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Experimental drug combo targets tough bone cancer

NCT ID NCT04833582

Disease control Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new drug called azenosertib (ZN-c3) combined with the chemotherapy gemcitabine in 31 people aged 12 and older with osteosarcoma that had relapsed or stopped responding to treatment. The goal was to see if the combination is safe and whether it can slow or stop tumor growth. The study is now complete, and results will help decide if further testing is warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Azenosertib (ZN-c3) combined with gemcitabine
What this could lead to
If it works, this could offer a new treatment option for people with osteosarcoma that has come back or not responded to standard therapy.
What could go wrong
This is an early phase 1/2 trial with only 31 participants, so results are preliminary. The combination may cause significant side effects and may not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Aug 2021

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 12 years at the time of informed consent * Bodyweight ≥ 40 kg * Histologically documented relapsed or metastatic osteosarcoma. * Must have measurable disease according to RECIST Guideline version 1.1 criteria. * Adequate hematologic and organ function. * Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation. * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: * Unresolved toxicity of Grade \>1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation) * Prior therapy with a WEE1 inhibitor * A serious illness or medical condition(s). * Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test \<14 days to Day 1. * Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. * 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. * History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP). * Taking medications with a known risk of TdP. * Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.

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Conditions

The condition(s) this trial relates to.

osteosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteosarcoma

Contacts and locations

Locations

  • Site 0103

    Houston, Texas, 77030, United States

  • Site 0105

    New York, New York, 10065, United States

  • Site 0106

    Los Angeles, California, 90095, United States

  • Site 0107

    Cincinnati, Ohio, 45229, United States

  • Site 0122

    Seattle, Washington, 98195, United States

  • Site 0123

    Portland, Oregon, 97239, United States

  • Site 0124

    Oakland, California, 94609, United States

  • Site 0188

    Richmond, Virginia, 23298, United States

  • Site 0193

    Memphis, Tennessee, 38105, United States

  • Site 0195

    Santa Monica, California, 90403, United States

  • Site 0197

    Nashville, Tennessee, 37332, United States

  • Site 3601

    Lyon, 69008, France

  • Site 3602

    Marseille, 13385, France

  • Site 3604

    Bordeaux, 33000, France

  • Site 3605

    Toulouse, 31100, France

  • Site 3606

    Paris, 75248, France

  • University of Florida College of Medicine

    Gainesville, Florida, 32610, United States

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