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Solid Tumors, AdultPhase 1NCT04739293

Study of ON 123300 in Patients With Advanced Cancer

A Phase 1 study testing ON123300 in people with Solid Tumors, Adult, run by Traws Pharma, Inc. at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will investigate the safety of the drug ON 123300 at increasing doses to determine the best dose to use in future clinical trials. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Adult
What is being tested?
ON123300
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesUnited States
Study dates
13 May 2021to Oct 2024
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

  • ≥ 18 years of age the time of signing the informed consent form (ICF);
  • Histological or cytological evidence of advanced and/or metastatic cancer,
  • For Dose Escalation Cohorts, patients with measurable or non-measurable disease;
  • For RP2D Expansion Cohort, patients with measurable disease;
  • Patients must have received and failed at least one prior approved treatment, or have no therapeutic options available as deemed appropriate by their treating physician;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of < 2;
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  • Life expectancy of > 3 months;
  • Patients must be able to swallow oral capsules;
  • Women of child-bearing potential must have a negative serum screening for pregnancy within 14 days prior to screening. Women and men of child-bearing potential must agree to use highly effective methods of birth control before entry and throughout the study, for up to 12 weeks following the last dose of ON 123300.
  • Patients must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted;
  • Patients must have the ability to understand the nature of the study and any hazards of participating in the study and communicate satisfactorily with the investigator to participate in the study.
  • Patients must be willing and able to adhere and comply to the requirements of the entire study including study visit schedule and other protocol requirements;
  • Have adequate organ function, including:
  • Hematologic: i. absolute neutrophil count (ANC) ≥1.0 × 109/Liter (L) ii. platelets ≥100 × 109/L, and iii. hemoglobin ≥8 g/deciliter (dL). b. Hepatic: i. Total bilirubin ≤1.5 times the upper limit of normal (ULN) and ii. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times ULN (or ALT and AST ≤5 times ULN if liver metastases are present).
  • Renal: i. Serum creatinine ≤1.5 times ULN. or estimated creatinine clearance (calculated according to normal institutional practice) greater than 50 ml/min.

Who cannot join

  • Patients that have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study or present an unacceptable risk to the patient;
  • Patients at risk for Torsades de pointes (TdP):
  • Who have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula, or
  • who have a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or
  • who are currently taking medications that prolong the QT/QTc interval;
  • Patients with a diagnosis of hematological malignancies except for non-Hodgkin's lymphoma;
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  • Have received recent chemotherapy, hormonal therapy, other targeted cancer treatment, or investigational therapy within 14 days of planned first dose;
  • Patients currently taking or within 5 half-lives of taking strong inducers and inhibitors of CYP2C8 and CYP3A4;
  • History of allergic reaction attributed to compounds of similar chemical or biologic composition/structure to ON 123300 (e.g. prior CDK4/6 inhibitors);
  • Uncontrolled intercurrent illness including but not limited to ongoing or active infection, bleeding, congestive heart failure, unstable angina, cardiac arrhythmia, oxygen-dependent lung disease, psychiatric illness/social situations that limit participation compliance with study procedures and requirements;
  • Patients with a recent history of venous thromboembolic events, defined as event occurring ≤ 6 months prior to screening and also currently on therapy;
  • Patients with baseline Grade ≥ 2 diarrhea;
  • Patients with Grade ≥ 3 hypercalcemia (Corrected serum calcium > 12.5 mg/dL);
  • Pregnant or nursing mothers;
  • Have had major surgery within 14 days prior to screening to allow for post-operative healing of the surgical wound and site(s).
  • Have received recent (within 28 days prior to screening) live attenuated vaccines.
  • Have active bacterial, fungal or detectable viral infection (e.g. Human Immunodeficiency Virus or Hepatitis B or Hepatitis C).

Trial locations and contacts

3 sites in 1 country.

United States3 sites, 3 recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

    Douglas Orr, MD, 972-566-3000, Referral@MaryCrowley.Org

    Douglas Orr, MD

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Julie Burns, BS, 616-954-5559, Julie.burns@startmidwest.com

    Manish Sharma, MD

    Recruiting

  • Greenville Health System, Institute for Oncology Clinical Research

    Greenville, South Carolina, 29605

    Fiona Davidson, 864-455-3600, Fiona.Davidson@prismahealth.org

    Lisa Johnson, 864-455-3600, Lisa.Johnson@prismahealth.org

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of ON 123300 Capsules Administered Orally as Escalating Daily Doses in Patients With Advanced Cancer Relapsed or Refractory to at Least One (1) Prior Line of Therapy

This study will investigate the safety of the drug ON 123300 at increasing doses to determine the best dose to use in future clinical trials.

Read the detailed description

After being informed about the study including potential risks, patients giving written informed consent will proceed to a screening period when assessments will be performed to determine whether the patient is eligible to participate in the study. If the patient is eligible, they will start to receive ON 123300 as capsules every day. On day 1 and Day 8 of the study, patients will be required to provide eight blood samples to allow measurement of the amount of drug in their blood. Three ECGs will also be performed during this time. Patients will continue to receive ON 123300 until disease progression, unacceptable toxicity, or patient or physician decision to stop.

The first group of patients will receive 40mg of ON 123300 daily, the next group 80mg of ON 123300, the 120mg, etc. until the correct dose has been determined for future studies.

Patients will visit the clinic on Days 1, 2, 8, and 9, then weekly for the first month, then every two weeks for two more months, then every month.

Being tested
ON123300

What participants receive

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

  • ON123300Drug

    Also called HX 301

    ON 123300 hard gelatin capsules

Study groups in NCT04739293
Study groupRoleWhat they receive
ON 123300ExperimentalON 123300 capsules at increasing doses per cohort, starting at 40 mg
Receives: Drug: ON123300

What is being measured

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

  1. Incidence of Dose Limiting Toxicities (DLT)

    Incidence of protocol defined toxicities that would result in stopping dosing

    Measured: First 28 days of dosing

  2. Incidence of adverse events (AE)

    Adverse events as measured by CTCAE version 5.0

    Measured: Consent to 30 days after last dose

  3. Abnormal Laboratory Test results

    Changes and trends in standard hematology and chemistry blood tests

    Measured: Consent to 30 days after last dose

Secondary outcomes (7)

  1. Establish the recommended phase 2 dose (RP2D)

    Incidence of DLTs

    Measured: First 28 day cycle

  2. Pharmacokinetics of ON 123300 and 2 metabolites - Cmax

    Maximum plasma concentration

    Measured: Intense PK on Cycle1 Day1 and Day 8; Single samples pre-dose on Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)

  3. Pharmacokinetics of ON 123300 and 2 metabolites - Tmax

    Time to reach Cmax

    Measured: Intense PK on Cycle1 Day1 and Day 8; Single samples pre-dose on Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)

  4. Pharmacokinetics of ON 123300 and 2 metabolites - AUClast

    The area under the plasma concentration-time curve (AUC) calculated to the last quantifiable sample

    Measured: Intense PK on Cycle1 Day1 and Day 8; Single samples pre-dose on Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)

  5. Pharmacokinetics of ON 123300 and 2 metabolites - T1/2

    Terminal phase elimination half-life

    Measured: Intense PK on Cycle1 Day1 and Day 8; Single samples pre-dose on Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)

  6. Pharmacokinetics of ON 123300 and 2 metabolites - CL/F

    The apparent oral clearance

    Measured: Intense PK on Cycle1 Day1 and Day 8; Single samples pre-dose on Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)

  7. Pharmacokinetics of ON 123300 and 2 metabolites - Vss

    Steady state volume of distribution

    Measured: Intense PK on Cycle1 Day1 and Day 8; Single samples pre-dose on Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)

Timeline

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

  1. First posted4 Feb 2021
  2. Study start13 May 2021
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2024 (estimated)

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
Sequential
Model description
3+3 dose escalation design with expansion cohort at recommended phase 2 dose
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739293
Sponsor's protocol ID
19-01
Status last verified
Dec 2023
First submitted
29 Jan 2021
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ON123300 in people with Solid Tumors, Adult, run by Traws Pharma, Inc. at 3 sites 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 17 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicities (DLT) (time frame: First 28 days of dosing). The study lists 3 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 NCT04739293.

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 7 Dec 2023.

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