Neoplams
Conditions
Keywords
advanced solid tumors, ADC
Brief summary
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors. The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
Interventions
BIOLOGICALMST-168
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
Sponsors
Mabsoft Therapeutics (Shanghai) Co., Ltd.
Mabsoft Therapeutics (Australia) Pty. Ltd.
Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants are eligible to be included in the study only if all of the following criteria apply: I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol. I2. Is at least 18 years of age at the time of signing the ICF. I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. I4. Life expectancy ≥ 12 weeks. I5. Has adequate organ function. I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168. I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Exclusion criteria
* Participants are excluded from the study if any of the following criteria apply: E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed \[e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases\]. Participants with previously unstable brain or CNS metastases. E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease. E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant. E4. Has known sensitivity to study intervention components or excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLT) | Day 1 - Day 28 |
| Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA. | Through study completion, up to 25 months |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters for MST-168, total anti-drug antibody and free payload: Tmax | Day 1 to Day 8 |
| PK parameters for MST-168, total anti-drug antibody and free payload: Cmax | Day 1 to Day 8 |
| PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t | Day 1 to Day 8 |
| PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞ | Day 1 to Day 8 |
| PK parameters for MST-168, total anti-drug antibody and free payload: t1/2 | Day 1 to Day 8 |
| PK parameters for MST-168, total anti-drug antibody and free payload: CL | Day 1 to Day 8 |
| PK parameters for MST-168, total anti-drug antibody and free payload: Vss | Through study completion, up to 24 months |
| PK parameters for MST-168, total anti-drug antibody and free payload: AUCss | Through study completion, up to 24 months |
| PK parameters for MST-168, total anti-drug antibody and free payload: Css,max | Through study completion, up to 24 months |
| PK parameters for MST-168, total anti-drug antibody and free payload: Css,min | Through study completion, up to 24 months |
| Frequencies of ADAs and neutralizing antibodies specific to MST-168. | Through study completion, up to 24 months |
| Biomarkers: cytokines/chemokines and immune cell phenotypes | Through study completion, up to 24 months |
| Objective response rate (ORR) based on RECIST v1.1. | Through study completion, up to 24 months |
| Duration of response (DoR) based on RECIST v1.1. | Through study completion, up to 24 months |
| Progression-free survival (PFS) based on RECIST v1.1. | Through study completion, up to 24 months |
| Disease control rate (DCR) based on RECIST v1.1. | Through study completion, up to 24 months |
Contacts
CONTACTChanglong Liu
Outcome results
None listed