Phase IIPhase 2NCT07720115
Phase 2 Trial Of S-531011 With RadScopal In Previously Treated Metastatic Colorectal Cancer
A Phase 2 study testing S-531011 and HD-XRT in people with Phase II and S-531011, run by M.D. Anderson Cancer Center.
Trial summary
To learn if the experimental drug S-531011 plus RadScopalTM radiation therapy can help to control previously treated metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- S-531011 and HD-XRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2026to 4 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- Prior treatment with an anti-CCR8 antibody.
- Tumor occupying >80% of total liver volume, as assessed by the investigator and/or treating radiation oncologist.
- Prior XRT to the target lesion(s) selected for HD-XRT.
- Prior organ or tissue allograft.
- Presence or history of immunodeficiency that requires chronic use of systemic corticosteroids (≥ 10mg of prednisone equivalent per day) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids or immunosuppressive drugs).
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- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Any anticancer therapy within the past 4 weeks before enrollment.
- Extended field radiation within the past 4 weeks or limited field radiation within the past 2 weeks before enrollment.
- Participants who have not recovered from adverse events due to prior anticancer therapy (i.e. >grade 2 residual toxicities) with the exception of alopecia and platinum-induced peripheral neuropathy.
- Active brain metastases, unless adequately treated and participant is neurologically stable (except for residual symptoms of central nervous system treatment) for at least 2 weeks prior to enrollment without corticosteroids or are on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent).
- Presence of symptomatic leptomeningeal disease.
- Clinically significant cardiac, respiratory, or other medical or psychiatric conditions that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator.
- Pregnant women are excluded from this study because S-531011 is an agent with the potential for teratogenic or abortifacient effects.
About this study
To learn if the experimental drug S-531011 plus RadScopalTM radiation therapy can help to control previously treated metastatic colorectal cancer.
Read the detailed description
Primary Objective To evaluate the efficacy of S-531011 + RadScopalTM XRT in previously treated metastatic non-MSI-H CRC participants, as defined by the objective response rate (ORR) per RECIST v1.1.
- Conditions
- Phase II, S-531011, RadScopal, Metastatic Colorectal Cancer
- Being tested
- S-531011, HD-XRT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-531011Drug
Given by IV
HD-XRTRadiation
Also called RadScopal XRT
Given by radiation
| Study group | Role | What they receive |
|---|---|---|
| Treatment with S-531011 + RadScopal XRT | Experimental | Not described Receives: Drug: S-531011; Radiation: HD-XRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start12 Aug 2026
- Primary completion4 Sep 2026 (estimated)
- Study completion4 Sep 2026 (estimated)
Why it stopped: 0 participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase IIStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Haldar, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720115
- Sponsor's protocol ID
- 2026-0621
- Other IDs
- NCI-2026-05490
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial Of S-531011 With RadScopal In Previously Treated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07720115
- Acronym / sponsor ID
- 2026-0621
- Conditions
- Phase II, S-531011, RadScopal, Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- 4 Sep 2026 (estimated)
- First posted
- 22 Jul 2026 (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.
To learn if the experimental drug S-531011 plus RadScopalTM radiation therapy can help to control previously treated metastatic colorectal cancer.
Detailed description
Primary Objective To evaluate the efficacy of S-531011 + RadScopalTM XRT in previously treated metastatic non-MSI-H CRC participants, as defined by the objective response rate (ORR) per RECIST v1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with S-531011 + RadScopal XRT | Experimental | Drug: S-531011, Radiation: HD-XRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Prior treatment with an anti-CCR8 antibody.
- Tumor occupying >80% of total liver volume, as assessed by the investigator and/or treating radiation oncologist.
- Prior XRT to the target lesion(s) selected for HD-XRT.
- Prior organ or tissue allograft.
- Presence or history of immunodeficiency that requires chronic use of systemic corticosteroids (≥ 10mg of prednisone equivalent per day) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
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 |
|---|---|---|
| S-531011Given by IV | Drug | Treatment with S-531011 + RadScopal XRT |
| HD-XRTAlso: RadScopal XRTGiven by radiation | Radiation | Treatment with S-531011 + RadScopal XRT |
Primary outcome
safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Daniel Haldar, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-531011 and HD-XRT in people with Phase II and S-531011, run by M.D. Anderson Cancer Center.
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 0 inclusion and 14 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: withdrawn, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). 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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.