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New hope for advanced cancers: experimental drug KQB168 enters human testing

NCT ID NCT06994806

Disease control Sponsor: Kumquat Biosciences Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new oral drug, KQB168, alone or with pembrolizumab, in adults with advanced solid tumors that have stopped responding to immunotherapy. The main goals are to find safe doses and see if the drug can shrink tumors. About 84 participants will take the drug daily and have frequent clinic visits for monitoring.

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

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2028

An estimate. End dates often move.

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: * Histologically confirmed diagnosis of solid tumor malignancy. * Unresectable or metastatic disease that has progressed on immunotherapy. * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 Exclusion Criteria: * Active primary central nervous system tumors * Cardiac abnormalities * History of lung diseases * Any condition that may impair drug absorption or prevent oral dosing * Known history of immune-mediated colitis and uncontrolled autoimmune diseases

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Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

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

Solid tumor malignancies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Florida Cancer Specialists - Sarasota

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Mary Crowley Cancer Research Centers

    RECRUITING

    Dallas, Texas, 75230, United States

  • Mayo Clinic - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - Phoenix

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • NEXT Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Huston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Sarah Cannon Cancer Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT MD Anderson Cancer Center - Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Yale Cancer Center- New Haven

    RECRUITING

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.