Study on Axatilimab, Retifanlimab, and Paclitaxel for Treating Advanced or Metastatic Solid Tumors

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06320405

Provider View

This clinical trial is testing a new combination of drugs—axatilimab, retifanlimab, and paclitaxel—to see if they are safe and effective in treating patients with advanced or metastatic solid tumors. These tumors have either spread to nearby tissues or to other parts of the body.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with advanced or metastatic solid tumors, which are cancers that have spread from their original site. The treatment combines three drugs: axatilimab, retifanlimab, and paclitaxel. Axatilimab and retifanlimab are types of immunotherapy that may help the immune system attack cancer cells, while paclitaxel is a chemotherapy drug that stops cancer cells from growing. The study aims to determine if this combination is safe and effective in shrinking tumors.

Description

The study is divided into two phases. In Phase I, researchers will assess the safety and tolerability of the drug combination in patients with advanced solid tumors. In Phase II, they will evaluate how effective the treatment is in reducing tumor size.

Participants will receive axatilimab through an IV on specific days of each treatment cycle, which lasts 28 days. Retifanlimab and paclitaxel will also be given through an IV on scheduled days. The treatment cycles will continue as long as the cancer does not progress and side effects are manageable.

Throughout the study, participants will undergo various tests, including tumor biopsies, CT scans, and blood tests, to monitor their response to the treatment. After completing the study treatment, follow-up visits will occur at 30 and 90 days to check on the patients' health and any lasting effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and provide written consent.
  • Be 18 years or older.
  • Have a confirmed diagnosis of metastatic solid tumor.
  • Have at least one measurable tumor and another that can be biopsied.
  • Have tried standard treatments without success or a clinical trial is considered the best option.
  • Have not received investigational therapy within a specified time before the study.
  • Have previously been treated with taxanes, with a wash-out period of at least 3 months.
  • Have an ECOG performance status of 0 or 1, indicating good overall health.
  • Have a life expectancy of more than 12 weeks.
  • Meet specific blood count and organ function criteria.
  • Be willing to adjust medications as needed and use effective contraception if of childbearing potential.

Exclusion Criteria

  • Have had another cancer diagnosed within the last 3 years.
  • Have new or worsening brain metastases unless stable for at least 4 weeks.
  • Have received palliative radiation therapy within 1 week before the study.
  • Have had a live vaccine within 28 days before the study.
  • Have a history of organ transplantation.
  • Have lung disease or active pneumonia.
  • Have an active autoimmune disease requiring high doses of steroids.
  • Have unresolved side effects from previous cancer treatments.
  • Have allergies to any of the study drugs.
  • Have an active infection requiring antibiotics.
  • Be pregnant or breastfeeding, or not willing to use contraception if of childbearing potential.
  • Have any uncontrolled illness or psychiatric condition that would interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.