Solid Tumor
Conditions
Brief summary
This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.
Detailed description
This study is a study of Max-40279-01 in combination with toripalimab in patients with advanced solid tumors. This study includes two Parts, the Part 1 will assess the safety and efficacy of the preset several dose levels of Max-40279-01 and toripalimab, and recommend a dose level of Max-40279-01 combined toripalimab for stage 2. The part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.
Interventions
DRUGMAX-40279-01 and Toripalimab
MAX-40279-01combined with Toripalimab
Sponsors
Maxinovel Pty., Ltd.
Study design
Allocation
NON_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. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or metastatic solid tumor. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>3 months. 5. Signed informed consent form.
Exclusion criteria
1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLTs | 21 days | Dose limiting toxicity |
| Incidence of Treatment-Emergent Adverse Events | 24 months | Safety and tolerability assessed by incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1/2 | Approximately 6 months | Half-life of Max-40279 |
| The blood concentration of toripalimab | Approximately 6 months | The blood concentration of toripalimab |
| ADA | 6 months | Anti-drug antibody of toripalimab |
| Tmax | Approximately 6 months | Time to maximum plasma concentration of Max-40279 |
| Subsequent clinical recommended dose | 12 months | Subsequent clinical recommended dose |
| The efficacy end points: ORR、DCR，PFS，DOR，OS | 24 months | Objective response rate,Disease control rate,Progression-free survival,Duration of response,Overall survival |
| the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors | 24 months | the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors |
| Cmax | Approximately 6 months | Maximum plasma drug concentration of Max-40279 |
| AUC | Approximately 6 months | Area under the time-concentration curve of Max-40279 |
Countries
China
Contacts
Primary ContactHanying MD Bao, Ph.D
Outcome results
None listed