NCT06640049 (China AZUR-1) is a Phase 2 clinical trial of Dostarlimab in Neoplasms, Rectal, sponsored by GlaxoSmithKline.

Who is sponsoring NCT06640049?

NCT06640049 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT06640049?

Interventions in NCT06640049: Dostarlimab.

What condition does NCT06640049 study?

NCT06640049 studies Neoplasms, Rectal.

Is NCT06640049 still recruiting?

NCT06640049 is currently active, enrolled. Last updated 17 November 2025.

Last reviewed 2025-11-17 · How we verify

NCT06640049: China AZUR-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 2 Last updated 17 November 2025

What this trial tests

Phase 2 trial testing Dostarlimab in Neoplasms, Rectal in 23 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 October 2024

Primary endpoint
24 October 2027

15 April 2031

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	17 October 2024
Primary completion	24 October 2027
Estimated completion	15 April 2031
Sites	9 locations across China

Drugs / interventions tested

Dostarlimab (DOSTARLIMAB) — full drug profile →

Conditions studied

Neoplasms, Rectal — all drugs for Neoplasms, Rectal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Neoplasms, Rectal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Dostarlimab

Trials testing the same drug.

NCT07408063 — A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Res · Phase 2 · not yet recruiting
NCT07381777 — XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Lo · Phase 2 · not yet recruiting
NCT06405230 — Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Or · Phase 1, PHASE2 · recruiting
NCT07336147 — Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine · Phase 2 · recruiting
NCT07108270 — A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recur · Phase 2 · recruiting

Other recruiting trials for Neoplasms, Rectal

Currently open trials in the same condition.

NCT05723562 — A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer · Phase 2 · active not recruiting
NCT03573791 — Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06640049 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 17 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06640049.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing