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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Alexander B Olawaiye, MD
Study ID
NCT05467670
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    A type of immunotherapy that stimulates the body's immune system to fight cancer cells by targeting and blocking PD-1 proteins on the surface of certain immune T-cells, thus triggering the T-cells to find and kill cancer cells.
  • ALX148 — DRUG
    A fusion protein comprised of a high affinity CD47 blocker linked to an inactive immunoglobulin Fc region, enhancing innate and adaptive immune responses against cancer.
  • Doxorubicin — DRUG
    An anthracycline that slows/stops the growth of cancer cells by blocking an enzyme called topo isomerase 2, used as second line non-platinum chemotherapy in patients with platinum-resistant ovarian cancer.

Study Details

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).

Key Dates

Start date
Mar 30, 2023
Status verified
Mar 2026
Primary completion
Apr 22, 2026
Completion
Jan 22, 2031

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ALX148 + Doxorubicin (PLD) + Pembrolizumab
    Given on Day 1 of each 21 day cycle, in the following order of administration: 200 mg IV pembrolizumab\* (maximum of 2 years (approximately 35 cycles) 45 mg/kg IV ALX148 30 mg/m\^2 IV doxorubicin (Pegylated Liposomal Doxorubicin (PLD)\* \*standard of care

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 3 years (cohort) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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