Solid Tumors
Conditions
Brief summary
This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.
Interventions
DRUG9MW2821
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
DRUGOther anti-cancer therapy
Subjects will receive other anticancer therapy as per protocol
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form. 2. Male or female subjects aged 18 to 75 years (including 18 and 75 years). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors. 5. Adequate tumor tissues submitted for test. 6. Life expectancy of ≥ 12 weeks. 7. Subjects must have measurable disease according to RECIST (version 1.1). 8. Adequate organ functions. 9. Sexually active fertile subjects, and their partners, must agree to use contraception during the study and at least 6 months after termination of study therapy. 10. Subjects are willing to follow study procedures.
Exclusion criteria
1. History of another malignancy within 3 years before the first dose of study drug. 2. Ongoing clinically significant toxicities related to prior treatment. 3. Grade ≥ 2 peripheral neuropathy. 4. Severe or uncontrolled gastrointestinal diseases. 5. Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance. 6. Experienced clinically significant bleeding or had a clear bleeding tendency. 7. Central nervous system (CNS) metastasis and/or malignant meningitis. 8. Clinically significant pleural, abdominal, or pericardial effusion. 9. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug; 10. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness. 11. Pregnant and lactating women. 12. Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AE/SAE (phase Ib) | Up to approximately 24 months | Adverse event (AE), serious adverse event (SAE) |
| Objective Response Rate, ORR (phase II) | Up to approximately 24 months | The proportion of participants with complete response (CR) or partial response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate, DCR | Up to approximately 24 months | The percentage of subjects who experience CR, PR or stable disease (SD) |
| Progression-Free Survival, PFS | Up to approximately 24 months | Time from the date of first infusion to the earliest date of disease progression or death |
| Overall Survival, OS | Up to approximately 24 months | Time from the date of first infusion to the date of death |
| Pharmacokinetics parameter, Tmax | Up to approximately 24 months | Peak time |
| Pharmacokinetics parameter, Cmax | Up to approximately 24 months | Maximum concentration |
| Duration of Response, DOR | Up to approximately 24 months | Time from the date of the first CR or PR to the earliest date of disease progression or death |
| Pharmacokinetics parameter, t1/2 | Up to approximately 24 months | Half-life |
| Pharmacokinetics parameter, V | Up to approximately 24 months | Apparent volume of distribution |
| Pharmacokinetics parameter, CL | Up to approximately 24 months | Clearance |
| Immunogenicity parameter | Up to approximately 24 months | Anti-Drug Antibody (ADA) of 9MW2821 |
| Pharmacokinetics parameter, AUC | Up to approximately 24 months | Area under the concentration-time curve |
| Time To Response, TTR | Up to approximately 24 months | Time from the date of first infusion to the date of CR or PR |
Countries
China
Contacts
Primary ContactFeng Wang
Outcome results
None listed