Mirvetuximab + SL-172154 for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute, Nashville, TN
Carcinoma+12 More
Mirvetuximab + SL-172154 - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study in two phases: dose escalation and dose expansion.

Eligible Conditions

  • Fallopian Tubes Cancer
  • Carcinoma
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Platinum-resistant Ovarian Cancer (PROC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma

Study Objectives

4 Primary · 19 Secondary · Reporting Duration: first dose up to 3 years

Year 1
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
Year 3
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
Area under the serum concentration-time curve (AUC) of SL-172154
Area under the serum concentration-time curve (AUC) of Total Antibody
Evaluate safety and tolerability of SL-172154 when administered with MIRV
Evaluate safety and tolerability of SL-172154 when administered with PLD
Immunogenicity to MIRV
Immunogenicity to SL-172154
Maximum serum concentration (Cmax) of DM4 Payload
Maximum serum concentration (Cmax) of MIRV
Maximum serum concentration (Cmax) of S-Methyl DM4 Payload
Maximum serum concentration (Cmax) of SL-172154
Maximum serum concentration (Cmax) of Total Antibody
Terminal elimination half-life (t1/2) of DM4 Payload
Terminal elimination half-life (t1/2) of MIRV
Terminal elimination half-life (t1/2) of S-Methyl DM4 Payload
Terminal elimination half-life (t1/2) of SL-172154
Terminal elimination half-life (t1/2) of Total Antibody
To assess preliminary evidence of anti-tumor activity of SL-172154 when administered with MIRV
To assess preliminary evidence of anti-tumor activity of SL-172154 when administered with PLD

Trial Safety

Safety Progress

1 of 3

Other trials for Carcinoma

Trial Design

2 Treatment Groups

Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)
1 of 2
Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)
1 of 2
Experimental Treatment

102 Total Participants · 2 Treatment Groups

Primary Treatment: Mirvetuximab + SL-172154 · No Placebo Group · Phase 1

Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)
Drug
Experimental Group · 1 Intervention: Mirvetuximab + SL-172154 · Intervention Types: Drug
Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)
Drug
Experimental Group · 1 Intervention: Pegylated Liposomal Doxorubicin + SL-172154 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first dose up to 3 years
Closest Location: Sarah Cannon Research Institute · Nashville, TN
Photo of sarah cannon research institute 1Photo of sarah cannon research institute 2Photo of sarah cannon research institute 3
2004First Recorded Clinical Trial
23 TrialsResearching Carcinoma
247 CompletedClinical Trials

Who is running the clinical trial?

Shattuck Labs, Inc.Lead Sponsor
4 Previous Clinical Trials
239 Total Patients Enrolled
2 Trials studying Carcinoma
92 Patients Enrolled for Carcinoma
Fatima Rangwala, MD, PhDStudy DirectorShattuck Labs

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have given informed consent to participate in the study.
You have a histologically confirmed diagnosis of high grade serous EOC, primary peritoneal cancer, or fallopian tube cancer
Subjects who have received platinum-based therapy must have had a complete response/remission (CR) or partial response/remission (PR) and then progressed between >3 months and ≤6 months after the date of the last dose of platinum.
Subjects who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum.
Patients who are platinum refractory during front-line treatment are excluded.
Subjects must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab or be medically-ineligible for bevacizumab.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.