Actively Recruiting
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
Led by Akeso · Updated on 2025-03-03
205
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Signed written informed consent form voluntarily
- Aged 18 to 75 years, male or female at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced, recurrent, or metastatic malignancies
- For phase Ia: patients with advanced metastatic malignancies who have failed or are not suitable for standard therapies
- At least one measurable lesion per RECIST v1.1, excluding brain metastases
- Good organ function
- Negative serum pregnancy test within 3 days before first medication for females of childbearing potential
- Use of effective contraception from screening through 6 months after last drug administration for fertile female subjects and unsterilized male subjects
You will not qualify if you...
- Use of small-molecule targeted antitumor drugs, monoclonal or bispecific antibodies targeting PD-(L)1 or CTLA-4, other anti-tumor antibodies, or other anti-tumor therapies within 4 weeks prior to study drug administration
- Use of immunomodulatory drugs within 2 weeks prior to first study drug administration
- Prior treatment with TIGIT, PVRIG, or CD96 antibodies
- Participation in another clinical study at the same time
- Central nervous system metastases with clinical symptoms
- Other malignancies within 3 years prior to first medication
- Active autoimmune disease requiring systemic treatment within 2 years prior to first medication
- History of serious disease within 1 year before first medication
- History of gastrointestinal perforation, fistula, obstruction, or extensive enterectomy within 6 months prior to first administration
- Recent high-dose radiotherapy or palliative radiotherapy within specified timeframes before first drug use
- Live or attenuated vaccine use within 4 weeks prior to first administration or planned during study
- Severe infection within 4 weeks prior to dosing
- Major surgery or severe trauma within 4 weeks prior to dosing or planned within 4 weeks after dosing
- History of severe bleeding tendency or coagulopathy within 4 weeks prior to dosing
- Uncontrolled hypertension
- Uncontrolled hyperglycemia
- Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- History or current interstitial lung disease or noninfectious pneumonia needing systemic glucocorticoids
- Active or history of inflammatory bowel disease
- History of immune deficiency, HIV positive, or long-term use of systemic corticosteroids or immunosuppressants
- Known history of allogeneic organ or hematopoietic stem cell transplantation
- Untreated active hepatitis B or active hepatitis C
- Unresolved toxicity from previous antitumor therapy above grade 1 (except alopecia and fatigue)
- Known allergy or severe hypersensitivity to study drug components or other monoclonal antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
X
Xiao Xu, MD, PhD
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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