Solid Tumor
Conditions
Keywords
NSCLC, SCLC
Brief summary
This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.
Detailed description
A Multi-center, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 with or without Chemotheray in Patients With Advanced Solid Tumors.
Interventions
DRUG7MW3711
7MW3711 will be administered as IV infusion.
DRUGJS207
JS207 will be administered as IV infusion.
DRUGCisplatin
Cisplatin will be administered as IV infusion.
DRUGCarboplatin
Carboplatin will be administered as IV infusion.
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 2. Life expectancy of at least 3 months as assessed by the Investigator. 3. Phase 1b: Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies. Phase 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors. 4. Measurable or evaluable disease by RECIST v1.1. 5. Have adequate hematopoietic, renal and hepatic functions. 6. Men or women willing to use adequate contraceptive measures throughout the study.
Exclusion criteria
1. Have other prior malignancies within 3 years before the first administration. 2. Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases. 3. Have significant, uncontrolled, or active cardiovascular disease. 4. Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration. 5. Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V6.0. 6. Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV. 7. Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor. 8. Prior treatment with B7-H3 targeted agents. 9. Have received any other investigational drugs or medical device within 4 weeks prior to the first administration. 10. Pregnant, or nursing females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Expansion Dose (RED) | Up to approximately 2 years | RED of 7MW3711 |
| Incidence and severity of adverse events (AEs) | Up to approximately 2 years | AEs are assessed based on NCI CTCAE v6.0. |
| Maximum tolerate dose（MTD) | Up to approximately 2 years | MTD of 7MW3711 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Half-life (t1/2) | Up to approximately 2 years | t1/2 of 7MW3711 |
| Time to peak drug concentration (Tmax) | Up to approximately 2 years | Tmax of 7MW3711 |
| Investigator-assessed progression-free survival (PFS) | Up to approximately 2 years | 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) | Up to approximately 2 years | AUC of 7MW3711 |
| Investigator-assessed disease control rate (DCR) | Up to approximately 2 years | DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD). |
| Immunogenicity | Up to approximately 2 years | Incidence and rates of ADA |
| Overall survival (OS) | Up to approximately 2 years | OS defined as the time interval from the first study drug administration to death due to any cause. |
| Maximum concentration (Cmax) | Up to approximately 2 years | Cmax of 7MW3711 |
| Plasma clearance (CL) | Up to approximately 2 years | CL of 7MW3711 |
Countries
China
Contacts
CONTACTShun Lu, Doctor
Outcome results
None listed