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TSN222 in Subjects With Advanced Solid Tumors or Lymphomas

NCT05842785 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-07-29

No results posted yet for this study

Summary

The study is a first-in-human \[FIH\], open-label phase 1/2 study of TSN222 in subjects with advanced solid tumors or lymphomas. This study is comprised of a Phase 1 dose escalation and Phase 2 dose expansion component.

Conditions

  • Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or Lymphoma

Interventions

DRUG

Phase I dose escalation

The eligible subjects will receive TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

DRUG

Phase II-HNSCC

The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

DRUG

Phase II-Advanced melanoma

The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

DRUG

Phase II-solid tumors or lymphomas

The eligible subjects will receive RP2D of TSN222 via intratumoral (i.t.) injection on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Tyligand Bioscience (Shanghai) Limited

    lead INDUSTRY

Principal Investigators

  • Jian Zhang · Fudan Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-26
Primary Completion
2025-06-01
Completion
2026-06-01
FDA Drug
Yes

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 NCT05842785 on ClinicalTrials.gov