CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. The primary endpoint is progression-free survival.

Official Title
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The Efficacy and Safety of CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma: a Randomized, Double-blind, Double Dummy, Multicenter Study

Conditions
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Renal Cell Cancer Metastatic

Intervention / Treatment
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* Drug: CM082 combined with everolimus
* Drug: CM082
* Drug: Everolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma Progressed on at least one standard therapy with VEGFR TKI Measurable disease per Recist v1.1 Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1 Life expectancy of at least 12 weeks Adequate organ functions, and meet the following requirements: Bone marrow: ANC ≥1.5*109/L (1500/mm3), platelet ≥100*109/L, and hemoglobin ≥9 g/dL Liver: Total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤5x the upper limit of normal with liver involvement Kidney: Creatinine ≤ 1.25 x ULN, urine protein <1+ Heart: LVEF ≥ 50% Willingness and ability to comply with trial and follow-up procedures Ability to understand the nature of this trial and give written informed consent Exclusion Criteria: Currently receiving anti-cancer treatment; currently or previously have received 2 or more systemic anti-cancer treatment Other tumors in addition to renal cell carcinoma Females who are pregnant or breastfeeding Known hypersensitivities to CM082 or everolimus Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol Patients with known central nervous system (CNS) metastases Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 or everolimus Any active infection Drug or alcohol abuser

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM082 combined with everolimus<br> | Drug: CM082 combined with everolimus<br>* CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles<br>* Other names: Affinitor;|
| Experimental: CM082<br> | Drug: CM082<br>* CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for everolimus (2 tablets) taken orally once a day on 28-day cycles<br>* Other names: X-82;|
| Active Comparator: Everolimus<br> | Drug: Everolimus<br>* Everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for CM082 (2 tablets) taken orally once a day on 28-day cycles<br>* Other names: Affinitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The internal between the date of randomization and the date of death | 36 months | 
| Objective response rate | The percentage of patients with tumor response in overall population | 8 weeks |