Advanced Solid Tumors, Non Small Cell Lung Cancer, Small Cell Lung Cancer
Conditions
Keywords
Advanced solid tumors, PD1/VEGF Bispecific, Antibody drug conjugate, Non Small Cell Lung Cancer, Small Cell Lung Cancer
Brief summary
This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.
Interventions
DRUGYL201
YL201 will be administered as IV infusion
DRUGIvonescimab
Ivonescimab will be administered as IV infusion.
Sponsors
Akesobio
MediLink Therapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old. 2. Inclusion criteria for the study population： Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC. 3. ECOG PS score is 0 or 1. 4. Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements.
Exclusion criteria
1. Suitable for local curative treatment. 2. Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs). 3. Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors. 4. Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) \[anti-PD-(L)1\] or other immune checkpoint inhibitors. 5. History of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks before randomization. 6. Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels. 7. Active autoimmune disease requiring systemic treatment. 8. Brain metastases or spinal cord compression. 9. Patients with uncontrolled or clinically significant cardiovascular diseases. 10. Clinically significant concurrent pulmonary diseases. 11. Known to have active pulmonary tuberculosis. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Approximately within 36 months | AEs are assessed based on NCI CTCAE v5.0. |
| Maximum tolerate dose（MTD) | Approximately within 36 months | — |
| Recommended Dose for Expansion | Approximately within 36 months | — |
| Objective Response Rate (ORR) | Approximately within 36 months | ORR defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma clearance (CL) | Approximately within 36 months | — |
| half-life (t1/2) | Approximately within 36 months | — |
| Time to peak drug concentration (Tmax) | Approximately within 36 months | — |
| Investigator-assessed progression-free survival (PFS) | Approximately within 36 months | PFS defined as the time interval from the first study drug administration to the first documented PD or death due to any cause, whichever occurs first |
| Area Under the Concentration-time Curve (AUC) | Approximately within 36 months | — |
| Investigator-assessed disease control rate (DCR) | Approximately within 36 months | DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD). |
| Investigator-assessed time to response (TTR) | Approximately within 36 months | TTR defined as the time interval from the first study drug administration to the first documentation of response (CR or PR). |
| Investigator-assessed the depth of response (DpR) per RECIST v1.1 | Approximately within 36 months | The percentage change in target lesion size |
| number of subjects who are Anti-Drug Antibody (ADA)-positive at any time | Approximately within 36 months | — |
| Investigator-assessed overall survival (OS) | Approximately within 36 months | OS defined as the time interval from the first study drug administration to death due to any cause. |
| maximum concentration (Cmax) | Approximately within 36 months | — |
| minimum concentration at trough (Ctrough) | Approximately within 36 months | — |
| Volume of distribution (Vd) | Approximately within 36 months | — |
Countries
China
Contacts
Primary ContactMediLink Threrapeutics
Outcome results
None listed