SL03-OHD-105: An Open-Label, Phase 1b Study of SL-172154 (SIRPα-Fc-CD40L) Administered with Either Pegylated Liposomal Doxorubicin or Mirvetuximab Soravtansine in Subjects with Platinum-Resistant Ovarian Cancers

Contact:

NCT Number:

Protocol:

AAAU3147

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this research study is to test the safety and determine the highest tolerable dose of SL-172154 (study drug) that can be given with Pegylated Liposomal Doxorubicin (PLD) or Mirvetuximab Soravtansine (MIRV). Another purpose of this study is to understand if SL-127154 and PLD or MIRV is effective in managing ovarian cancer. The study drug, SL-172154 is an immunotherapy drug. Immunotherapies are treatments that use your body’s own immune (defense) system to help fight cancer. SL-172154 binds to a protein called CD47 on cancer cells and to a protein called CD40 on immune cells. Pegylated liposomal doxorubicin (PLD), also known by the brand names of Doxil or Caelyx, is a medication that can block a certain enzyme that is involved in cell division and growth; this blocking action may kill cancer cells. PLD is an approved medicine used for the treatment of adults with ovarian cancer whose disease has gotten worse or recurred after a platinum-based chemotherapy. This study is also designed to understand how your body reacts to the study drug (absorbs, distributes, breaks down and gets rid of SL- 172154) and the effect of the combination treatment, if any, on ovarian cancer. The study will examine biomarkers (present in your blood sample or tumor biopsy) that may be related to how the study drug is working. This is the fourth study using SL-172154 in humans. As of 23 April 2022, 28 patients with cancer involving solid tumors have been treated with SL-172154 on its own.

Are you Eligible? (Inclusion Criteria)

  • diagnosed with ovarian, fallopian tube or primary peritoneal cancer that has worsened after within 3-6 months completing platinum containing treatment. 2. must have tissue available from previous surgery. 3. at least one measurable lesion on scans.

Specialty Area(s)

Gynecologic Cancers, Ovarian Cancer, Immunotherapy

Principal Investigator

Profile Headshot
  • Co-Director, Hereditary Breast and Ovarian Cancer Program
  • Director of Clinical Operation, Gyn Oncology

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032