Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer
Brief summary
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.
Detailed description
This is a multicenter, open-label phase Ib/II study of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. The phase Ib portion is designed to evaluate the safety, tolerability, and preliminary antitumor activity of AK138D1 in combination with ivonescimab. The phase II portion is designed to evaluate the safety and efficacy of AK138D1 as monotherapy or in combination with ivonescimab.
Interventions
DRUGAK138D1
Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
DRUGIvonescimab
Enrolled subjects will receive intravenous infusion (IV) of Ivonescimab according to the dosing regimen specified in their cohort.
DRUGCarboplatin
Enrolled subjects will receive intravenous infusion (IV) of Carboplatin according to the dosing regimen specified in their cohort.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The subject must sign the written informed consent form (ICF) voluntarily; 2. At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible; 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4. Has a life expectancy of ≥ 3 months; 5. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 6. Has Stage IIIB/IIIC or IV NSCLC (American Joint Committee on Cancer \[AJCC\]). 7. Adequate organ function.
Exclusion criteria
1. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study; 2. Presence of active central nervous system (CNS) metastases. 3. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed; 4. Untreated subjects with active hepatitis B or active hepatitis C; 5. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease; 6. Known active syphilis infection; 7. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies; 8. Other reasons for ineligibility as evaluated by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | Up to approximately 2 years | Incidence and severity of subjects with adverse events |
| Objective Response Rate (ORR) | Up to approximately 2 years | Objective Response Rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR) , assessed by investigator according to RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Up to approximately 2 years | Disease control rate (DCR) assessed by investigator according to RECIST v1.1. |
| Duration of response (DoR) | Up to approximately 2 years | Duration of response (DoR) assessed by investigator according to RECIST v1.1. |
| Time to response (TTR) | Up to approximately 2 years | Time to response (TTR) is defined as the time to response assessed by investigator according to RECIST v1.1. |
| Progression Free Survival (PFS) | Up to approximately 2 years | PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1) assessed by investigator or death due to any cause, whichever occurs first. |
| Overall Survival (OS) | Up to approximately 2 years | Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
| Pharmacokinetics (PK) characteristics | Up to approximately 2 years | Serum drug concentration profiles at different time points after administration. |
| Anti-drug antibodies (ADA) | Up to approximately 2 years | Number of subjects with detectable anti-drug antibodies (ADA). |
Countries
China
Contacts
CONTACTXufang Yu
Outcome results
None listed