Actively Recruiting
A Phase I Study Evaluating Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK138D1 in Advanced Solid Tumors
Led by Akeso · Updated on 2025-12-15
200
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AK138D1 in a Phase I clinical trial involving patients with advanced malignant tumors who have not responded to standard treatments. This study aims to assess the safety, tolerability, immune response, and possible anti-tumor effects of AK138D1 to find the best dose for future research. The trial focuses on adults up to 75 years old with measurable cancer lesions and good overall health status. Participants will receive AK138D1 through intravenous infusion at specified dose levels. The study includes a dose-escalation phase to identify the safest and most effective dose. Patients will be closely monitored during treatment for any side effects and responses. The number of participants will depend on observed safety and effectiveness results. During the trial, participants will undergo assessments such as imaging scans to measure tumor size, blood tests to monitor drug levels and immune response, and evaluations of side effects. The primary outcomes include tracking adverse events and dose-limiting toxicities over about two years. Secondary outcomes observe drug concentration, immune reactions, tumor response rates, disease control, survival times, and overall patient survival. Careful monitoring ensures participant safety throughout the study period.
CONDITIONS
Brief Title
A Study of AK138D1 in Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent voluntarily
- Age 18 to 75 years, male or female
- ECOG performance status score of 0 or 1
- Life expectancy of at least 3 months
- At least 1 measurable lesion suitable for repeated measurement per RECIST v1.1
- Adequate organ function
You will not qualify if you...
- Prior HER3-targeted therapies including antibodies, ADCs, or CAR-T
- Participation in another interventional clinical study concurrently
- Active central nervous system metastases
- Live or attenuated live vaccines within 4 weeks before first dose or planned during study
- Active untreated hepatitis B or C
- Known active pulmonary tuberculosis
- Known active syphilis infection
- Allergy to any study drug component or severe hypersensitivity to monoclonal antibodies
- Other reasons judged by investigator making the participant ineligible
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 dosing cohort and are closely monitored for side effects and treatment response.
Multiple visits for infusions and monitoring over the treatment period
Trial Site Locations
Total: 1 location
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
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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