Cisplatin NephrotoxicityPhase 1NCT07824843

Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction

A Phase 1 study testing GMDTC 1 mg/ml, GMDTC 2mg/ml and GMDTC 3mg/ml in people with Cisplatin Nephrotoxicity and Cisplatin Adverse Reaction, run by Guangdong Jianersheng Pharmaceutical Technology Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This trial is a multicenter, combined hydration, multiple-dose, dose-escalation phase Ib clinical study, designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of the injection product GMDTC in participants with solid tumors and cisplatin-induced mild renal impairment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
What is being tested?: GMDTC 1 mg/ml, GMDTC 2mg/ml and GMDTC 3mg/ml
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: Oct 2026to Dec 2027
Phase: 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

The subject is able to understand and voluntarily sign a written Informed Consent Form (ICF), agreeing to comply with the study protocol.
When signing the ICF, the participant must be at least 18 years of age, regardless of gender.
The expected survival period of the subjects is ≥ 6 months.
The subjects have an ECOG performance status score of 0 or 1.
Malignant solid tumors (excluding renal cell carcinoma) diagnosed by histological or cytological examination must simultaneously meet the following criteria:
Participants who have previously received cisplatin-based chemotherapy and developed mild cisplatin-induced renal insufficiency, and who are still scheduled to undergo cisplatin-based chemotherapy; Mild renal insufficiency is defined as: during the screening phase, estimated glomerular filtration rate (eGFR) ≥ 60 and < 90 mL/min/1.73 m² (calculated using the CKD-EPI formula).

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Within 7 days prior to the first administration, participants shall be assessed for adequate bone marrow function, as well as normal cardiac, pulmonary, hepatic, and coagulation function, based on the following laboratory tests (transfusion or administration of other growth factor-based supportive therapy is prohibited within 14 days prior to the first dose of the investigational product):
Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 90 g/L; Liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or total bilirubin (TBIL) ≤ 3 × ULN (in cases of Gilbert syndrome); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN (≤ 5 × ULN if hepatic metastases are present); Serum albumin (ALB) ≥ 30 g/L; Coagulation function (in patients not receiving anticoagulant therapy): Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.5 × ULN. Patients receiving long-term anticoagulant therapy may participate in the study provided they have been on a stable anticoagulant dose for at least one month prior to the first administration of the investigational product. Unless the anticoagulant is a factor Xa inhibitor, a stable dose must be maintained for at least one week.
Women of childbearing potential must agree to take reliable contraceptive measures or abstain from sexual activity from the moment they sign the informed consent form until 6 months after the last administration of the investigational drug. Women of childbearing age must have a negative serum pregnancy test within 7 days before the first dose.
Male participants must agree to take reliable contraceptive measures or abstain from sexual activity from the moment they signed the informed consent form until six months after the last administration of the investigational drug. Additionally, male participants must agree not to donate sperm during this period.

Who cannot join

Those who have participated in any other clinical trials within 4 weeks before the first administration of the investigational drug or within 5 half-lives (whichever is shorter);
Those who are known or suspected to be allergic to any active ingredient or excipient of this product, or who have a specific history of allergic reactions as determined by the investigator to be unsuitable for treatment with the investigational drug;
Those who are known or suspected to be allergic to any active ingredient or excipient of cisplatin or any other platinum-based drugs;
The researchers identified those participants who would require a dose adjustment of cisplatin upon their first administration after being included in the study.
Previous administration and toxicity recovery status:
Before the first administration of the investigational drug, all adverse events (AEs) experienced by the participants during previous anti-tumor administration had not returned to baseline levels or were ≤ grade 1 (based on NCI CTCAE V6.0). Participants with the following conditions are allowed to be included: alopecia (any grade), participants with renal insufficiency (estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73 m2); participants with other AEs (≤ grade 2), and their inclusion is determined by the investigator;

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Those who have taken any drugs or health supplements (such as SGLT2 inhibitors like dapagliflozin, canagliflozin, empagliflozin, englestat, canagliflozin, hexagliflozin, igliflozin, rugliflozin, togliflozin, and natural compounds like aesculin; GLUT2 inhibitors such as cytochalasin B, aesculin, Huoxiang Zhengqi San, luteolin and isofraxidin) that may have interactions with the investigational drug within 4 weeks before the first administration of the investigational drug or 5 half-lives (whichever is longer) are excluded from the study.
Those who have taken any drugs or health supplements (such as colchicine, probenecid, antihistamines, phenothiazine drugs, aminoglycoside antibiotics, amphotericin B, cephalothin, chloramphenicol or its furan benzenic acid or furoxan sodium, penicillamine or other chelating agents) that may have interactions with cisplatin within 4 weeks before the last cisplatin administration or 5 half-lives (whichever is longer) will be excluded from the screening.
Participants with a history of peripheral neuropathy caused by cisplatin.
Participants with chickenpox or shingles, except those who have been cured in the past.
Participants with gout and hyperuricemia.
Participants with a history of type 1 diabetes or type 2 diabetes accompanied by kidney disease.
Patients with severe hepatobiliary disorders, decompensated liver cirrhosis (Child-Pugh class B or C), portal hypertension-related complications (ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy), or any form of cholestatic liver disease.
Patients who have previously undergone liver transplantation or are scheduled for liver transplantation.
Participants with meningeal metastasis.
Uncontrolled CNS metastases are excluded.However, Participants with symptomatic CNS metastases may be eligible if the metastases are limited to the supratentorial and/or cerebellar region (i.e., without metastasis to the midbrain, pons, medulla oblongata, or spinal cord), local treatment has been received, neurological symptoms have been stable for at least 2 weeks before the first dose, and the participant does not require hormone therapy or is receiving ≤ 10 mg/day prednisone (or equivalent).
Within 5 years prior to the first administration of the investigational drug, the subject had other malignant tumors (excluding the solid tumor diseases treated with cisplatin as part of this study, and excluding skin basal cell carcinoma, superficial bladder cancer, in situ cervical cancer, etc., which were considered eligible for inclusion by the investigators and had not recurred within the previous 5 years).
There is a history of previous administration of allogeneic organ transplantation or allogeneic peripheral blood stem cell (PBSC)/immune cell/marrow transplantation.
The subject had undergone major surgical procedures within 4 weeks prior to the first administration of the investigational drug, or had not yet fully recovered from any previous invasive procedures.
Clinically significant cardiovascular diseases include:
Within 6 months prior to the first administration of the investigational drug, there was a myocardial infarction, unstable angina pectoris, viral myocarditis or other uncontrolled heart disease;
Left ventricular ejection fraction (LVEF) < 50%, congestive heart failure with NYHA cardiac function classification of II-IV;
Symptomatic orthostatic hypotension occurred within 6 months prior to the first administration of the investigational drug;
Uncontrolled hypertension [after standard medication, systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg or a history of hypertension crisis or hypertensive encephalopathy];
QTc > 470 ms (female), QTc > 450 ms (male), or a known family history of long QT syndrome;
History of cardiac surgery such as angioplasty or coronary artery bypass grafting within 6 months prior to the first administration of the investigational drug;
Uncontrolled seizures despite appropriate medical treatment.
Within 6 months prior to the first administration of the investigational drug, the subject had experienced cerebral infarction, cerebral hemorrhage or transient ischemic attack.
Those with interstitial pneumonia or interstitial lung disease, or those who have a history of interstitial pneumonia or interstitial lung disease that affects self-care daily activities or is accompanied by life-threatening respiratory disorders; or those with a history of pulmonary fibrosis, persistent pneumonia, pneumonia caused by drugs or radiotherapy, congenital pneumonia, or any evidence of active pneumonia found on chest CT scan. Or those with severe pulmonary diseases, including but not limited to pulmonary embolism that occurred within 3 months before the first administration, severe asthma, chronic obstructive pulmonary disease (COPD), restrictive lung disease, or active pneumonia, or those whose pulmonary function test indicates severe impairment of lung function.
Those with a history of acute or chronic renal disease due to causes other than cisplatin treatment, or with a history of kidney transplantation, or currently undergoing renal replacement therapy (such as dialysis), or having persistent hematuria for unknown reasons, etc.
Clinically uncontrolled serous cavity effusion (including pleural, pericardial, or peritoneal effusion), as determined by the investigator, is defined as requiring a drainage tube or drainage more than once weekly, and shall be excluded.
Participants who have received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug, or who are expected to require such vaccination during the study, are excluded.
According to the researchers' assessment, there is a history or current condition of autoimmune diseases (such as myasthenia gravis or periodic hypokalemia), severe or uncontrolled systemic diseases, active bleeding disorders or active infections;
Participants with active hepatitis B (HBsAg positive and HBV-DNA ≥ 1000 copies/mL or 500 IU/mL or the lower limit of the center's detection), or active hepatitis C (HCV antibody positive and HCV-RNA above the upper limit of the normal value), or positive screening result for human immunodeficiency virus (HIV) antibody, or active syphilis infection, or active tuberculosis infection will be excluded during the screening process.
Female participants who are pregnant or breastfeeding;
Those who have a clear history of neurological or mental disorders, such as dementia, and have poor compliance.
Other serious diseases, or any other circumstances that the researcher deems may increase the risks for the participants or interfere with the test results, and any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Zhang, Doctor of Medicine contact

＋86 020-87343458

zhangli@syscc.org.cn

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, Doctor of Medicine, ＋86 020-87343458, zhangli@syscc.org.cn

Other trials in China

About this study

Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMDTC in Participants With Solid Tumors Who Have Cisplatin-Induced Renal Insufficiency

Read the detailed description

The primary objective of this study is to evaluate the safety and tolerability of GMDTC in a single-dose, dose-escalation study in participants with mild renal impairment who are scheduled to receive cisplatin-based chemotherapy for solid tumors, and to determine the recommended phase II dose (RP2D) for this drug. The secondary objective is to evaluate the pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, and renal function improvement after single-dose multiple administration of GMDTC following cisplatin chemotherapy in this group of participants.

Conditions: Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
Being tested: GMDTC 1 mg/ml, GMDTC 2mg/ml, GMDTC 3mg/ml
Keywords: Cisplatin, GMDTC, Mild renal dysfunction, Solid tumor, Investigational drugs

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GMDTC 1 mg/mlDrug
Cohort 1: Participants will receive high-dose cisplatin chemotherapy (75mg/m2) on D1 each cycle. Subsequently, they received GMDTC at a concentration of 1 mg/ml via intravenous infusion, once daily for 5 days, over 2 cycles, and then underwent a 2-week follow-up after the last administration.
GMDTC 2mg/mlDrug
Cohort 2: Participants will receive high-dose cisplatin chemotherapy (75mg/m2) on D1 each cycle. Subsequently, they received GMDTC at a concentration of 2 mg/ml via intravenous infusion, once daily for 5 days, over 2 cycles, and then underwent a 2-week follow-up after the last administration.
GMDTC 3mg/mlDrug
Cohort 3: Participants will receive high-dose cisplatin chemotherapy (75mg/m2) on D1 each cycle. Subsequently, they received GMDTC at a concentration of 3 mg/ml via intravenous infusion, once daily for 5 days, over 2 cycles, and then underwent a 2-week follow-up after the last administration.

Study groups in NCT07824843
Study group	Role	What they receive
GMDTC Group	Experimental	All participants receive high-dose cisplatin chemotherapy (75mg/m2) on day 1 , followed by GMDTC administration via intravenous drip. The dosage is 0.5 grams per vial, in 1000 mg, 2000 mg, and 3000 mg once a day. The medication is administered once daily on Days 1-5 of each cycle. Among them, GMDTC starts to be administered 2 hours ± 15 minutes after the cisplatin administration on day 1. GMDTC is reconstituted and diluted with 0.9% sodium chloride injection before administration. The total volume of the liquid for the trial drug GMDTC infusion each day is 1000 ml. Receives: Drug: GMDTC 1 mg/ml; Drug: GMDTC 2mg/ml; Drug: GMDTC 3mg/ml

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Adverse events will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, V6.0), which includes spontaneously reported adverse events as well as clinically significant changes in vital signs, physical examination, laboratory tests, electrocardiogram, and other examinations conducted during the trial.
Measured: Up to 90 days
DLT
DLT is defined as any TEAE (including those definitely related, likely related, and possibly related) to GMDTC that occurs during the DLT observation period (the severity of adverse events [Adverse events, AE] is evaluated according to NCI CTCAE V6.0) or any clinically significant abnormal laboratory test results.
Measured: 21 days after the participant completes the first dose in the dose-escalation phase.
RP2D
RP2D is defined as the Recommended Phase 2 dose.
Measured: From first participant enrollment to the completion of the entire study, approximately 1 year.

Secondary outcomes (13)

Pharmacokinetic parameters,Tmax
Peak time, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Cycle 1 Days 1-5
Pharmacokinetic parameters, Cmax
Peak concentrations, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Cycle 1 Days 1-5
Pharmacokinetic parameters, λz
The apparent terminal elimination rate constant, estimated by log-linear regression of the terminal portion of the concentration-time curve, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Cycle 1 Days 1-5
Pharmacokinetic parameters, t1/2
The apparent terminal elimination half-life, calculated according to the following equation:t1/2= Ln(2)/ λz,reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Cycle 1 Days 1-5
Pharmacodynamic parameters, urine platinum
Urine platinum level before and after drug administration (μmol/mol creatinine)
Measured: Baseline (the day before first dose) and Day1 to Day5 of each cycle.
Pharmacodynamic parameters, amount of platinum excreted in urine over 24 hours
24-hour urine platinum excretion before and after drug administration
Measured: Baseline (the day before first dose) and Day1 to Day5 of each cycle.
Renal function indicators： creatinine clearance
creatinine clearance before and after administration.
Measured: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Pharmacodynamic parameters,Urine platinum excretion rate
Cumulative urinary platinum excretion on Days 1 to 5 of each cycle as a percentage of the administered cisplatin dose.
Measured: Baseline (the day before first dose) and Day1 to Day5 of each cycle.
Renal function indicators：serum creatinine
serum creatinine before and after drug administration.
Measured: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：urea nitrogen/urea,
Urea nitrogen/urea before and after drug administration
Measured: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：estimated glomerular filtration rate (eGFR)
estimated glomerular filtration rate (eGFR) before and after drug administration.
Measured: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：cystatin C
Cystatin C before and after drug administration
Measured: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：24-hour urine protein quantification
24-hour urine protein quantification before and after drug administration.
Measured: Baseline (the day before first dose) ,Day 1of each Cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2026Dec 2027

First posted17 Sep 2026
Study startOct 2026 (estimated)
Primary completionOct 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Cisplatin NephrotoxicityStudies 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: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07824843
Sponsor's protocol ID: JES-GMDTC-2-01
Status last verified: Sep 2026
First submitted: 3 Sep 2026
Last updated: 17 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tang X, Zhu J, Zhong Z, Luo M, Li G, Gong Z, Zhang C, Fei F, Ruan X, Zhou J, Liu G, Li G, Olson J, Ren X. Mobilization and removing of cadmium from kidney by GMDTC utilizing renal glucose reabsorption pathway. Toxicol Appl Pharmacol. 2016 Aug 15;305:143-152. doi: 10.1016/j.taap.2016.06.001. Epub 2016 Jun 6.
PubMed 27282297
Pabla N, Dong Z. Cisplatin nephrotoxicity: mechanisms and renoprotective strategies. Kidney Int. 2008 May;73(9):994-1007. doi: 10.1038/sj.ki.5002786. Epub 2008 Feb 13.
PubMed 18272962
Yao X, Panichpisal K, Kurtzman N, Nugent K. Cisplatin nephrotoxicity: a review. Am J Med Sci. 2007 Aug;334(2):115-24. doi: 10.1097/MAJ.0b013e31812dfe1e.
PubMed 17700201
Esteban-Fernandez D, Verdaguer JM, Ramirez-Camacho R, Palacios MA, Gomez-Gomez MM. Accumulation, fractionation, and analysis of platinum in toxicologically affected tissues after cisplatin, oxaliplatin, and carboplatin administration. J Anal Toxicol. 2008 Mar;32(2):140-6. doi: 10.1093/jat/32.2.140.
PubMed 18334097
Astolfi L, Ghiselli S, Guaran V, Chicca M, Simoni E, Olivetto E, Lelli G, Martini A. Correlation of adverse effects of cisplatin administration in patients affected by solid tumours: a retrospective evaluation. Oncol Rep. 2013 Apr;29(4):1285-92. doi: 10.3892/or.2013.2279. Epub 2013 Feb 6.
PubMed 23404427
Kelland L. The resurgence of platinum-based cancer chemotherapy. Nat Rev Cancer. 2007 Aug;7(8):573-84. doi: 10.1038/nrc2167. Epub 2007 Jul 12.
PubMed 17625587
Miller RP, Tadagavadi RK, Ramesh G, Reeves WB. Mechanisms of Cisplatin nephrotoxicity. Toxins (Basel). 2010 Nov;2(11):2490-518. doi: 10.3390/toxins2112490. Epub 2010 Oct 26.
PubMed 22069563
Mandic A, Hansson J, Linder S, Shoshan MC. Cisplatin induces endoplasmic reticulum stress and nucleus-independent apoptotic signaling. J Biol Chem. 2003 Mar 14;278(11):9100-6. doi: 10.1074/jbc.M210284200. Epub 2002 Dec 31.
PubMed 12509415
Ge Y, Zheng N, Chen X, Zhu J, Sun W, Olson JR, Aga DS, Hu W, Tang X, Ren X. GMDTC Chelating Agent Attenuates Cisplatin-Induced Systemic Toxicity without Affecting Antitumor Efficacy. Chem Res Toxicol. 2019 Aug 19;32(8):1572-1582. doi: 10.1021/acs.chemrestox.9b00097. Epub 2019 Jul 9.
PubMed 31240907

Interested in taking part?

Li Zhang, Doctor of Medicine

＋86 020-87343458

zhangli@syscc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Nephrotoxicity
RecruitingPhase 2
Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
Cisplatin Nephrotoxicity, Nephrotoxicity
Not yet recruitingPhase 2/3
Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity
Nephrotoxicity
RecruitingPhase 2
Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity
Solid Tumors, Cisplatin Nephrotoxicity
Not yet recruitingPhase 2/3
Prevention of Cisplatin-induced Nephrotoxicity
Acute Kidney Injury, Renal Tubulopathy

All Cisplatin Nephrotoxicity trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GMDTC in Participants With Solid Tumors Who Have Cisplatin-Induced Renal Insufficiency
ClinicalTrials.gov ID: NCT07824843
Acronym / sponsor ID: JES-GMDTC-2-01
Conditions: Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
Keywords: Cisplatin, GMDTC, Mild renal dysfunction, Solid tumor, Investigational drugs
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.University, hospital or other
Collaborators: Sun Yat-Sen University Cancer Center
Study start: Oct 2026 (estimated)
Primary completion: Oct 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 17 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GMDTC Group	Experimental	Drug: GMDTC 1 mg/ml, Drug: GMDTC 2mg/ml, Drug: GMDTC 3mg/mlAll participants receive high-dose cisplatin chemotherapy (75mg/m2) on day 1 , followed by GMDTC administration via intravenous drip. The dosage is 0.5 grams per vial, in 1000 mg, 2000 mg, and 3000 mg once a day. The medication is administered once daily on Days 1-5 of each cycle. Among them, GMDTC starts to be administered 2 hours ± 15 minutes after the cisplatin administration on day 1. GMDTC is reconstituted and diluted with 0.9% sodium chloride injection before administration. The total volume of the liquid for the trial drug GMDTC infusion each day is 1000 ml.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

The subject is able to understand and voluntarily sign a written Informed Consent Form (ICF), agreeing to comply with the study protocol.
When signing the ICF, the participant must be at least 18 years of age, regardless of gender.
The expected survival period of the subjects is ≥ 6 months.
The subjects have an ECOG performance status score of 0 or 1.
Malignant solid tumors (excluding renal cell carcinoma) diagnosed by histological or cytological examination must simultaneously meet the following criteria:

Key exclusion criteria (37 listed)

Those who have participated in any other clinical trials within 4 weeks before the first administration of the investigational drug or within 5 half-lives (whichever is shorter);
Those who are known or suspected to be allergic to any active ingredient or excipient of this product, or who have a specific history of allergic reactions as determined by the investigator to be unsuitable for treatment with the investigational drug;
Those who are known or suspected to be allergic to any active ingredient or excipient of cisplatin or any other platinum-based drugs;
The researchers identified those participants who would require a dose adjustment of cisplatin upon their first administration after being included in the study.
Previous administration and toxicity recovery status:

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
GMDTC 1 mg/mlCohort 1: Participants will receive high-dose cisplatin chemotherapy (75mg/m2) on D1 each cycle. Subsequently, they received GMDTC at a concentration of 1 mg/ml via intravenous infusion, once daily for 5 days, over 2 cycles, and then underwent a 2-week follow-up after the last administration.	Drug	GMDTC Group
GMDTC 2mg/mlCohort 2: Participants will receive high-dose cisplatin chemotherapy (75mg/m2) on D1 each cycle. Subsequently, they received GMDTC at a concentration of 2 mg/ml via intravenous infusion, once daily for 5 days, over 2 cycles, and then underwent a 2-week follow-up after the last administration.	Drug	GMDTC Group
GMDTC 3mg/mlCohort 3: Participants will receive high-dose cisplatin chemotherapy (75mg/m2) on D1 each cycle. Subsequently, they received GMDTC at a concentration of 3 mg/ml via intravenous infusion, once daily for 5 days, over 2 cycles, and then underwent a 2-week follow-up after the last administration.	Drug	GMDTC Group

Primary outcome

Adverse events
Time frame: Up to 90 days
Adverse events will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, V6.0), which includes spontaneously reported adverse events as well as clinically significant changes in vital signs, physical examination, laboratory tests, electrocardiogram, and other examinations conducted during the trial.
DLT
Time frame: 21 days after the participant completes the first dose in the dose-escalation phase.
DLT is defined as any TEAE (including those definitely related, likely related, and possibly related) to GMDTC that occurs during the DLT observation period (the severity of adverse events [Adverse events, AE] is evaluated according to NCI CTCAE V6.0) or any clinically significant abnormal laboratory test results.
RP2D
Time frame: From first participant enrollment to the completion of the entire study, approximately 1 year.
RP2D is defined as the Recommended Phase 2 dose.

13 secondary outcomes

Pharmacokinetic parameters,Tmax
Time frame: Cycle 1 Days 1-5
Pharmacokinetic parameters, Cmax
Time frame: Cycle 1 Days 1-5
Pharmacokinetic parameters, λz
Time frame: Cycle 1 Days 1-5
Pharmacokinetic parameters, t1/2
Time frame: Cycle 1 Days 1-5
Pharmacodynamic parameters, urine platinum
Time frame: Baseline (the day before first dose) and Day1 to Day5 of each cycle.
Pharmacodynamic parameters, amount of platinum excreted in urine over 24 hours
Time frame: Baseline (the day before first dose) and Day1 to Day5 of each cycle.
Renal function indicators： creatinine clearance
Time frame: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Pharmacodynamic parameters,Urine platinum excretion rate
Time frame: Baseline (the day before first dose) and Day1 to Day5 of each cycle.
Renal function indicators：serum creatinine
Time frame: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：urea nitrogen/urea,
Time frame: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：estimated glomerular filtration rate (eGFR)
Time frame: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：cystatin C
Time frame: Baseline(Within 3 days before Cycle 1 treatment),D6 after the last cisplatin treatment prior to enrollment,D15 after the last cisplatin treatment prior to enrollment,Day 6 of each Cycle ,Day 15 of each Cycle,Day 20 of each Cycle
Renal function indicators：24-hour urine protein quantification
Time frame: Baseline (the day before first dose) ,Day 1of each Cycle

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 17 Sep 2026.
Background: PubMed 27282297Tang X, Zhu J, Zhong Z, Luo M, Li G, Gong Z, Zhang C, Fei F, Ruan X, Zhou J, Liu G, Li G, Olson J, Ren X. Mobilization and removing of cadmium from kidney by GMDTC utilizing renal glucose reabsorption pathway. Toxicol Appl Pharmacol. 2016 Aug 15;305:143-152. doi: 10.1016/j.taap.2016.06.001. Epub 2016 Jun 6.
Background: PubMed 18272962Pabla N, Dong Z. Cisplatin nephrotoxicity: mechanisms and renoprotective strategies. Kidney Int. 2008 May;73(9):994-1007. doi: 10.1038/sj.ki.5002786. Epub 2008 Feb 13.
Background: PubMed 17700201Yao X, Panichpisal K, Kurtzman N, Nugent K. Cisplatin nephrotoxicity: a review. Am J Med Sci. 2007 Aug;334(2):115-24. doi: 10.1097/MAJ.0b013e31812dfe1e.
Background: PubMed 18334097Esteban-Fernandez D, Verdaguer JM, Ramirez-Camacho R, Palacios MA, Gomez-Gomez MM. Accumulation, fractionation, and analysis of platinum in toxicologically affected tissues after cisplatin, oxaliplatin, and carboplatin administration. J Anal Toxicol. 2008 Mar;32(2):140-6. doi: 10.1093/jat/32.2.140.
Background: PubMed 23404427Astolfi L, Ghiselli S, Guaran V, Chicca M, Simoni E, Olivetto E, Lelli G, Martini A. Correlation of adverse effects of cisplatin administration in patients affected by solid tumours: a retrospective evaluation. Oncol Rep. 2013 Apr;29(4):1285-92. doi: 10.3892/or.2013.2279. Epub 2013 Feb 6.
Background: PubMed 17625587Kelland L. The resurgence of platinum-based cancer chemotherapy. Nat Rev Cancer. 2007 Aug;7(8):573-84. doi: 10.1038/nrc2167. Epub 2007 Jul 12.
Background: PubMed 22069563Miller RP, Tadagavadi RK, Ramesh G, Reeves WB. Mechanisms of Cisplatin nephrotoxicity. Toxins (Basel). 2010 Nov;2(11):2490-518. doi: 10.3390/toxins2112490. Epub 2010 Oct 26.
Background: PubMed 12509415Mandic A, Hansson J, Linder S, Shoshan MC. Cisplatin induces endoplasmic reticulum stress and nucleus-independent apoptotic signaling. J Biol Chem. 2003 Mar 14;278(11):9100-6. doi: 10.1074/jbc.M210284200. Epub 2002 Dec 31.
Background: PubMed 31240907Ge Y, Zheng N, Chen X, Zhu J, Sun W, Olson JR, Aga DS, Hu W, Tang X, Ren X. GMDTC Chelating Agent Attenuates Cisplatin-Induced Systemic Toxicity without Affecting Antitumor Efficacy. Chem Res Toxicol. 2019 Aug 19;32(8):1572-1582. doi: 10.1021/acs.chemrestox.9b00097. Epub 2019 Jul 9.
The resurgence of platinum-based cancer chemotherapyLink provided by the sponsor.
GMDTC Chelating Agent Attenuates Cisplatin-Induced Systemic Toxicity without Affecting Antitumor EfficacyLink provided by the sponsor.
Cisplatin induces endoplasmic reticulum stress and nucleus-independent apoptotic signalingLink provided by the sponsor.
Correlation of adverse effects of cisplatin administration in patients affected by solid tumours: a retrospective evaluationLink provided by the sponsor.
Mechanisms of Cisplatin nephrotoxicityLink provided by the sponsor.
Accumulation, fractionation, and analysis of platinum in toxicologically affected tissues after cisplatin, oxaliplatin, and carboplatin administrationLink provided by the sponsor.
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.

Li Zhang, Doctor of Medicine contact

＋86 020-87343458

zhangli@syscc.org.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 37 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Li Zhang, Doctor of Medicine (＋86 020-87343458, zhangli@syscc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07824843, which also lists 9 linked publications.

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 17 Sep 2026.