A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors
- Conditions
- Solid Tumor
- Interventions
- Drug: "MAX-40279-01" and "Toripalimab"
- Registration Number
- NCT05369286
- Lead Sponsor
- Maxinovel Pty., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 28
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic solid tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >3 months.
- Signed informed consent form.
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0) at the time of randomization.
- Inadequate organ or bone marrow function.
- Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dose level 1 of max-40279 combined dose level 1 of toripalimab "MAX-40279-01" and "Toripalimab" "MAX-40279-01" and "toripalimab" dose level 2 of max-40279 combined dose level 1 of toripalimab "MAX-40279-01" and "Toripalimab" "MAX-40279-01" and "toripalimab" dose level 2 of max-40279 combined dose level 2 of toripalimab "MAX-40279-01" and "Toripalimab" "MAX-40279-01" and "toripalimab" dose level 3 of max-40279 combined dose level 2 of toripalimab "MAX-40279-01" and "Toripalimab" "MAX-40279-01" and "toripalimab" recommend dose of max-40279 combined recommend dose level of toripalimab "MAX-40279-01" and "Toripalimab" "MAX-40279-01" and "toripalimab"
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Subsequent clinical recommended dose 12 months Subsequent clinical recommended dose
Cmax Approximately 6 months Maximum plasma drug concentration of Max-40279
Tmax Approximately 6 months Time to maximum plasma concentration of Max-40279
AUC Approximately 6 months Area under the time-concentration curve of Max-40279
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
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
Trial Locations
- Locations (1)
Institute of The Sixth Affiliated Hospital Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China