Clinical trial · Interventional
Study of the Combination of CM082 With Everolimus in Patients With mRCC
Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy
NCT02577458CI-TRIAL-00031116unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Advanced Renal Cell Carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM082 | Drug | — | UNRESOLVED |
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CM082 plus everolimus
- description
- CM082 plus everolimus
- interventionNames
- Drug: CM082
- Drug: Everolimus
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 12 months
- description
- To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients
Secondary outcomes (3)
- measure
- Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma * Progressed on at least one standard therapy * Measurable disease per Recist1.1 * Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1 * Life expectancy of at least 12 weeks * No abnormal bone marrow function * Adequate heart, lung, liver, kidney organ system functions, and meet the following requirements: * 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. * Creatinine ≤ 1.5 x ULN * Urine protein \<1+ * QTcF \< 450 ms * LVEF ≥ 50% * At least 4 weeks after receiving cancer therapy (i.e., chemotherapy, radiation therapy, biologic therapy, hormonal therapy); 3 months after surgery and recovered * 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 * Other tumors in addition to renal cell carcinoma * Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks * Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes * Patients with a history of intolerance to, or significant toxicity with VEGFR tyrosine kinase inhibitor(s) (TKI) or everolimus * Females who are pregnant or breastfeeding * Those in reproductive ages who refuse to use contraception * 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 * Patients with known severe lung disorders such as asthma, chronic obstructive pulmonary disease (COPD) * Patients who are HIV positive * Drug or alcohol abuser
References
Publications (0)
Data not yet available
No reference posted for this study.