New cancer pill tested in early trial – but study halted
NCT ID NCT06232408
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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29 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Aug 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Participating Site 1004
New York, New York, 10065, United States
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Participating Site 1008
New York, New York, 10032, United States
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Participating Site 1012
New Haven, Connecticut, 06519, United States
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Participating Site 1025
San Francisco, California, 94143, United States
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Participating Site 4001
Copenhagen, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors