Actively Recruiting
A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors
Led by Akeso · Updated on 2025-03-06
100
Participants Needed
4
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.
CONDITIONS
Official Title
A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent voluntarily
- Aged 18 to 75 years, any gender
- ECOG performance status score of 0 or 1
- Life expectancy of 3 months or more
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor refractory or intolerant to standard treatment
- At least 1 measurable lesion suitable for accurate repeated measurement per RECIST v1.1
- Adequate organ function
You will not qualify if you...
- Prior HER3-targeted therapies, including antibodies, ADCs, CAR-T, or others
- Participation in other interventional clinical studies, except non-interventional or follow-up periods
- Active central nervous system metastases
- History of non-infectious pneumonitis requiring systemic corticosteroids or interstitial lung disease, or current/presumed ILD/pneumonitis
- Live or attenuated live vaccines within 4 weeks before first dose or planned during study (inactivated vaccines allowed)
- Active hepatitis B or C infection not controlled by therapy
- Known active pulmonary tuberculosis or suspected active TB without assessment
- Active syphilis infection
- Known allergy to any study drug components or history of severe hypersensitivity to monoclonal antibodies
- Other ineligibility reasons as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Blacktown Hospital-Blacktwon Cancer and Haematology Centre
Blacktown, New South Wales, Australia, 2148
Not Yet Recruiting
2
Macquarie University
North Ryde, New South Wales, Australia, 2109
Not Yet Recruiting
3
ICON Cancer Centre South Brisbane
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
4
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
Research Team
W
Wenting Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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