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Monoclonal Antibodies
SL-172154 Combination Therapy for Ovarian Cancer
Phase 1
Waitlist Available
Research Sponsored by Shattuck Labs, 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 first dose up to 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, SL-172154, to see if it is safe and effective when used with other drugs to treat ovarian cancer.
Who is the study for?
This trial is for adults with high-grade ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based chemotherapy. Participants must have measurable disease and be in good physical condition (ECOG PS of 0 or 1). They should not have had certain prior treatments like anti-CD47 agents and must have recovered from previous therapy side effects. Those with active infections, other cancers needing treatment, severe heart conditions, or immune diseases are excluded.Check my eligibility
What is being tested?
The study tests SL-172154 combined with either pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients whose ovarian cancer doesn't respond to platinum drugs. The trial has two parts: finding the right dose and then seeing how well it works on a larger group.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in organs, infusion-related symptoms like fever or chills, fatigue, digestive issues including nausea and diarrhea, blood disorders which can affect cell counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with MIRV
Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with PLD
Evaluate safety and tolerability of SL-172154 when administered with MIRV
+1 moreSecondary outcome measures
Area under the serum concentration-time curve (AUC) of DM4 Payload
Area under the serum concentration-time curve (AUC) of MIRV
Area under the serum concentration-time curve (AUC) of S-Methyl DM4 Payload
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)Experimental Treatment1 Intervention
Pegylated Liposomal Doxorubicin (PLD) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration.
Group II: Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)Experimental Treatment1 Intervention
Mirvetuximab (MIRV) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration
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Who is running the clinical trial?
Shattuck Labs, Inc.Lead Sponsor
4 Previous Clinical Trials
286 Total Patients Enrolled
1 Trials studying Ovarian Cancer
34 Patients Enrolled for Ovarian Cancer
Shattuck LabsStudy DirectorShattuck Labs
4 Previous Clinical Trials
286 Total Patients Enrolled
1 Trials studying Ovarian Cancer
34 Patients Enrolled for Ovarian Cancer
Fatima Rangwala, MD, PhDStudy DirectorShattuck Labs
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have previously been treated with doxorubicin or PLD.I have been diagnosed with a specific type of advanced ovarian cancer.I have been diagnosed with a non-infectious lung condition.I am not currently on any cancer treatments like chemotherapy or immunotherapy.I do not have another cancer that needs treatment which would affect this study's monitoring.I haven't taken any immune-weakening drugs in the last week.I have previously been treated with MIRV or a similar drug.I have not had any cancer treatment within the specified time before joining.My organs are functioning well and my blood counts are normal.I agree to provide a sample of my tumor for testing.I haven't received any live vaccines in the last 28 days.I have had a stem cell or organ transplant from another person.I am 18 years old or older.I have a severe liver condition (Child-Pugh Class B or C).My cancer did not respond to platinum-based chemotherapy.I do not have serious or unmanaged heart problems.I have had 1 to 3 treatments for cancer.I have ongoing eye problems like glaucoma, macular degeneration, or have had a corneal transplant.I have ovarian cancer and received no more than one treatment for platinum-resistant disease.I had one platinum-based treatment, responded to it, and my cancer progressed 3-6 months after the last dose.I agree to have 2 tumor biopsies for the study, unless it's too risky.I have severe stomach or intestinal problems.I am taking folate supplements.I haven't taken antibiotics for an infection in the last 5 days.I have recovered from side effects of previous cancer treatments.My tumor is positive for a specific protein, as confirmed by a special test.My cancer has not spread to my brain or its coverings.I have an autoimmune disease but it's not diabetes, vitiligo, alopecia, or thyroid issues.My cancer got worse within 6 months after my last platinum therapy, but I didn't get worse during or right after the first treatment.I have not been treated with drugs targeting SIRPα, CD47, or CD40 before.I have high grade serous ovarian, peritoneal, or fallopian tube cancer.My cancer worsened within 6 months after my last platinum therapy.My cancer did not improve or worsened within 3 months after starting platinum-based chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)
- Group 2: Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)
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.
Has the combination of Mirvetuximab and SL-172154 been authorized by the FDA?
"Our internal risk rating for Mirvetuximab + SL-172154 is 1 due to it being a Phase 1 trial, which implies limited data has been collected on its safety and efficacy."
Answered by AI
What are the foremost objectives of this medical experiment?
"In this study, the primary outcome measured between first dose up to one year is assessing the safety and acceptability of SL-172154 when combined with PLD. Additionally, secondary objectives are observing the terminal elimination half-life (t1/2) of MIRV, calculating area under serum concentration time curve (AUC) for total antibody after single and multiple doses, as well as determining its associated terminal elimination half-life (t1/2)."
Answered by AI
Is enrollment for this clinical trial still taking place?
"Clinicaltrials.gov denotes that this medical trial is currently enrolling participants, with its inception on August 18th 2022 and the latest update taking place on November 15th of the same year."
Answered by AI
In which locales is this experiment involving human subjects taking place?
"The Sarah Cannon Research Institute, City of Hope in Duarte and START Midwest are the three primary clinical trial sites. Additionally, 4 other locations have been enlisted to assist with this project."
Answered by AI
How many participants are eligible to take part in this clinical trial?
"Affirmative. According to the records of clinicaltrials.gov, this medical study has been open for recruitment since August 18th 2022 and was last amended on November 15th 2022. At the moment, 102 participants are required from 4 different sites."
Answered by AI
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