AK127 in combination with AK112: AK127 in combination with AK112 (administered on Day 1 of each cycle, Q3W) up to 2 years
Study summary
A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in combination with AK112 in Patients with Advanced Malignant Tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
4. Life expectancy ≥3 months;
5. Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
6. Adequate organ function.
7. Patients of childbearing potential must agree to use effective contraceptive measures.
Exclusion Criteria:
1. The patient has received prior immunotherapy against TIGIT target.
2. The patient had previously been treated with anti-PD -(L)1 and anti-VEGF targets.
3. Currently enrolled in any other clinical study.
4. Receipt of any anticancer therapy within 4 weeks prior to the first dose of Investigational drug;
5. Symptomatic central nervous system metastases.
6. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
7. Active autoimmune disease requiring systemic treatment prior to the start of study treatment.
8. There is a history of major diseases 1 year prior to the first dose.
9. Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
10. Received chest radiation therapy prior to the first dose
11. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
12. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
13. Receipt of live or attenuated vaccination within 4 weeks prior to the first dose of Investigational drug.
14. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
15. Known history of active tuberculosis.
16. History of organ transplant or hematopoietic stem cell.
17. History of primary immunodeficiency.
18. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
19. Other cases deemed inappropriate by the investigator.
Primary outcome measure(s)
Number of participants with adverse events (AEs) — From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Number of participants with a Dose Limiting Toxicity (DLT) — During the first 3 weeks DLTs will be assessed during the first 3 weeks of treatment for dose-escalation Ib phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (3 weeks) of treatment
Number of participants with ORR — Up to 2 years Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by investigator based on RECIST v1.1
Progression-Free Survival — Up to 2 years PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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