Actively Recruiting
A Study of AK146D1 for Injection in Advanced Solid Tumors
Led by Akeso · Updated on 2025-09-03
200
Participants Needed
1
Research Sites
90 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 Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the 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 progression or intolerance to standard treatment or no available standard treatment
- At least one measurable lesion according to RECIST v1.1 criteria
- Sufficient organ function
- Female participants must not be pregnant at screening or be non-childbearing and agree to use medically accepted contraception methods
You will not qualify if you...
- Other active cancers within the past 3 years
- Currently participating in another interventional clinical study
- Active central nervous system metastases (except asymptomatic or stable brain metastases after treatment)
- Previous treatment targeting Trop2 or Nectin4
- Systemic anti-tumor treatment or major surgery within 4 weeks before first dose
- Unresolved toxicity from previous cancer therapy above grade 1 (NCI CTCAE 5.0)
- Significant cardiovascular or cerebrovascular diseases or risks
- Active autoimmune diseases requiring systemic treatment within 2 years
- Active infection requiring antibiotic treatment within 2 weeks or severe infection within 4 weeks before first dose
- Known positive for HIV or other infections
- History of severe hypersensitivity reactions
- Live attenuated vaccines within 4 weeks
- History of mental illness with incapacitated or limited capacity
- Any condition that may compromise safety or interfere with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SunYat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
T
Ting Liu
CONTACT
L
Li Zhang, Study Principal Investigator
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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