The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. The main questions it aims to answer are:
* The Maximum tolerated dose (MTD) of T-1201 on different dosing schedules. * The Recommended Phase 2 dose (RP2D) of T-1201 on different dosing schedules.
Researchers will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201.
Participants will:
Received T-1201 either once every 4 (Part A)/2 (Part B)/3 (Part C) weeks, depend on they participate in which parts of study.
Visit the clinic once every 2/3 weeks for checkups and tests
Signed and dated informed consent form.
Histologically and cytologically confirmed advanced malignancies that are refractory to standard therapy or have no accepted standard therapy.
Solid tumors that are measurable or evaluable as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion).
Female or male, 20 years of age or older.
Clinically significant comorbidity such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (>160/100 mmHg despite optimal medical treatment), chronic obstructive pulmonary disease (COPD) with frequent exacerbations, refractory asthma, inflammatory bowel disease or intestinal obstruction.
Acute myocardial infarction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.
Central nervous system (CNS) metastasis or seizure disorder due to underlying malignancy except those who have been treated and have stable CNS metastases or are asymptomatic.
AIDS-defining opportunistic infections within the past 12 months.
Sequential
T-1201 Injection 100 mg Kit
DrugT-1201 Injection 100 mg Kit contains lyophilized powder with a sterile aqueous solution formulated for intravenous administration.
Maximum tolerated dose (MTD)
MTD is highest dose level in which 6 patients have been treated with at most 1 experiencing dose limiting toxicity (DLT).
Recommended Phase 2 dose (RP2D) dose (RP2D)
To determine the recommended Phase 2 dose (RP2D)
Frequency, type, severity and relationship to study drug of adverse events (AEs)
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
Pharmacokinetic profiles: Cmax of T-1201 and its metabolite(s) [0060 and SN-38]
Maximum plasma concentration (Cmax ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.
Pharmacokinetic profiles: Tmax of T-1201 and its metabolite(s) [0060 and SN-38]
Time to reach maximum concentration (Tmax ) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.
Pharmacokinetic profiles: MRT of T-1201 and its metabolite(s) [0060 and SN-38]
Mean residence time (MRT) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.
Pharmacokinetic profiles: AUC of T-1201 and its metabolite(s) [0060 and SN-38]
The area under the plasma concentration-time curve (AUC) of T-1201, 0060, and SN-38 from plasma concentration-time profiles.
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