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Clinical Trials in China / NCT06640049
Active, not recruiting Phase 2

A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

NCT06640049 · tracked via the Priya Life Science China tracker
Sponsor
GlaxoSmithKline
Phase
Phase 2
Started
2024-10-17
Last updated
2025-11-17

Condition(s) studied

Neoplasms, Rectal

Investigational drug(s) / intervention(s)

Dostarlimab

Dostarlimab: Dostarlimab will be administered.

Study summary

The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal adenocarcinoma * Participant has radiologically and endoscopically evaluable disease * Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment Exclusion Criteria: * Participant has distant metastatic disease * Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer * Has a known additional malignancy that progressed or required active treatment within the past 2 years * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3, immune-related severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade \[SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemic symptoms)\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary * Has any history of interstitial lung disease or pneumonitis * Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant) * Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
GSK Investigational Site Chengdu China
GSK Investigational Site Chongqing China
GSK Investigational Site Guangzhou China
GSK Investigational Site Guangzhou China
GSK Investigational Site Hangzhou China
GSK Investigational Site Hangzhou China
GSK Investigational Site Jinan China
GSK Investigational Site Kunming China
GSK Investigational Site Shanghai China

More GlaxoSmithKline trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06640049 on ClinicalTrials.gov ↗ ← All trials in China