A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With Leiomyosarcoma
Public ClinicalTrials.gov record NCT04996004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Study of TTI-621 in Combination With Doxorubicin in Patients With Unresectable or Metastatic High-Grade Leiomyosarcoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn about the safety and effects of the study medicine (called Ontorpacept or TTI-621) when given alone and when given in combination with doxorubicin for people with leiomyosarcoma. Leiomyosarcoma is a tumor of the smooth muscles. This study is seeking participants who have: * leiomyosarcoma that is advanced or has spread to other parts of the body (metastatic) * not received prior treatment with anthracyclines (a drug commonly used in patients with some kinds of cancer, including leiomyosarcoma) * not received more than one prior treatment for their leiomyosarcoma During the first 18 weeks of this study, participants will receive doxorubicin by IV infusion (given directly into a vein) at the study clinic every 3 weeks for a total of 6 doses. Participants will also receive Ontorpacept (TTI-621) by IV infusion at the study clinic on the same day as doxorubicin and again one week later for the first 18 weeks. After the first 18 weeks, participants will stop receiving doxorubicin but will continue receiving Ontorpacept (TTI-621) as IV infusion every 14 days at the study clinic. They will keep receiving Ontorpacept (TTI-621) until their cancer is no longer responding to treatment. We will examine the experiences of participants receiving Ontorpacept (TTI-621) in combination with doxorubicin in the first 18 weeks and then Ontorpacept (TTI-621) by itself after the doxorubicin is stopped. This will help us determine if the study medicine Ontorpacept (TTI-621) given with doxorubicin and then by itself is safe and effective. Participants will be involved in the study for approximately one year, depending on how their cancer responds to the study treatment. They will have study visits about 12 times in the first 18 weeks (when the study medicine Ontorpacept is given with doxorubicin) and then every two weeks after the doxorubicin is stopped and the study medicine Ontorpacept (TTI-621) is given by itself.
Study identification
- NCT ID
- NCT04996004
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 21, 2021
- Primary completion
- Dec 6, 2023
- Completion
- Dec 6, 2023
- Last update posted
- Dec 10, 2024
2021 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sarcoma Oncology Research Center | Santa Monica | California | 90403 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| MSK Basking Ridge. | Basking Ridge | New Jersey | 07920 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| MSK Monmouth | Middletown | New Jersey | 07748 | — |
| MSK Bergen | Montvale | New Jersey | 07645 | — |
| MSK Commack. | Commack | New York | 11725 | — |
| MSK Westchester | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York | 11101 | — |
| Memorial Sloan Kettering Cancer Center 53rd street. | New York | New York | 10022 | — |
| Memorial Sloan Kettering Cancer Center - Main Campus | New York | New York | 10065 | — |
| Memorial Sloan Kettering Cancer Center 53rd street. | New York | New York | 10065 | — |
| MSK Nassau | Uniondale | New York | 11553 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | — |
| Oregon Health and Science University - Center for Health and Healing 1 (CHH1) | Portland | Oregon | 97239 | — |
| Oregon Health and Science University - Center for Health and Healing 2(CHH2) | Portland | Oregon | 97239 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04996004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04996004 live on ClinicalTrials.gov.