Actively Recruiting
Phase Ia/Ib Clinical Study Evaluating Safety and Preliminary Efficacy of AK127 Combined With AK104 in Advanced Malignant Tumors
Led by Akeso · Updated on 2025-03-03
205
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early effectiveness of two drugs, AK127 and AK104, combined for treating patients with advanced malignant tumors. This Phase Ia/Ib open-label clinical trial focuses on patients whose cancer has progressed despite previous treatments or who are not suitable for standard therapies. The study aims to explore how blocking multiple immune checkpoints simultaneously may improve the body's anti-tumor response. The study includes two main stages: a dose escalation phase with five dose groups of AK127 given every three weeks at increasing doses alongside a fixed dose of AK104, and a dose expansion phase with several patient cohorts representing different tumor types. Both drugs are administered intravenously every three weeks. The trial assesses the combined effect of AK127, a monoclonal antibody targeting TIGIT, and AK104, a bispecific antibody targeting PD-1 and CTLA-4, to potentially enhance immune system activity against tumors. Participants will receive the study drugs intravenously and undergo regular monitoring for up to approximately two years. Researchers will evaluate safety through the frequency and severity of adverse events, including immune-related side effects, and study the drugs' behavior in the body. Effectiveness will be measured by tumor response rates, disease control, survival outcomes, and other pharmacokinetic parameters. The study includes physical exams, laboratory tests, imaging, and ongoing safety assessments throughout the participation period.
CONDITIONS
Brief Title
A Phase Ia/Ib Open Label，Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign the informed consent form.
- Age between 18 and 75 years, male or female.
- ECOG performance status score of 0 or 1.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed advanced, recurrent, or metastatic malignancies.
- Patients failed or are not suitable for first to fourth-line standard therapies.
- At least one measurable lesion suitable for repeated measurement (brain metastases excluded).
- Good organ function.
- Negative serum pregnancy test within 3 days before first medication for women of childbearing age.
- Fertile females must use effective contraception from screening until 6 months after last study drug dose.
- Fertile males must use effective contraception from screening until 6 months after last study drug dose.
You will not qualify if you...
- Use of targeted antitumor drugs, antibodies targeting PD-(L)1, CTLA-4, or TIGIT, or other antitumor therapies within 4 weeks prior to first study drug dose.
- Participation in another clinical study simultaneously.
- Central nervous system metastases with clinical symptoms.
- Other malignancies within 3 years before first medication.
- Active autoimmune disease requiring systemic treatment within 2 years before initial medication.
- Serious disease history within 1 year before first medication.
- History of gastrointestinal perforation, fistula, obstruction, or extensive enterectomy within 6 months prior.
- Recent chest or non-chest radiotherapy exceeding specified doses.
- Live or attenuated vaccine administered within 4 weeks prior to dosing or planned during study.
- Severe infection within 4 weeks prior to first dosing.
- Major surgery or severe trauma within 4 weeks before dosing or planned within 4 weeks after dosing.
- History of severe bleeding or coagulopathy within 4 weeks prior.
- Uncontrolled hypertension or hyperglycemia.
- Pleural, pericardial effusion, or ascites requiring drainage.
- History of noninfectious pneumonia requiring steroids or interstitial lung disease.
- Active inflammatory bowel disease.
- HIV positive or using long-term immunosuppressants.
- History of organ or stem cell transplantation.
- Untreated active hepatitis B or active hepatitis C.
- Unresolved toxicity from prior antitumor therapy above grade 1 (except alopecia and fatigue).
- Known allergy or severe hypersensitivity to study drugs or monoclonal antibodies.
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 AK127 every 3 weeks at varying doses and AK104 at 10 mg/kg every 3 weeks to evaluate safety, tolerability, and preliminary efficacy in advanced malignant tumors.
Infusions every 3 weeks with regular monitoring visits
Duration - Up to approximately 2 years
Participants are monitored for safety, adverse events, and treatment outcomes after the treatment period ends.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
X
Xiao Xu, MD, PhD
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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