A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.

Detailed Description
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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.

Official Title
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A Phase 1 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Combination With Toripalimab in Patients With Advanced Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: MAX-40279-01 and Toripalimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose level 1 of max-40279 combined dose level 1 of toripalimab<br>MAX-40279-01 and toripalimab | Drug: MAX-40279-01 and Toripalimab<br>* MAX-40279-01combined with Toripalimab<br>|
| Experimental: dose level 2 of max-40279 combined dose level 1 of toripalimab<br>MAX-40279-01 and toripalimab | Drug: MAX-40279-01 and Toripalimab<br>* MAX-40279-01combined with Toripalimab<br>|
| Experimental: dose level 2 of max-40279 combined dose level 2 of toripalimab<br>MAX-40279-01 and toripalimab | Drug: MAX-40279-01 and Toripalimab<br>* MAX-40279-01combined with Toripalimab<br>|
| Experimental: dose level 3 of max-40279 combined dose level 2 of toripalimab<br>MAX-40279-01 and toripalimab | Drug: MAX-40279-01 and Toripalimab<br>* MAX-40279-01combined with Toripalimab<br>|
| Experimental: recommend dose of max-40279 combined recommend dose level of toripalimab<br>MAX-40279-01 and toripalimab | Drug: MAX-40279-01 and Toripalimab<br>* MAX-40279-01combined with Toripalimab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLTs | Dose limiting toxicity | 21 days | 
| Incidence of Treatment-Emergent Adverse Events | Safety and tolerability assessed by incidence and severity of adverse events | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent clinical recommended dose | Subsequent clinical recommended dose | 12 months | 
| Cmax | Maximum plasma drug concentration of Max-40279 | Approximately 6 months | 
| Tmax | Time to maximum plasma concentration of Max-40279 | Approximately 6 months | 
| AUC | Area under the time-concentration curve of Max-40279 | Approximately 6 months | 
| T1/2 | Half-life of Max-40279 | Approximately 6 months | 
| The blood concentration of toripalimab | The blood concentration of toripalimab | Approximately 6 months | 
| ADA | Anti-drug antibody of toripalimab | 6 months | 
| The efficacy end points: ORR、DCR，PFS，DOR，OS | Objective response rate,Disease control rate,Progression-free survival,Duration of response,Overall survival | 24 months | 
| the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors | the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors | 24 months |