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SarcomaPhase 1NCT04837677

A Study of PRT1419 in Patients With Advanced Solid Tumors

A Phase 1 study testing PRT1419 in people with Sarcoma and Melanoma, run by Prelude Therapeutics Incorporated at 7 sites 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 is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Melanoma, Lung Cancer
What is being tested?
PRT1419
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
7 sitesUnited States
Study dates
11 Aug 2021to 6 Feb 2023
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

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
  • Left ventricular ejection fraction of ≥ 50%
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial
  • Patients must have recovered from the effects of any prior cancer related therapy, radiotherapy or surgery (toxicity ≤ Grade 1)
  • All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 28 days, whichever is longer before study entry
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  • Most recent lab values meet the following criteria:
  • Absolute neutrophil count > 1.0 x 10^3/μL;
  • Platelet count > 75,000/μL;
  • Hemoglobin > 9.0 g/dL
  • Histologically confirmed advanced or metastatic solid tumor indicated below that is relapsed, refractory, or intolerant to available therapies with known benefit:
  • Sarcoma not amendable to curative treatment with surgery or radiotherapy;
  • Melanoma (non-resectable or metastatic);
  • Small cell lung cancer (extensive-stage);
  • Non-small cell lung cancer;
  • Triple negative breast cancer (histopathologically or cytologically confirmed).
  • Esophageal cancer
  • Cervical cancer
  • Head and neck cancer

Who cannot join

  • Known hypersensitivity to any of the components of PRT1419
  • Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression
  • Female patients who are pregnant or lactating
  • Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption
  • Mean QTcF interval of >480 msec
  • History of heart failure, additional risk factors for arrhythmias or requiring concomitant medications that prolong the QT/QTc interval
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  • HIV positive; known active hepatitis B or C
  • Uncontrolled intercurrent illnesses
  • Treatment with strong inhibitors of CYP2C8
  • Prior exposure to an MCL1 inhibitor
  • History of another malignancy except:
  • Malignancy treated with curative intent with no known active disease for >2 years at study entry;
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
  • Adequately treated carcinoma in situ without evidence of disease;
  • Other concurrent low-grade malignancies (i.e chronic lymphocytic leukemia (Rai 0)) may be considered after consultation with Sponsor.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Florida Cancer Specialists

    Lake Mary, Florida, 32746

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 in Patients With Advanced Solid Tumors

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.

Read the detailed description

This is a multicenter, open-label, dose-escalation Phase 1 study of PRT1419, a MCL1 inhibitor, evaluating patients with relapsed or refractory solid tumors, including breast, lung, sarcoma and melanoma as part of a 28-day treatment cycle. The study will employ a "3+3" dose escalation design. The dose may be escalated until a dose limiting toxicity is identified.

Being tested
PRT1419
Keywords
MCL1
Medical subject headings
Sarcoma, Melanoma, Lung Neoplasms, Breast Neoplasms, Esophageal Neoplasms, Uterine Cervical Neoplasms, Head and Neck Neoplasms

What participants receive

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

  • PRT1419Drug

    PRT1419 will be administered by intravenous infusion

Study groups in NCT04837677
Study groupRoleWhat they receive
PRT1419ExperimentalPRT1419 will be administered by intravenous infusion
Receives: Drug: PRT1419

What is being measured

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

  1. Dose limiting toxicities (DLT) of PRT1419

    Dose limiting toxicities will be evaluated through the first cycle

    Measured: Baseline through Day 28

  2. Maximally tolerated dose (MTD) and/or optimal biological dose (OBD)

    The MTD and/or OBD will be established for further investigation in participants with advanced solid tumors.

    Measured: Baseline through approximately 2 years

  3. Recommended phase 2 dose (RP2D) and schedule of PRT1419

    The RP2D will be established for further investigation in participants with advanced solid tumors.

    Measured: Baseline through approximately 2 years

Secondary outcomes (4)

  1. Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments

    Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: Baseline through approximately 2 years

  2. Pharmacokinetic profile of PRT1419: maximum observed plasma concentration

    PRT1419 pharmacokinetics will be calculated including the maximum observed plasma concentration

    Measured: Baseline through approximately 2 years

  3. Anti-tumor activity of PRT1419: measurement of objective responses

    Anti-tumor activity of PRT1419 will be based on the measurement of objective responses

    Measured: Baseline through approximately 2 years

  4. Progression-free survival

    Progression-free survival will be calculated from the first administration of PRT1419 until death or until the criteria for disease progression are met

    Measured: Baseline through approximately 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 posted8 Apr 2021
  2. Study start11 Aug 2021
  3. Primary completion6 Feb 2023
  4. Study completion6 Feb 2023

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
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837677
Sponsor's protocol ID
PRT1419-02
Status last verified
Mar 2023
First submitted
5 Apr 2021
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRT1419 in people with Sarcoma and Melanoma, run by Prelude Therapeutics Incorporated at 7 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 19 inclusion and 15 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

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?

Dose limiting toxicities (DLT) of PRT1419 (time frame: Baseline through Day 28). 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 NCT04837677.

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 15 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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