Phase 2 Trial Of S-531011 With RadScopal In Previously Treated Metastatic Colorectal Cancer

NCT07720115 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 2026-0621NCI-2026-05490
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if the experimental drug S-531011 plus RadScopalTM radiation therapy can help to control previously treated metastatic colorectal cancer.

Conditions

Phase II; S-531011; RadScopal; Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with S-531011 + RadScopal XRT

EXPERIMENTAL

Drug: S-531011; Radiation: HD-XRT

Interventions

S-531011 DRUG

Given by IV

Treatment with S-531011 + RadScopal XRT

HD-XRT RADIATION

Given by radiation

Also known as: RadScopal XRT

Treatment with S-531011 + RadScopal XRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Daniel Haldar, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: August 12, 2026
• Primary Completion: September 4, 2026
• Study Completion: September 4, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

US (1)