NCT07511023

Brief Summary

To look at the effectiveness of sacituzumab tirumotecan (MK-2870) in treating participants with treatment-refractory unresectable and/or metastatic anal/rectal cancer.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
78mo left

Started Sep 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

October 2, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

March 31, 2026

Last Update Submit

September 30, 2026

Conditions

Phase 2Sacituzumab TirumotecanRefractory MetastaticUnresectable SquamousCell Carcinoma of the Anus/ Rectum

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)

Phase 2: Treatment with Sacituzumab Tirumotecan

EXPERIMENTAL

Treatment with sacituzumab tirumotecan will occur until clinical or radiographic progression,unacceptable toxicity, withdrawal of consent for study participation.

Drug: Sacituzumab Tirumotecan

Interventions

Sacituzumab TirumotecanDRUG

Given by IV

Phase 2: Treatment with Sacituzumab Tirumotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history or inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular disease within 6 months before the first dose of study intervention.
  • Exposure to prior systemic anticancer therapy or radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis.
  • Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
  • Receipt of any other investigational agent(s) or investigational device within 4 weeks before the first dose of study intervention.
  • Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.
  • Prior treatment with a topoisomerase 1 inhibitor-containing ADC.
  • Prior treatment with irinotecan or topotecan.
  • Prior treatment with a TROP2-targeted ADC.
  • Receipt of a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Treatment with strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.
  • Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \<10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Van Morris, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Van Morris, MD

CONTACT

MorrisGIClinicalTrials@mdanderson.org

Study Design

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

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 6, 2026

Study Start

September 25, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2033

Last Updated

October 2, 2026

Record last verified: 2026-03

Locations

US(1)