CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 162 target
Drug / intervention
Phase I dose escalation +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05842785
NCT05842785Phase 2RecruitingUpdate OverdueUpdated 23mo ago · Completion was 13mo ago
Enrollment Stalled
Update Overdue

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of TSN222 in Subjects With Advanced Solid Tumors or Lymphoma

Tyligand Bioscience (Shanghai) Limited·interventional·Posted May 6, 2023·Updated Jul 29, 2024

In Brief

A Phase 2 clinical trial evaluating Phase I dose escalation, Phase II-HNSCC, and 2 other interventions for Has a Pathologically Documented Unresectable Locally Advanced or Metastatic Solid Tumor or Lymphoma. Currently recruiting, targeting 162 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
202420252026
First PostedMay 6, 2023
Enrollment StartJul 26, 2023
Primary CompletionJun 1, 2025
Study CompletionJun 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 3.2 years ago

Interventions

Phase I dose escalationdrug

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.

Phase II-HNSCCdrug

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.

Phase II-Advanced melanomadrug

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.

Phase II-solid tumors or lymphomasdrug

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.