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New cancer pill tested in early trial – but study halted

NCT ID NCT06232408

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested an oral drug called RP-1664 in people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to find a safe dose and check for side effects. The study was terminated early, so full results may not be available.

What this could mean

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

Active substance
RP-1664 (an oral PLK4 inhibitor)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This was a very early Phase 1 trial with only 29 participants, and it was terminated, so results may not be available. The drug may not prove effective or safe in larger studies.

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

29 people

The number who actually took part.

Started

Feb 2024

Finished

Aug 2025

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 to 100 years

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: * Written informed consent or assent, according to local guidelines, signed and dated by the patient or legal guardian prior to the performance of any study-specific procedures, sampling, or analyses. * Male or female and ≥ 12 years-of-age at the time of signature of the consent or assent, and are at least 6th grade reading level to consent; participants \< 18 years of age must weigh at least 40 kg. * Life expectancy ≥ 4 months. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Locally advanced or metastatic solid tumor that has progressed or was nonresponsive or intolerant to available therapies and for which no standard or available curative therapy exists. * Measurable disease as per RECIST v1.1 or INRC. * Existing biomarker profile (tumor tissue or plasma) reported from a local test obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarkers. * Available tumor tissue. * Molecularly eligible tumor profile from a CLIA-certified pathology report. * Ability to comply with the protocol and study procedures detailed in the Schedule of Assessments. * Ability to swallow and retain oral medications. * Acceptable organ function at screening. * Acceptable blood counts at screening. * Negative pregnancy test (serum or urine) for females of childbearing potential at Screening and while on study drug. * Resolution of all toxicities of prior treatment or surgery. * Use of highly effective forms of contraception. Exclusion Criteria: * History or current condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment. * Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the patient's safety. * Uncontrolled, symptomatic brain metastases. * Presence of other known second malignancy with the exception of any cancer that has been in complete remission for ≥ 2 years or completely resected squamous and basal cell carcinomas of the skin. * Patients with active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. * Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, active or within 6 months prior to enrollment. * Moderate or severe hepatic impairment (ie, Child-Pugh class B or C). * Uncontrolled high blood pressure. * Chemotherapy, small molecule or biologic antineoplastic agent given within 21 days. * Previously prescribed receptor activator of nuclear factor kappa B ligand (RANKL) inhibitor initiated less than 4 months prior to trial entry. Bisphosphonates are allowed if initiated/administered at least 28 days prior to enrollment. * I-131 Meta-Iodo-Benzyl-Guanidine (MIGB) therapy within 6 weeks prior to initiation of trial treatment. * Prior treatment with a PLK4 inhibitor. * Current treatment with medications that are known to prolong the QT interval.

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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

  • Participating Site 1004

    New York, New York, 10065, United States

  • Participating Site 1008

    New York, New York, 10032, United States

  • Participating Site 1012

    New Haven, Connecticut, 06519, United States

  • Participating Site 1025

    San Francisco, California, 94143, United States

  • Participating Site 4001

    Copenhagen, Denmark

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