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Anti-tumor antibiotic
Ontorpacept + Doxorubicin for Leiomyosarcoma (TTI-621-03 Trial)
Phase 2
Waitlist Available
Research Sponsored by Trillium Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of treatment until discontinuation from study (up to approximately 29 months)
Awards & highlights
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.
Who is the study for?
This trial is for people with advanced leiomyosarcoma, a type of muscle tumor, who haven't been treated with anthracyclines and have had at most one other treatment. Participants should be in good overall health with no severe allergies to antibodies or history of certain autoimmune diseases or organ transplants.Check my eligibility
What is being tested?
The study tests Ontorpacept (TTI-621) alone and combined with Doxorubicin in treating leiomyosarcoma. Initially, both drugs are given by IV every three weeks for 18 weeks; afterwards, only Ontorpacept is continued biweekly until it's not effective anymore.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system due to antibody therapy, potential heart issues from Doxorubicin, and general risks like fatigue and nausea associated with chemotherapy treatments.
TTI-621-03 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of treatment until discontinuation from study (up to approximately 29 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of treatment until discontinuation from study (up to approximately 29 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean and changes from baseline in blood pressure
Percentage of patients with objective response
Secondary outcome measures
Categorical summary of ECG parameters
Disease control rate (DCR)
Duration of disease control (DDC)
+12 moreTTI-621-03 Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Expansion Dose Level C (Cohort C)Experimental Treatment2 Interventions
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.
Group II: Dose Expansion Dose Level B (Cohort B)Experimental Treatment2 Interventions
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.
Group III: Dose Expansion Dose Level A (Cohort A)Experimental Treatment2 Interventions
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.
Group IV: Dose Escalation (Ontorpacept+doxorubicin)Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
Trillium Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
528 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,798 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
48 Patients Enrolled for Leiomyosarcoma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,966 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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)."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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"
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
How old are they?
18 - 65
What site did they apply to?
Cancer Center of Southern California
Moffitt Cancer Center
Sarcoma Oncology Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am still learning about my condition. I am newly diagnosed with grade 3 in my thigh extending into the dermis. I want to explore options for next steps as my sarcoma has a very high growth rate. Almost visually larger ever day. Whatever it takes to help me and others to overcome this disease.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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