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Trial Title:
A Phase Ib/II Clinical Study of AK127 in Combination With AK112 in Patients With Advanced Solid Tumors
NCT ID:
NCT05951608
Condition:
Advanced Solid Tumors
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK127 in combination with AK112
Description:
AK127 in combination with AK112 (administered on Day 1 of each cycle, Q3W) up to 2 years
Arm group label:
AK127 in combination with AK112
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
Detailed description:
The study consisted of two parts. The first part, Phase Ib is to characterize the safety,
tolerability, pharmacokinetics (PK), immunogenicity of AK127 in combination with AK112 in
adult subjects with advanced solid tumor malignancies. The part, as a dose escalation
phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose
(RP2D) for AK127 in combination with AK112, and describe Dose Limiting Toxicity (DLT).The
second part, Phase II is to Evaluate the anti-tumor activity of AK127 in combination with
AK112 in different tumor species cohorts.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05951608
