← Back to Search

Anti-tumor antibiotic

ALX148 + Chemotherapy + Immunotherapy for Ovarian Cancer

Phase 2
Recruiting
Led By Haider Mahdi, MD
Research Sponsored by Haider Mahdi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have recurrent epithelial ovarian cancer.
Known BRCA status or willing to be tested.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years (cohort); at 12 weeks (patient)
Awards & highlights

Study Summary

This trial is testing a new immunotherapy that may be more effective and have fewer side effects than current treatments.

Who is the study for?
This trial is for women over 18 with recurrent epithelial ovarian cancer that's resistant to platinum-based therapy. They must have had fewer than six prior treatments, an ECOG performance status of 0-1, and measurable disease. Participants need normal organ/marrow function, known BRCA status, and agree to contraception if applicable.Check my eligibility
What is being tested?
The trial tests ALX148 combined with liposomal doxorubicin and pembrolizumab in patients with ovarian cancer who've shown resistance to platinum therapies. It aims to enhance the effectiveness of immunotherapy by targeting CD47 on tumor cells.See study design
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in various organs (colitis or pneumonitis), infusion reactions from the drugs being administered, fatigue, blood disorders, increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ovarian cancer has come back.
Select...
I know my BRCA gene status or am willing to get tested.
Select...
I have had up to 3 treatments for cancer that did not respond to platinum-based therapy.
Select...
I have had up to 5 previous treatments for my condition.
Select...
I am a woman over 18 years old.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is one of the specified types, like high grade serous or clear cells.
Select...
My cancer came back within 6 months after platinum-based treatment, but it wasn't initially resistant.
Select...
My organ and bone marrow functions are normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years (cohort); at 12 weeks (patient)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years (cohort); at 12 weeks (patient) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Objective response rate Immune-related Response Criteria (iRECIST)
Overall Survival (OS)
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: ALX148 + Doxorubicin (PLD) + PembrolizumabExperimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Doxorubicin
2012
Completed Phase 3
~7940

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,957 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,569 Patients Enrolled for Ovarian Cancer
Haider MahdiLead Sponsor
5 Previous Clinical Trials
162 Total Patients Enrolled
3 Trials studying Ovarian Cancer
92 Patients Enrolled for Ovarian Cancer
ALX OncologyUNKNOWN

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05467670 — Phase 2
Ovarian Cancer Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT05467670 — Phase 2
Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467670 — Phase 2
Ovarian Cancer Research Study Groups: ALX148 + Doxorubicin (PLD) + Pembrolizumab

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patient slots available for this research endeavor?

"The information on clinicaltrials.gov confirms that this particular trial is not looking for new candidates at the moment; it was initially posted in August 2022, with its most recent update occurring two weeks ago. Nevertheless, there are 677 other studies actively recruiting patients across the globe right now."

Answered by AI

Has Pembrolizumab been officially sanctioned by the Food and Drug Administration?

"While the efficacy of pembrolizumab has yet to be established, there is evidence that it can provide a modicum of safety. As such, Power assigned it a score of 2 on its scale from 1-3."

Answered by AI
~16 spots leftby Sep 2025