treatment within 4 weeks or 1 cycle interval before first dose or major surgery within 4 weeks before first dose
- Unresolved toxicity from previous anticancer therapy above Grade 1 per NCI CTCAE 5.0
- Clinically significant cardiovascular or cerebrovascular diseases or risks
- Active autoimmune diseases requiring systemic treatment within 2 years
- Active infection needing antibodies treatment within 2 weeks or severe infection within 4 weeks prior to first dose
- Known positive for HIV or other infections
- History of severe hypersensitivity reactions
- Receipt of live attenuated vaccines within 4 weeks
- History of mental illness with incapacity or limited capacity
- Any condition compromising safety or study assessments as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Scientia Clinical Research
Sydney, New South Wales, Australia
Actively Recruiting
Research Team
T
Ting Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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