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Advanced Solid TumorsPhase 1NCT03931681

A Study of OKI-179 in Patients With Solid Tumors

A Phase 1 study testing OKI-179 in people with Advanced Solid Tumors, run by OnKure, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Phase 1, single center, open-label study, assessing single agent dose escalation of OKI-179. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
OKI-179
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
8 May 2019to 27 Nov 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following criteria to be eligible for enrollment.
  • Histologically or cytologically confirmed solid tumors, advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy exists, or the patient is ineligible for standard therapy(ies).
  • At least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1 within 14 days prior to Cycle 1 Day 1.
  • Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care.
  • Male or female, ≥ 18 years of age at time of signing consent.
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  • Adequate hematologic and organ function as defined by the following criteria within 14 days prior to Cycle 1 Day 1:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
  • Platelet count ≥ 100 × 109/L; excluding measurements obtained within 3 days after transfusion of platelets.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limits of normal (ULN); if liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 × ULN.
  • Total serum bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN if attributed to Gilbert's Syndrome.
  • Serum creatinine ≤ 1.5 x ULN or Creatinine clearance (CrCl) ≥ 50 mL/min; the CrCl can be measured from urine or calculated from serum creatinine (Cockcroft-Gault Equation).
  • Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) test within 14 days prior to Cycle 1 Day 1.
  • Male patients and female patients of childbearing potential must agree to use an effective method of contraception per institutional standard prior to the first dose and for 90 days after the last dose of OKI-179.
  • Willingness and ability to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Who cannot join

  • Patients meeting any of the following criteria are ineligible for enrollment in the study:
  • Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
  • Major surgery within 28 days (the surgical incision should be fully healed prior to study drug administration).
  • Radiation therapy within 21 days; however, if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient is eligible irrespective of the end date of radiotherapy. None of the recently irradiated lesions can be included in the measurable disease assessment.
  • Cytotoxic therapy within 21 days (nitrosoureas or mitomycin within 42 days, capecitabine within 14 days).
  • Monoclonal antibodies within 28 days.
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  • Current use of an investigational agent that is not expected to be cleared by Cycle 1 Day 1.
  • Note: Continuation of luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, bisphosphonates or denosumab for bone metastases.
  • Side effects from prior treatment interventions not resolved to a Grade ≤ 1 (except alopecia or peripheral neuropathy).
  • Prior Histone deacetylase (HDAC), pan-deacetylase (DAC), heat shock protein 90 (HSP90) inhibitors or valproic acid for the treatment of cancer.
  • Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer or others deemed to be cured by surgery alone or surgery plus radiotherapy in the judgment of the Investigator may enroll irrespective of the time of diagnosis.
  • Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
  • Any severe concurrent disease or condition (including active systemic infection requiring systemic therapy, uncontrolled diabetes mellitus, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, or cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation.
  • Known symptomatic active central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable doses of corticosteroids for at least 2 weeks prior to enrollment for brain metastasis is allowed.
  • Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
  • Known positive serology for the human immunodeficiency virus (HIV) (HIV 1/2 antibodies) or acquired immunodeficiency syndrome (AIDS)-related illness, and/or known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative]).
  • Pregnant or lactating females.
  • 12-lead electrocardiography (ECG) demonstrating a QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≥ 480 msec for males and ≥ 480 msec for females (mean of the triplicate ECG measurements), with the exception for patients with an atrioventricular pacemaker or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
  • History or current evidence of congenital long QT syndrome.
  • Taking medications that lead to significant QT prolongation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: A Phase 1 Study of OKI-179 as a Single Agent in Patients With Advanced Solid Tumors

This study is a Phase 1, single center, open-label study, assessing single agent dose escalation of OKI-179.

Being tested
OKI-179

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OKI-179Drug

    OKI-179 single agent

Study groups in NCT03931681
Study groupRoleWhat they receive
Experimental: Phase 1 - Dose EscalationExperimentalDose escalation trial evaluating OKI-179 given orally on a daily basis. Patients will take OKI-179 orally (PO) on Days 1 - 4, 8 - 11 and 15 - 18 in 21-day cycles (± 3 days), under fasted conditions. The design is a modified 3+3 design to determine the maximum tolerated dose and allows for additional cohorts enrolling subjects with an alternative dosing schedule such as OKI-179 orally (PO) daily on Days 1 - 5, 8 - 12 and 15 - 19 per 21-day cycles or Days 1 - 21 per 21-day cycles to determine the maximum tolerated dose for continuous daily dosing.
Receives: Drug: OKI-179

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)

    Tolerability

    Measured: 2 years

  2. Determine the safety of the drug according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5

    • Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5
    • Incidence and severity of Serious Adverse Events
    • Incidence and severity of dose-limiting toxicities (DLTs)
    • Findings of changes in clinical laboratory abnormalities
    • Changes in triplicate 12-lead electrocardiogram (ECG) parameters
    • Changes in the Eastern Cooperative Oncology Group (ECOG) performance status (PS)
    • Changes in physical examination findings

    Measured: 2 years

Secondary outcomes (6)

  1. Maximum Concentration (Cmax) of OKI-179 and OKI-006 in Plasma

    Plasma concentrations of OKI-179 and OKI-006 will be measured to determine the maximum observed concentration for each compound.

    Measured: 2 years

  2. Area Under the Curve (AUC) for OKI-179 and OKI-006 in Plasma

    Plasma concentrations of OKI-179 and OKI-006 will be measured to determine the AUC for each compound.

    Measured: 2 years

  3. Area Under the Curve (AUC) for OKI-179 and OKI-006 in Urine

    Urine concentrations of OKI-179 and OKI-006 will be measured to determine the AUC for each compound.

    Measured: 2 years

  4. Time to Maximum Concentration (Tmax) for OKI-179 and OKI-006 in Plasma

    Plasma concentrations of OKI-179 and OKI-006 will be measured to determine the Tmax for each compound.

    Measured: 2 years

  5. Time to Maximum Concentration (Tmax) for OKI-179 and OKI-006 in Urine

    Urine concentrations of OKI-179 and OKI-006 will be measured to determine the Tmax for each compound.

    Measured: 2 years

  6. Efficacy as measured by periodic CT/MRI scans using the revised Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

    • Fraction of patients who have a Complete Response
    • Fraction of patients who have a Partial Response
    • Duration of response (DOR)
    • Progression free survival
    • Overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2019
  2. Study start8 May 2019
  3. Primary completion27 Nov 2021
  4. Study completion27 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03931681
Sponsor's protocol ID
OKI-179-101
Status last verified
Dec 2021
First submitted
17 Apr 2019
Last updated
6 Dec 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OKI-179 in people with Advanced Solid Tumors, run by OnKure, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03931681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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