Neoplasms, RectalPhase 2China AZUR-1NCT06640049
A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
A Phase 2 study testing Dostarlimab in people with Neoplasms, Rectal, run by GlaxoSmithKline at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Rectal
- What is being tested?
- Dostarlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 9 sitesChina
- Study dates
- 17 Oct 2024to 15 Apr 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
GSK Investigational Site
Chengdu, 610041
GSK Investigational Site
Chongqing, 400010
GSK Investigational Site
Guangzhou, 510060
GSK Investigational Site
Guangzhou, 510655
GSK Investigational Site
Hangzhou, 310016
GSK Investigational Site
Hangzhou
GSK Investigational Site
Jinan, 250117
GSK Investigational Site
Kunming, 650106
GSK Investigational Site
Shanghai, 200032
About this study
Official title: A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer in China
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.
- Conditions
- Neoplasms, Rectal
- Being tested
- Dostarlimab
- Keywords
- Dostarlimab, GSK4057190A, TSR-042, Rectal cancer, dMMR, MSI-H
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabBiological
Also called GSK4057190A, TSR-042
Dostarlimab will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab monotherapy | Experimental | Participants will receive dostarlimab as monotherapy. Receives: Biological: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Independent central review (ICR) for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months.
Measured: 18 months
Secondary outcomes (19)
Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR
cCR24 is achieved when a participant maintains cCR as assessed by ICR for 24 months following their first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 24 months of assessment time, amounting to a total of 30 months.
Measured: 30 months
Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR
cCR36 is achieved when a participant maintains cCR as assessed by ICR for 36 months following first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 36 months of assessment time, amounting to a total of 42 months.
Measured: 42 months
Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator
EFS3 is defined as participants who remained alive and free of disease progression precluding surgery, local recurrence, and distant recurrence at 3 years from the first dose of study intervention as assessed by Investigator.
Measured: 3 years
Event Free Survival (EFS) as assessed by Investigator
EFS is defined as time from the date of first dose of study intervention to any of the following events including progression of disease that precludes surgery, local recurrence, distant recurrence (all as assessed by the investigator), or death due to any cause.
Measured: Up to approximately 77 months
Number of Participants with cCR12 as assessed by Investigator
cCR12 is achieved when a participant maintains cCR as assessed by Investigator for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months.
Measured: 18 Months
Number of Participants with cCR24 as assessed by Investigator
cCR24 is achieved when a participant maintains cCR as assessed by Investigator for 24 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 24 months of assessment time, amounting to a total of 30 months.
Measured: 30 Months
Number of Participants with cCR36 as assessed by Investigator
cCR36 is achieved when a participant maintains cCR as assessed by Investigator for 36 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 36 months of assessment time, amounting to a total of 42 months.
Measured: 42 Months
Objective Response Rate (ORR) assessed by ICR
ORR is defined as number of participants achieving a partial response (PR), near complete response (nCR) or cCR at post-intervention disease assessment (PIDA) or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or incomplete clinical response (iCR) (PIDA 2) as assessed by ICR.
Measured: Up to 37 Weeks
Objective Response Rate (ORR) as assessed by Investigator
ORR by Investigator is defined as number of participants achieving a PR, nCR, or cCR at PIDA.
Measured: Up to 37 Weeks
Organ Preservation Rate
Organ Preservation Rate is defined as number of participants who did not undergo any rectal cancer surgery either as primary management or for local recurrence, or who did not have a permanent colostomy created, at any time up to 3 years.
Measured: Up to 3 years
Disease-Specific Survival (DSS)
DSS is defined as time from the date of first dose of study intervention to death due to disease under study.
Measured: Up to approximately 77 months
Disease-Specific Response at 5 years (DSS5)
DSS5 is defined as the number of participants not dying due to disease under study at 5 years from the first dose of study intervention.
Measured: Up to 5 years
Overall Survival (OS)
OS is defined as time from first dose of study intervention to death from any cause.
Measured: Up to approximately 77 months
Overall Survival at 5 years (OS5)
OS5 is defined as number of participants being alive at 5 years from first dose of study intervention.
Measured: Up to 5 years
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune related Adverse Events (irAEs) and AEs leading to death or discontinuation of study intervention.
Measured: Up to approximately 77 months
Serum concentration of Dostarlimab
Measured: Up to approximately 77 months
Concentration at the end of infusion (C-EOI) of Dostarlimab
Measured: Up to approximately 77 months
Trough Concentration (C-trough) of Dostarlimab
Measured: Up to approximately 77 months
Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab
Measured: Up to approximately 77 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start17 Oct 2024
- Primary completion24 Oct 2027 (estimated)
- Study completion15 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, RectalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640049
- Sponsor's protocol ID
- 221972
- Acronym
- China AZUR-1
- Status last verified
- Nov 2025
- First submitted
- 10 Oct 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer in China
- ClinicalTrials.gov ID
- NCT06640049
- Acronym / sponsor ID
- China AZUR-1 / 221972
- Conditions
- Neoplasms, Rectal
- Keywords
- Dostarlimab, GSK4057190A, TSR-042, Rectal cancer, dMMR, MSI-H
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 24 Oct 2027 (estimated)
- Study completion
- 15 Apr 2031 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab monotherapy | Experimental | Biological: DostarlimabParticipants will receive dostarlimab as monotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabAlso: GSK4057190A, TSR-042Dostarlimab will be administered. | Biological | Dostarlimab monotherapy |
Primary outcome
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
Time frame: 18 months
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Independent central review (ICR) for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months.
19 secondary outcomes
Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR
Time frame: 30 months
Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR
Time frame: 42 months
Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator
Time frame: 3 years
Event Free Survival (EFS) as assessed by Investigator
Time frame: Up to approximately 77 months
Number of Participants with cCR12 as assessed by Investigator
Time frame: 18 Months
Number of Participants with cCR24 as assessed by Investigator
Time frame: 30 Months
Number of Participants with cCR36 as assessed by Investigator
Time frame: 42 Months
Objective Response Rate (ORR) assessed by ICR
Time frame: Up to 37 Weeks
Objective Response Rate (ORR) as assessed by Investigator
Time frame: Up to 37 Weeks
Organ Preservation Rate
Time frame: Up to 3 years
Disease-Specific Survival (DSS)
Time frame: Up to approximately 77 months
Disease-Specific Response at 5 years (DSS5)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to approximately 77 months
Overall Survival at 5 years (OS5)
Time frame: Up to 5 years
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune related Adverse Events (irAEs) and AEs leading to death or discontinuation of study intervention.
Time frame: Up to approximately 77 months
Serum concentration of Dostarlimab
Time frame: Up to approximately 77 months
Concentration at the end of infusion (C-EOI) of Dostarlimab
Time frame: Up to approximately 77 months
Trough Concentration (C-trough) of Dostarlimab
Time frame: Up to approximately 77 months
Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab
Time frame: Up to approximately 77 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dostarlimab in people with Neoplasms, Rectal, run by GlaxoSmithKline at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.