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Monoclonal Antibodies

Combination of Mirvetuximab + SL-172154 and Combination of Pegylated Liposomal Doxorubicin + SL-172154 for Ovarian Cancer

Phase 1
Recruiting
Research Sponsored by Shattuck Labs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Patients who are platinum refractory during front-line treatment are excluded [primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy]
[PLD Cohort] Subject has a histologically confirmed diagnosis of high grade EOC, primary peritoneal cancer, or fallopian tube cancer. Non-epithelial tumors and ovarian tumors with low malignant potential are excluded.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfirst dose up to 3 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Fallopian Tube Carcinoma
  • Peritoneal Carcinoma
  • Ovarian Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
If you have already received 2 or 3 cycles of platinum therapy, your cancer must have gotten worse within 6 months after your last dose of platinum.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose up to 3 years for reporting.

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 more
Secondary 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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Find a Location

Who is running the clinical trial?

Shattuck Labs, Inc.Lead Sponsor
4 Previous Clinical Trials
233 Total Patients Enrolled
Shattuck LabsStudy DirectorShattuck Labs
4 Previous Clinical Trials
233 Total Patients Enrolled
Fatima Rangwala, MD, PhDStudy DirectorShattuck Labs

Media Library

Mirvetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05483933 — Phase 1
Fallopian Tube Carcinoma Research Study Groups: Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L), Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)
Fallopian Tube Carcinoma Clinical Trial 2023: Mirvetuximab Highlights & Side Effects. Trial Name: NCT05483933 — Phase 1
Mirvetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05483933 — Phase 1

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
Recent research and studies
clinicaltrials.govStudy
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
2022. "Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05483933.
~32 spots leftby Jul 2024
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