Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaivex Therapeutics Corporation
About this trial
T-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1, first-in-human (FIH) clinical trial in subjects with advanced cancer.
This study is an open-label, multi-center, Phase I dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of T-1301 capsules in subjects with advanced solid tumors (including lymphoma), and to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Approximately 30 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until the MTD is reached.
T-1301 will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts. Subjects can continue with the treatment until one of the discontinuation criteria is met or until the planned stop of the study (12 months after the last subject receives the first dose of study drug), whichever comes first.
The planned dose levels are: 10, 20, 40, 60, 80, 100, 120, 140 and 160 mg/day. The dosing schedule will be once daily (QD) at the first dose level (10 mg/day) and be changed to twice daily (BID) starting with the second dose level. Other dose levels or dosing frequency may be explored based on safety and related drug exposure data following the decision of Safety Review Committee.
The dose escalation will follow accelerated titration and the Bayesian optimal interval (BOIN) design. During the initial accelerated titration phase, one (1) subject is enrolled per dose level. In the subsequent phase when the BOIN design is used, subjects will be enrolled in cohorts of size 3-6.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
Subjects with histologically and cytologically confirmed advanced solid tumors (including lymphoma) that are refractory to standard treatments, or for whom no standard treatment is available, or who are not amenable or unwilling to receive standard treatments.
Solid tumors that are measurable or evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy.
Have a life expectancy of ≥ 3 months in the Investigator's opinion.
Disqualifiers
Major surgery within 4 weeks prior to the first dose of study drug.
Anti-cancer definitive radiation therapy (4,000-6,000 cGy) within 4 weeks prior to the first dose of study drug.
Palliative radiation (≤ 10 fractions with total dose < 3,000 cGy) within 2 weeks prior to the first dose of study drug.
Any systemic cytotoxic chemotherapy within 4 weeks prior to the first dose of study drug.
Trial design
Design model
Sequential
Treatments tested in this trial
T-1301 Capsules
DrugT-1301 Capsules, 10 and 50 mg, are opaque hard gelatin capsules for oral administration.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: T-1301 CapsulesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD)
The MTD will be selected based on isotonic regression as specified in Liu and Yuan (2015). Specifically, the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate is selected as the MTD. If there are ties, the higher dose level is selected when the isotonic estimate is lower than the target toxicity rate and the lower dose level is selected when the isotonic estimate is greater than or equal to the target toxicity rate. The target toxicity rate for the MTD is 30% and the MTD will be determined based on the occurrence of the dose-limiting toxicity (DLT) assessed using toxicity data during Cycle 1 (the first 28 days).
Time frame
First treatment cycle (i.e., the first 28 days post the first dose)2
Recommended phase 2 dose (RP2D)
The recommended Phase 2 Dose (RP2D) will not exceed the MTD and will be determined by the Safety Review Committee.
Time frame
First treatment cycle (i.e., the first 28 days post the first dose)3
Frequency, types, severity and relationship to study drug of adverse events (AEs)
Safety and tolerability
Time frame
At least 84 days (i.e., 56 days for two treatment cycles and 28 days for safety follow-up)Secondary outcomes
1
Pharmacokinetic parameters: Cmax
The maximum plasma concentration of T-1301 derived from the plasma concentration-time profiles
Time frame
Selected time points during the first 28-day treatment cycle2
Pharmacokinetic parameters: Ctrough
The plasma concentration of T-1301 at trough level derived from the plasma concentration-time profiles
Time frame
Selected time points during the first 28-day treatment cycle3
Pharmacokinetic parameters: Tmax
The time to reach maximum concentration of T-1301 derived from the plasma concentration-time profiles
Time frame
Selected time points during the first 28-day treatment cycle4
Pharmacokinetic parameters: Area Under Curve (AUC)
The area under the concentration versus time curve of T-1301 derived from the plasma concentration-time profiles
Time frame
Selected time points during the first 28-day treatment cycleSponsors and contacts
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Source ClinicalTrials.gov