A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With Leiomyosarcoma
NCT ID: NCT04996004
Last Updated: 2024-12-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
76 participants
INTERVENTIONAL
2021-06-22
2023-12-07
Brief Summary
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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.
Detailed Description
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Phase I will enroll patients with soft-tissue sarcomas including leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma or epithelioid sarcoma to evaluate escalating doses of Ontorpacept (TTI-621) administered in combination with fixed-dose doxorubicin for up to six cycles followed by Ontorpacept (TTI-621) monotherapy.
Phase II will enroll patients with high-grade leiomyosarcoma and will evaluate two dose levels of Ontorpacept (TTI-621) in combination with fixed-dose doxorubicin for up to six cycles followed by Ontorpacept (TTI-621) monotherapy.
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation (Ontorpacept+doxorubicin)
In the dose escalation portion of the study, participants with specific subsets of soft tissue sarcomas who have not received more than one prior line of therapy and have not received an anthracycline in any setting will be enrolled in three escalating dose cohorts to characterize the safety and tolerability of Ontorpacept (TTI-621) when administered in combination with doxorubicin for up to six cycles and followed by Ontorpacept (TTI-621) monotherapy
Ontorpacept (TTI-621)
Ontorpacept (TTI-621) will be administered by intravenous infusion.
Doxorubicin
75 mg/m\^2 by intravenous infusion in 21-day cycles for a maximum of six cycles.
Dose Expansion Dose Level A (Cohort A)
Participants with high-grade leiomyosarcoma will receive up to six cycles of Ontorpacept (TTI-621) at a pre-specified dose level (Dose Level A) in combination with fixed-dose doxorubicin followed by Ontorpacept (TTI-621) monotherapy to further characterize safety, tolerability, and clinical activity of the treatment regimen.
Ontorpacept (TTI-621)
Ontorpacept (TTI-621) will be administered by intravenous infusion.
Doxorubicin
75 mg/m\^2 by intravenous infusion in 21-day cycles for a maximum of six cycles.
Dose Expansion Dose Level B (Cohort B)
Participants with high-grade leiomyosarcoma will receive up to six cycles of Ontorpacept (TTI-621) at a pre-specified dose level (Dose Level B) in combination with fixed-dose doxorubicin followed by Ontorpacept (TTI-621) monotherapy to further characterize safety, tolerability, and clinical activity of the treatment regimen.
Ontorpacept (TTI-621)
Ontorpacept (TTI-621) will be administered by intravenous infusion.
Doxorubicin
75 mg/m\^2 by intravenous infusion in 21-day cycles for a maximum of six cycles.
Dose Expansion Dose Level C (Cohort C)
Participants with high-grade leiomyosarcoma will receive up to six cycles of Ontorpacept (TTI-621) at a pre-specified dose level (Dose Level C) in combination with fixed-dose doxorubicin followed by Ontorpacept (TTI-621) monotherapy to further characterize safety, tolerability, and clinical activity of the treatment regimen.
Ontorpacept (TTI-621)
Ontorpacept (TTI-621) will be administered by intravenous infusion.
Doxorubicin
75 mg/m\^2 by intravenous infusion in 21-day cycles for a maximum of six cycles.
Interventions
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Ontorpacept (TTI-621)
Ontorpacept (TTI-621) will be administered by intravenous infusion.
Doxorubicin
75 mg/m\^2 by intravenous infusion in 21-day cycles for a maximum of six cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically-confirmed high-grade soft tissue sarcoma that is metastatic or locally advanced and not amenable to curative treatment with surgery or radiation.
1. In the Dose Escalation phase, indications will be limited to high-grade leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma
2. In the Dose Expansion phase, indications will be limited to high-grade leiomyosarcoma.
3. Objective evidence of disease progression unless disease is newly-diagnosed.
4. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (expansion cohorts).
5. Adequate organ and hematologic function.
6. No more than 1 prior treatment regimen for advanced disease, which is limited to gemcitabine with docetaxel.
7. Anthracycline-naïve.
8. Patients who were treated with a prior chemotherapy regimen must have completed treatment at least three weeks before initiation of study treatment.
9. All adverse events from prior treatment must be NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5 Grade ≤ 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.
10. Radiotherapy, including palliative radiotherapy, completed at least two weeks prior to treatment; palliative radiation to non-target lesions while on study is allowed.
Exclusion Criteria
2. History of or current Class II, III, or IV heart failure.
3. History or evidence of known CNS (central nervous system) metastases or carcinomatous meningitis.
4. Significant bleeding disorders, vasculitis or a significant bleeding episode from the GI (gastrointestinal) tract.
5. History of severe hypersensitivity reactions to antibodies.
6. Systemic steroid therapy.
7. History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs.
8. Prior organ transplantation including allogenic or autologous stem cell transplantation
9. Prior treatment with anti-CD47 (Cluster of Differentiation 47) or anti-signal regulatory protein alpha (SIRPα) therapy.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Sarcoma Oncology Research Center
Santa Monica, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
MSK Basking Ridge.
Basking Ridge, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
MSK Monmouth
Middletown, New Jersey, United States
MSK Bergen
Montvale, New Jersey, United States
MSK Commack.
Commack, New York, United States
MSK Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York, United States
MSK Nassau
Uniondale, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Oregon Health and Science University - Center for Health and Healing 1 (CHH1)
Portland, Oregon, United States
Oregon Health and Science University - Center for Health and Healing 2(CHH2)
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4961003
Identifier Type: OTHER
Identifier Source: secondary_id
TTI-621-03
Identifier Type: -
Identifier Source: org_study_id