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.
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.
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.
Single group
GMDTC 1 mg/ml
DrugCohort 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/ml
DrugCohort 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/ml
DrugCohort 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.
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.
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.
RP2D
RP2D is defined as the Recommended Phase 2 dose.
Pharmacokinetic parameters,Tmax
Peak time, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Pharmacokinetic parameters, Cmax
Peak concentrations, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
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.
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.
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Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
