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NCT06320405 · ClinicalTrials.gov registry record · Phase 1

Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors

A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by OHSU Knight Cancer Institute.

Recruiting
Registry status
Phase 1
Development phase
38
Enrollment target
1
Study location

NCT06320405: Recruiting Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by OHSU Knight Cancer Institute.

NCT06320405 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is actively recruiting participants, run by OHSU Knight Cancer Institute. The registered enrollment target is 38 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06320405, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is actively recruiting participants, sponsored by OHSU Knight Cancer Institute.

RECRUITING
Registry status
Phase 1
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors.

Primary Outcome

Will be coded by system organ class, MedDRA preferred term, and severity grade using Common Terminology Criteria for Adverse Events (version 5.0).

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Axatilimab

Study Locations (1)

Oregon

  • OHSU Knight Cancer Institute - Portland

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2024-05-21
Est. Completion 2029-04-01
Phase Phase 1
OHSU Knight Cancer Institute

211 total trials

What NCT06320405 shows while recruiting

NCT06320405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (78% lower).

The record links to 4 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06320405 reports a single indexed study location in Oregon.

Frequently Asked Questions

What is clinical trial NCT06320405 about?

NCT06320405 is a clinical study titled "Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors". This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advance...

What is the current status of trial NCT06320405?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2024-05-21. Estimated completion is 2029-04-01.

What conditions does trial NCT06320405 study?

This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm.

What interventions are being tested in trial NCT06320405?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Axatilimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT06320405?

This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06320405 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Malignant Solid Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06320405's enrollment target sits among peer trials

38 66th of 108 higher than 42 of 108 other Advanced Malignant Solid Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06320405, the US trial registry maintained by the National Library of Medicine. NCT06320405 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.