A Phase 1/2 Study of TY101 for Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas
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|ClinicalTrials.gov Identifier: NCT04458389|
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced /Metastatic Solid Tumors Relapsed or Refractory Lymphomas||Drug: TY101||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||268 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||TY101 injection|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 (Dose Escalation)/Phase 2 (Expansion Cohort) Trial of TY101 as a Single Agent in Patients With Locally Advanced/Metastatic Solid Tumors and Relapsed or Refractory Lymphomas|
|Estimated Study Start Date :||August 31, 2020|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||July 31, 2025|
Dose escalation：Humanized anti-PD-1 monoclonal antibody is to be injected intravenously 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg 200mg (fix dose) until disease progresses or unacceptable tolerability occurs.
Dose expansion：After completion of the DLT observation, the sponsor and principal investigator will select a possible dose（RP2D）for dose expansion to further confirm the efficacy and safety of RP2D.
Dose escalation: TY101 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg 200mg Intravenous Q3W, 2 years depending on response.
Dose expansion: Subjects received TY101 injection for a maximum of 2 years until progressive disease, intolerant toxicity, death, or withdrawal from the study occurred.
- Safety and Tolerability measured [ Time Frame: 90 days after the last dose. ]Number of Participants with treatment-related Adverse Events (AEs) by CTCAE v5.0.
- Dose-limiting toxicity(DLT) [ Time Frame: 3 weeks after first dose for each dose group. ]DLT is the primary endpoint for safety in the dose escalation phase and will be used to determine the maximum tolerated dose (MTD).
- Pharmacokinetics(Cmax) [ Time Frame: Up to approximately 12 months ]Maximum Concentration(Cmax)
- Pharmacokinetics(Tmax) [ Time Frame: Up to approximately 12 months ]Dose escalation: Peak time(Tmax)
- Pharmacokinetics(AUC) [ Time Frame: Up to approximately 12 months ]Dose escalation: Area Under Curve(AUC)
- Pharmacokinetics(t1/2) [ Time Frame: Up to approximately 12 months ]Dose escalation: half life(t1/2)
- Pharmacokinetics(PPK) [ Time Frame: The PPK evaluation will be further designed based on the results of the dose escalation phase. ]Dose escalation: Population pharmacokinetics(PPK)
- Objective response rate(ORR) [ Time Frame: Up to approximately 12 months ]Efficacy observation
- Overall Survival(OS) [ Time Frame: Up to approximately 12 months ]Efficacy observation
- Progression-free survival(PFS) [ Time Frame: Up to approximately 12 months ]Efficacy observation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458389
|Contact: Guanwen Zeng, PhDfirstname.lastname@example.org|
|Cancer Hospital Chinese Academy of Medical Science|
|Beijing, Beijing, China, 100021|
|Contact: Yuankai Shi, PhD.MD 010-87788701 email@example.com|
|Principal Investigator: Yuankai Shi, PhD.MD|