New pill JAB-3312 tested in patients with advanced cancers

NCT ID NCT04045496

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an oral drug called JAB-3312 in 40 adults with advanced solid tumors (like lung, colon, or breast cancer) that had stopped responding to standard treatments. The main goals were to find a safe dose and check for side effects. Researchers also looked for any signs that the drug might slow tumor growth.

What this could mean

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

Active substance
JAB-3312 (an oral drug taken as capsules)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 40 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.

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

40 people

The number who actually took part.

Started

Sep 2019

Finished

Dec 2022

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

18 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: 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. 4. Subjects with life expectancy ≥3 months. 5. Patients must have at least one measurable lesion as defined by RECIST v1.1. 6. Patients who have sufficient baseline organ function. Exclusion Criteria: 1. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent). 2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases. 3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain. 4. 8\. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 5. History or evidence of active infections (Grade ≥2). 6. History or evidence of significant inflammatory or vascular eye disorder. 7. History of an allogeneic bone marrow or solid organ transplant. 8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312. 9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312. 10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment. 11. Subjects experiencing unresolved Grade \>1 toxicity before the start of treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • HealthONE Clinic Services Oncology-Hematology

    Denver, Colorado, 80202, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Washington University School of Medicine

    Seattle, Washington, 63110, United States

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