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Ontorpacept + Doxorubicin for Leiomyosarcoma (TTI-621-03 Trial)
TTI-621-03 Trial Summary
This trial is testing a new drug, TTI-621, for patients with leiomyosarcoma that cannot be removed by surgery or has spread to other parts of the body.
TTI-621-03 Trial Timeline
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Outcome measures can provide a clearer picture of what you can expect from a treatment.TTI-621-03 Trial Design
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- You have not received anthracycline chemotherapy before.The Eastern Cooperative Oncology Group (ECOG) defines a performance status of 0 or 1 as "fully active, able to carry out all usual activities.You have finished radiotherapy treatment at least two weeks ago, but radiation to non-target areas for symptom relief is still allowed during the study.The study evaluated the efficacy and safety of osimertinib in patients with measurable disease per RECIST v1.1 who had not received previous treatment with an EGFR inhibitor.The study is looking for participants with certain types of high-grade sarcomas such as leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma in the Dose Escalation phase. In the Dose Expansion phase, the study is only looking for participants with high-grade leiomyosarcoma.You have received treatment with a specific type of medication called anti-CD47 or anti-SIRPα therapy before.You have a history of serious heart problems.You have or have had serious heart problems that affect how well your heart pumps blood.You have a serious bleeding disorder, inflammation of blood vessels, or a major bleeding episode from the digestive system.You have a type of cancer called high-grade soft tissue sarcoma that has spread or is in an advanced stage, and cannot be treated with surgery or radiation to be cured.You have experienced severe allergic reactions to antibodies in the past.Only people who have certain types of advanced sarcoma will be included in the first part of the study.Only participants with high-grade leiomyosarcoma will be included in the study during the Dose Expansion phase.You have a history of cancer spreading to your brain or its covering membranes.Your disease is getting worse, unless it is a new diagnosis.You must have finished your previous chemotherapy treatment at least three weeks before starting the study treatment.You have finished any radiotherapy treatment at least two weeks before starting this study. However, if you need palliative radiation for non-target areas during the study, that is still allowed.Only people with high-grade leiomyosarcoma will be considered for the study during the Dose Expansion phase.
- Group 1: Dose Expansion Dose Level B (Cohort B)
- Group 2: Dose Expansion Dose Level A (Cohort A)
- Group 3: Dose Expansion Dose Level C (Cohort C)
- Group 4: Dose Escalation (Ontorpacept+doxorubicin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are some of the conditions that TTI-621 has been approved to treat?
"TTI-621 is an effective cancer treatment for patients affected by lymphoma, hodgkins, carcinoma, bronchogenic, and neuroblastoma (nb)."
How many people fit the requirements to participate in this research project?
"The sponsor, Pfizer, needs 80 patients that meet the specified inclusion criteria to start the trial. The trial will be conducted at OHSU in Portland, Oregon and MSK Bergen in Montvale, New jersey."
Are researchers still actively recruiting patients for this clinical trial?
"The clinical trial is recruiting patients and was first posted on 6/22/2021. The most recent update to the posting was on 7/26/2022."
By how many different research teams is this clinical trial being overseen?
"Currently, this clinical trial has 25 patients that are enrolled, with additional locations looking to enroll more. Some of these places include OHSU in Portland, MSK Bergen in Montvale, and the Sarcoma Oncology Research Center in Commack."
Have there been similar investigations to this one in the past?
"TTI-621 is being used in 381 active clinical trials, across 67 countries and 1935 cities. The first ever trial for TTI-621 was completed in 1997 by Alfacell. That study had 300 participants and reached Phase 3 approval. In the 24 years since that initial study, 679 more have been completed."
What is the official stance of the FDA on TTI-621?
"TTI-621 falls into the realm of Phase 2 trials, meaning that while there is evidence suggesting it is safe, there are no studies attesting to its efficacy. We scored it a 2."
Does TTI-621 have a history of being investigated in other research?
"TTI-621 was first researched in 1997 at Spectrum Health Hospital - Butterworth Campus. There have been a total of 679 studies completed as of now, with 381 clinical trials still active. A large portion of these are being conducted in Portland, Oregon."
By what standards will success be measured for this research project?
"The primary outcome of this clinical trial, which will be measured over a time frame of months 6 to 32, is to Phase II: Characterize the safety of selected dose levels of TTI-621 in combination with doxorubicin: frequency of adverse events. Secondary outcomes include Phase II: Characterize antitumor activity of TTI-621: disease control rate which is defined as Characterize disease control rate (DCR [CR + PR + SD]) as defined by RECIST v1.1 criteria., Phase II: Characterize antitumor activity of TTI-621: progression-free survival"
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