Active — Not RecruitingPhase 2

Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer

United States16 participantsStarted 2023-03-30

Plain-language summary

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Participants must have recurrent epithelial ovarian cancer.

Exclusion criteria

✕. Following histology types are acceptable: high grade serous or high grade endometrioid, clear cells, high grade translational cell, poorly differentiated or undifferentiated carcinomas, mixed histology (including one of above histology).
✕. 0-3 prior lines in platinum-resistant setting.
✕. Known BRCA status or willing to be tested.
✕. Up to 5 prior lines of therapy are allowed.
✕. Participants must have measurable disease based on RECIST 1.1 with at least one target lesion.
✕. Participants must have an ECOG performance status of 0-1.
✕. Participants must be female, Age \>18 years. Because no dosing or AE data are currently available on the use of pembrolizumab in combination with ALX148 in participants ≤18 years of age, children are excluded from this study.
✕0. Participants must have normal organ and marrow function as defined below within 14 days of enrollment unless otherwise indicated.

What they're measuring

Objective Response Rate (ORR)

Timeframe: Up to 3 years (cohort)

Trial details

NCT IDNCT05467670

SponsorAlexander B Olawaiye, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-22

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