Solid Tumor MalignanciesEarly Phase 1NCT07325123
Malic Acid Supplementation Combined With Immunotherapy in Patients With Solid Tumors
A Early Phase 1 study testing Malic Acid in people with Solid Tumor Malignancies, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- Malic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years (inclusive), male or female;
- Patients with malignant solid tumors such as colorectal cancer, lung cancer, and melanoma, confirmed by histopathological or cytological examination;
- Patients have at least one measurable lesion;
- Undergoing systematic anti-tumor treatment with immunotherapy;
- Expected survival time ≥ 3 months;
- Basic functions of major organs are norma，laboratory tests meet the following criteria：Hematology (No blood transfusion or blood products administered, and no use of G-CSF or other hematopoietic stimulants for correction within 7 days prior to laboratory testing): Absolute neutrophil count ≥ 1.5×10⁹/L; Platelets ≥ 75×10⁹/L; Hemoglobin ≥ 90g/L. Kidney: Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) > 60ml/min/1.73m² (Cockcroft-Gault formula). Liver: Serum total bilirubin < 1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5×ULN or ≤ 5×ULN (for subjects with liver metastases); Albumin (ALB) ≥ 30g/L. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) < 1.5×ULN. For subjects receiving anticoagulant therapy, it is acceptable as long as PT is within the intended range for the anticoagulant used.l;
- For female subjects of childbearing age during the screening period, the serum pregnancy test result must be negative; female/male subjects of reproductive potential must be willing to use reliable contraceptive methods throughout the entire study period (i.e., from signing the informed consent form to 90 days after the last administration of the study drug), including but not limited to: abstinence, vasectomy of the male partner, female sterilization, effective intrauterine devices (IUDs), and effective contraceptive medications.
- Patients voluntarily participate in this study, sign the informed consent form, and have good compliance.
Who cannot join
- Subjects who have not recovered from adverse events caused by any intervention to ≤ Grade 1 (except for alopecia, hearing impairment, and Grade ≤ 2 neurological or endocrine disorders requiring replacement therapy) prior to the first dose;
- Subjects who have undergone major or moderate surgery (other than for diagnosis or biopsy) within 28 days prior to the first dose, or are expected to undergo major surgery during the study;
- Subjects with severe chronic obstructive pulmonary disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease [GOLD] ≥ Grade 3), or who have had intestinal adhesions or intestinal obstruction within 6 months prior to the first dose;
- Subjects with severe cardiovascular diseases, such as New York Heart Association (NYHA) Heart Disease (Class III or higher), myocardial infarction within 6 months, current unstable angina, or uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg);
- Subjects with uncontrolled primary brain tumors or central nervous system (CNS) metastases, with significant intracranial hypertension or neuropsychiatric symptoms;
- Subjects with uncontrollable neuropsychiatric diseases, mental disorders, or substance abuse, which may affect trial compliance;
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- Subjects with active infections requiring systemic treatment;
- Subjects with a known history of human immunodeficiency virus (HIV) infection;
- Subjects with hepatitis B virus (HBV) infection (HBsAg-positive or HBcAb-positive, with HBV-DNA ≥ 2000 IU/mL or HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C virus (HCV) infection (HCV antibody-positive, with HCV-RNA quantitative test result above the lower limit of detection); Note: For subjects with HBV infection and HBV-DNA < 2000 IU/mL or HBV-DNA < 10⁴ copies/mL, those who are willing to receive antiviral therapy (such as entecavir, tenofovir, or other antiviral drugs) based on clinical judgment during the study may be enrolled;
- Subjects with medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results, prevent the subject from completing the entire study, or are deemed by the investigator as not being in the subject's best interest to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study on the Safety and Efficacy of Malic Acid Supplementation Combined With Immunotherapy in Patients With Solid Tumors
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.
- Conditions
- Solid Tumor Malignancies
- Being tested
- Malic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malic AcidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| dose group | Experimental | Not described Receives: Drug: Malic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse Events (AE); Recommended Phase 1 Clinical Dose
Measured: At the begin of Cycle 1(each cycle is 21 days)
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: At the end of Cycle 1(each cycle is 21 days)
Patient - reported outcome (PRO)
Measured: At the begin of Cycle 1(each cycle is 21 days)
Nutritional scale score
Appetite, body weight, muscle strength, vitality, serum protein levels (related to liver function), etc.
Measured: baseline period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325123
- Sponsor's protocol ID
- Chase019
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Safety and Efficacy of Malic Acid Supplementation Combined With Immunotherapy in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07325123
- Acronym / sponsor ID
- Chase019
- Conditions
- Solid Tumor Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose group | Experimental | Drug: Malic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years (inclusive), male or female;
- Patients with malignant solid tumors such as colorectal cancer, lung cancer, and melanoma, confirmed by histopathological or cytological examination;
- Patients have at least one measurable lesion;
- Undergoing systematic anti-tumor treatment with immunotherapy;
- Expected survival time ≥ 3 months;
Key exclusion criteria (10 listed)
- Subjects who have not recovered from adverse events caused by any intervention to ≤ Grade 1 (except for alopecia, hearing impairment, and Grade ≤ 2 neurological or endocrine disorders requiring replacement therapy) prior to the first dose;
- Subjects who have undergone major or moderate surgery (other than for diagnosis or biopsy) within 28 days prior to the first dose, or are expected to undergo major surgery during the study;
- Subjects with severe chronic obstructive pulmonary disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease [GOLD] ≥ Grade 3), or who have had intestinal adhesions or intestinal obstruction within 6 months prior to the first dose;
- Subjects with severe cardiovascular diseases, such as New York Heart Association (NYHA) Heart Disease (Class III or higher), myocardial infarction within 6 months, current unstable angina, or uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg);
- Subjects with uncontrolled primary brain tumors or central nervous system (CNS) metastases, with significant intracranial hypertension or neuropsychiatric symptoms;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malic AcidThis 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. | Drug | dose group |
Primary outcome
Safety: Adverse Events (AE); Recommended Phase 1 Clinical Dose
Time frame: At the begin of Cycle 1(each cycle is 21 days)
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: At the end of Cycle 1(each cycle is 21 days)
Patient - reported outcome (PRO)
Time frame: At the begin of Cycle 1(each cycle is 21 days)
Nutritional scale score
Time frame: baseline period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Malic Acid in people with Solid Tumor Malignancies, run by The First Affiliated Hospital of Xinxiang Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinghua Ji (China: +86 13663030446, 54234317@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse Events (AE); Recommended Phase 1 Clinical Dose (time frame: At the begin of Cycle 1(each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.