OncoMatch/Clinical Trials/NCT05156203
Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
Is NCT05156203 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies T-1301 Capsules for advanced solid tumor.
Treatment: T-1301 Capsules — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: major surgery
Major surgery within 4 weeks prior to the first dose of study drug
Cannot have received: definitive radiation therapy
Anti-cancer definitive radiation therapy (4,000-6,000 cGy) within 4 weeks prior to the first dose of study drug
Cannot have received: palliative radiation
Palliative radiation (≤ 10 fractions with total dose < 3,000 cGy) within 2 weeks prior to the first dose of study drug
Cannot have received: systemic cytotoxic chemotherapy
Any systemic cytotoxic chemotherapy within 4 weeks prior to the first dose of study drug
Cannot have received: targeted therapy
Any targeted therapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first dose of study drug
Cannot have received: immunotherapy
Any immunotherapy within 4 weeks prior to the first dose of study drug
Cannot have received: interventional treatment in another clinical trial
Any interventional treatments in another clinical trial following Exclusion Criteria 2c, 2d and 2e
Cannot have received: blood transfusion
Subjects received blood transfusion ... within 2 weeks prior to the first dose of study drug
Cannot have received: biological response modifiers (G-CSF)
Subjects received ... biological response modifiers (e.g., G-CSF) within 2 weeks prior to the first dose of study drug
Cannot have received: autologous bone marrow transplant or stem cell rescue
Subject who received autologous bone marrow transplant or stem cells rescue within 6 months prior to the first dose of study drug
Lab requirements
Blood counts
ANC ≥ 1500/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9.0 g/dL
Kidney function
Creatinine clearance (CrCl) ≥ 50 mL/min
Liver function
ALT ≤ 3 x ULN; total serum bilirubin ≤ 1.5 x ULN
Adequate organ function as defined by the following criteria: Serum alanine transaminase (ALT) ≤ 3 x ULN; Total serum bilirubin ≤ 1.5 x ULN; Absolute neutrophil count (ANC) ≥ 1500/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9.0 g/dL; Creatinine clearance (CrCl) ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify