CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 35 target
Drug / intervention
Toripalimabdrug
Likely dose
Toripalimab 240mgfrom record
Key inclusion· 10
  • ✓Histologically or cytologically proven advanced solid tumors not responding to standard therapy
  • ✓Germline or somatic mutations in POLE or POLD (excluding synonymous mutations)
  • ✓MSS or MSI-L or pMMR status
  • ✓Willing to refuse conventional chemotherapy or targeted therapy
Key exclusion· 18
  • ✕Confirmed or suspected brain metastases
  • ✕Cancerous meningitis
  • ✕MSI-H or dMMR status
  • ✕Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors

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

Search/NCT03810339
NCT03810339Phase 2RecruitingOn TrackUpdated 2mo ago
Long Recruiting
CompareCT.gov

A Phase II Open Label Study of Toripalimab, a PD-1 Antibody, in Participants With POLE or POLD-1 Mutated and Non-MSI-H Advanced Solid Tumors

Sun Yat-sen University·interventional·Posted Jan 18, 2019·Updated Apr 23, 2026

In Brief

A Phase 2 clinical trial evaluating Toripalimab for Solid Tumor and Advanced Cancer. Currently recruiting, targeting 35 participants across 4 sites.

Detailed Summary

The purpose of this study is to evaluate the response of toripalimab (JS001), a PD1 antibody, in participants with POLE or POLD-mutated and non microsatellite instability (non-MSI-H) advanced solid cancers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Advanced Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
201920202021202220232024202520262027202820292030
First PostedJan 18, 2019
Enrollment StartJan 15, 2019
Primary CompletionJan 15, 2028
Study CompletionDec 31, 2029
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 7.5 years agoPrimary completion in 1.5 years

Interventions

Toripalimabdrug

Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity