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A Phase 1/2 Study of TY101 for Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas

NCT04458389 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2021-08-13

No results posted yet for this study

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.

Conditions

  • Locally Advanced /Metastatic Solid Tumors
  • Relapsed or Refractory Lymphomas

Interventions

DRUG

TY101

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.

Sponsors & Collaborators

  • Tayu Huaxia Biotech Medical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2024-06-30
Completion
2025-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458389 on ClinicalTrials.gov