Actively Recruiting
A First-in-human, Phase I Study Evaluating Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AK138D1 for Advanced Solid Tumors
Led by Akeso · Updated on 2025-03-06
100
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor effects of AK138D1 in adults with advanced solid tumors. This first-in-human, open-label Phase I trial includes patients whose tumors are resistant or intolerant to standard treatments, aiming to better understand this new drug's potential. The study includes two parts: dose escalation to find the maximum tolerated dose and dose expansion to determine the recommended dose for further research. Participants will receive AK138D1 through intravenous infusions at pre-determined dose levels based on their study group. The first part focuses on gradually increasing doses to identify safe limits, while the second part treats more patients with the recommended dose to further assess safety and early effectiveness. This process helps define appropriate dosing for future studies. During the trial, participants will undergo regular monitoring for side effects and dose-related toxicities for up to two years. Researchers will perform scans and measurements to track tumor response using standard criteria and collect blood samples to study drug levels, immune reactions, and survival outcomes. The study also tracks how long participants respond to treatment and how long they live without disease progression, providing a comprehensive view of safety and preliminary benefits over time.
CONDITIONS
Brief 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, both males and females
- ECOG performance status score of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor refractory or intolerant to standard treatment
- At least 1 measurable lesion per RECIST v1.1 suitable for repeated measurement
- Adequate organ function
You will not qualify if you...
- Prior HER3-targeted therapies including antibodies, ADCs, CAR-T, or others
- Participation in another clinical study except non-interventional or follow-up periods
- Presence of active central nervous system metastases
- History of non-infectious pneumonitis requiring systemic corticosteroids or interstitial lung disease
- Live vaccines within 4 weeks before first dose or planned during study (inactivated vaccines allowed)
- Active hepatitis B or hepatitis C infection
- Known active pulmonary tuberculosis
- Active syphilis infection
- Known allergy to any study drug component or severe hypersensitivity to monoclonal antibodies
- Other investigator-assessed reasons for ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive intravenous infusions of AK138D1 according to their assigned dosing regimen to evaluate safety, tolerability, and preliminary efficacy.
Repeated visits for infusions and assessments during treatment period
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
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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