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This is a study on the safety and efficacy of malic acid supplementation combined with immunotherapy for anti-tumor treatment in patients with solid tumors. The primary study objective is to determine the oral safety of malic acid; Secondary study objectives: 1. To evaluate the preliminary efficacy of malic acid in the study population. 2. To determine the recommended phase 2 dose (RP2D) of oral malic acid. Exploratory endpoints: Immune indicators including white blood cell count, neutrophil, lymphocyte, monocyte, eosinophil and basophil (count/proportion); metabolic indicators including blood glucose, triglycerides; nutritional indicators including body weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malic Acid | Drug | This is a study on the safety and efficacy of malic acid supplementation combined with immunotherapy for anti-tumor treatment in patients with solid tumors. Primary study objective: To determine the oral safety of malic acid. Secondary study objectives: 1. To evaluate the preliminary efficacy of malic acid in the study population. 2. To determine the recommended phase 2 dose (RP2D) of oral malic acid. Exploratory endpoints: Immune indicators including white blood cell count, neutrophil, lymphocyte, monocyte, eosinophil and basophil (count/proportion); metabolic indicators including blood glucose, triglycerides; nutritional indicators including body weight. Starting dose: The proposed starting dose of malic acid (MA) in humans is 30 mg/kg/day (for two immunotherapy cycles). Dose levels: 30 mg/kg/day → 60 mg/kg/day → 90 mg/kg/day (with an incremental increase not exceeding 100%), to be administered after meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events (AE); Recommended Phase 1 Clinical Dose | At the begin of Cycle 1(each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | At the end of Cycle 1(each cycle is 21 days) | |
| Patient - reported outcome (PRO) | At the begin of Cycle 1(each cycle is 21 days) | |
| Measure | Description | Time Frame |
|---|---|---|
| White Blood Cell Count | At the begin and end of Cycle 1(each cycle is 21 days) | |
| Neutrophil Count and Proportion | At the begin and end of Cycle 1(each cycle is 21 days) | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yinghua Ji | Contact | China: +86 13663030446 | 54234317@qq.com |
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| ID | Term |
|---|---|
| C030298 | malic acid |
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|
| Nutritional scale score |
Appetite, body weight, muscle strength, vitality, serum protein levels (related to liver function), etc. |
| baseline period |
| Lymphocyte Count and Proportion |
| At the begin and end of Cycle 1(each cycle is 21 days) |
| Monocyte Count and Proportion | At the begin and end of Cycle 1(each cycle is 21 days) |
| Eosinophil Count and Proportion | At the begin and end of Cycle 1(each cycle is 21 days) |
| Basophil Count and Proportion | At the begin and end of Cycle 1(each cycle is 21 days) |
| Blood Glucose | At the begin and end of Cycle 1(each cycle is 21 days) |
| Triglycerides | At the begin and end of Cycle 1(each cycle is 21 days) |
| Safety Endpoints: Including adverse events (AEs), serious adverse events (SAEs), laboratory test abnormalities, electrocardiogram (ECG) abnormalities, and others. | On the 1st day of each 21-day treatment cycle. |