A Phase 1/2 Study of TY101 for Locally Advanced /Metastatic Solid Tumors and Relapsed or Refracto… (NCT04458389) | Clinical Trial Compass
UnknownPhase 1/2
A Phase 1/2 Study of TY101 for Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas
China268 participantsStarted 2020-12-07
Plain-language summary
A multicenter, open-label, dose-escalation and dose-expansion phase 1/2 study, to evaluate TY101 safety, tolerability, pharmacokinetic characteristics, effectiveness and immunogenicity in patients with Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas. The study includes two parts: dose escalation and expansion cohort to evaluate the tolerability and efficacy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female ≥18 years
✓. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
✓. Histological or cytological diagnosis, advanced solid tumor and lymphoma(Dose escalation phase), Or recurrence and refractory peripheral T-cell lymphoma who must have failure at least 1 prior routine regimen, or failure to tolerate the toxicity, or lack of any routine regimens, advanced squamous cell carcinoma of the skin and other advanced solid tumors and lymphoma (Dose expansion phase）
✓. At least one evaluable lesion for solid tumor or lymphoma.
✓. Must provide with tumor specimen that meet the requirements for biomarker testing(expression of PD-L1 and the infiltrating lymphocytes).
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the screening and without deterioration within 2 weeks before enrollment.
✓. Life expectancy ≥12 weeks
✓. Adequate organ function as evidenced by meeting all the following requirements (with 14 days):
Exclusion criteria
✕. Previously received any of the following therapies:
✕.1 Received any other cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose; for nitrosoureas and mitomycin C at least 6 weeks.
✕
What they're measuring
1
Safety and Tolerability measured
Timeframe: 90 days after the last dose.
2
Dose-limiting toxicity(DLT)
Timeframe: 3 weeks after first dose for each dose group.
Trial details
NCT IDNCT04458389
SponsorTayu Huaxia Biotech Medical Group Co., Ltd.
.2 Received any targeted or other anticancer drug therapy within 4 weeks prior to the first dose.
✕.3 Radiation therapy within 4 weeks prior to first dose (note: palliative radiotherapy for bone or palliative radiotherapy for superficial lesions was allowed, the course of treatment is based on local standards and had been ended 2 weeks before the first dose. Radiotherapy covering more than 30% of the bone marrow area within 4 weeks prior to first dose was excluded).
✕.4 NMPA-approved antitumor Chinese traditional medicine is in use or has been used within 2 weeks prior to the first dose.
✕. Concurrent malignancy within 5 years prior to screening, except for the cured basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
✕. Patients with active central nervous system (CNS) metastasis and/or cancerous meningitis who were found on known or in the screening tests, except for the following subjects: Subjects with asymptomatic brain metastasis who need to undergo regular brain imaging examination as the site of the disease. Subjects with stable status of brain metastasis after treatment.
✕. Concomitant active or suspected autoimmune disease; but patients who are in a stable state and did not require systemic immunosuppressive therapy are allowed to be enrolled.