Actively Recruiting
A Study of AK131 in Patients With Advanced Solid Tumors
Led by Akeso · Updated on 2024-01-17
130
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients
CONDITIONS
Official Title
A Study of AK131 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent is required.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed unresectable advanced or metastatic malignant tumor that has failed or is intolerant to standard therapy, or no effective standard therapy exists.
- At least one measurable lesion according to RECIST Version 1.1.
- Adequate organ function.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 120 days after the last dose.
You will not qualify if you...
- Any other malignancy within the past 3 years except radically cured local cancers.
- Participation in another clinical study with treatment, except observational or follow-up studies.
- Prior treatment with any anti-CD73 therapy.
- Received anticancer therapy within 4 weeks before the first dose of the study drug.
- Previous immunotherapy causing permanent discontinuation due to toxicity.
- Spinal cord compression or active brain metastases, except untreated asymptomatic or stable brain metastases.
- Pleural, pericardial effusion, or ascites requiring repeated drainage.
- Tumor invading important blood vessels or high risk of fatal bleeding.
- Unresolved toxicities from prior anticancer therapy greater than Grade 1.
- Significant cardio-cerebrovascular disease.
- Active or history of autoimmune diseases that may relapse.
- History of interstitial lung disease or noninfectious pneumonitis.
- Major surgery, trauma, unhealed wound, ulcer, or fracture within 4 weeks before first dose.
- Required systemic corticosteroids or immunosuppressive treatment within 14 days before first dose.
- Received live attenuated vaccines within 4 weeks before first dose.
- Known allergy to any component of AK131.
- Previous organ or allogeneic hematopoietic stem cell transplantation.
- Other conditions that may interfere with study evaluation or safety as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jinming Yu
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
T
Ting Liu, MD
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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