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Monoclonal Antibodies

Axatilimab + Retifanlimab + Paclitaxel for Cancer

Phase 1 & 2

Recruiting

Led By Shivaani Kummar

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening to end of treatment visit (an average of 6 months)

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a combination of three drugs - axatilimab, retifanlimab, and paclitaxel - for treating patients with advanced or metastatic solid tumors.

Who is the study for?

This trial is for patients with advanced or metastatic solid tumors. Participants should have a tumor that has spread from its original site to other body parts. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

What is being tested?

The trial is testing the combination of axatilimab, retifanlimab (both monoclonal antibodies), and paclitaxel (a chemotherapy drug) on patients with solid tumors. It aims to see if this mix can safely and effectively stop cancer growth by helping the immune system attack the cancer cells.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's enhancement such as inflammation in various organs, infusion-related reactions due to antibody administration, fatigue from treatment burden, digestive issues caused by chemotherapy drugs like paclitaxel, and an increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening to end of treatment visit (an average of 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening to end of treatment visit (an average of 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to end of treatment visit (an average of 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical benefit rate (phase Ib/II)

Incidence of dose limiting toxicities (phase Ib)

Secondary study objectives

Change in immune cell population

Changes in immune cell composition and functionality

Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (axatilimab, retifanlimab, paclitaxel)Experimental Treatment8 Interventions

Patients receive axatilimab IV over 30 minutes on day -8, prior to cycle 1. Beginning in cycle 1 day 1, patients receive axatilimab IV over 30 minutes on days 8 and 21 of each cycle, retifanlimab IV over 30-60 minutes on day 1 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy, CT scan, and blood sample collection throughout the study and may undergo MRI and/or PET scan throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790