Could a simple fruit acid boost cancer treatment?
NCT ID NCT07325123
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether adding malic acid (a natural fruit acid) to standard immunotherapy is safe for people with solid tumors like colorectal, lung, or melanoma cancer. About 30 participants will take malic acid by mouth while continuing their immunotherapy. The main goal is to check safety and find the right dose, while also looking at basic health markers like blood counts, weight, and appetite.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Dec 2025
An estimate. Start dates often move.
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to why some cancer treatments work better
- Can an Anti-Fibrotic drug shield lungs from radiation after immunotherapy?
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- App aims to catch a hidden radiotherapy side effect
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers