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Advanced Solid TumorsPhase 1NCT05234853

Safety of PUR001 Monotherapy in Patients With Advanced Solid Tumors

A Phase 1 study testing PUR001 in people with Advanced Solid Tumors, run by Purinomia Biotech, Inc. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a Phase I, First-In-Human, open label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of PUR001, an anti-CD39 monoclonal antibody, in adult patients with advanced solid tumors, as monotherapy. 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?
PUR001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
28 Apr 2022to Dec 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

  • Able to sign informed consent and comply with the protocol
  • ≥ 18 years of age, at the time of signing informed consent
  • Histologically or cytologically documented advanced/metastatic solid tumors who have received at least one line of prior systemic chemotherapy and progressed
  • At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors
  • ECOG performance status of 0 or 1
  • Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:
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  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  • Hemoglobin (Hgb) ≥ 8 g/dl
  • Platelets (plt) ≥ 75 × 10^9/L
  • AST/SGOT and ALT/SGPT ≤ 2.5 × Upper Limit of Normal (ULN) or ≤ 5.0 × ULN if liver metastases are present
  • Total bilirubin ≤ 1.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 30 mL/min (Cockcroft Gault formula
  • Negative pregnancy test within 72 hours before starting study treatment in all pre-menopausal women and women < 12 months after the onset of menopause
  • Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment

Who cannot join

  • Women who are pregnant or lactating
  • Women of child-bearing potential (WOCBP) who do not use adequate birth control.
  • Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment
  • Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy
  • Impaired cardiac function or significant diseases, including but not limited to any of the following:
  • LVEF < 45% as determined by MUGA scan or ECHO
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  • Congenital long QT syndrome
  • QTcF ≥ 480 msec on screening ECG
  • Unstable angina pectoris ≤ 3 months prior to starting study drug
  • Acute myocardial infarction ≤ 3 months prior to starting study drug
  • Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening)
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 5 half-lives or 3 weeks, whichever is shorter, (except for: 4 weeks for other anti-CD39 monoclonal antibody, 6 weeks for nitrosourea or mitomycin-C) prior to starting study drug
  • Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy
  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy
  • Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory; patients with well controlled HIV might be enrolled per investigator's discretion and Sponsor approval).
  • Evidence of active infection with Hepatitis B or Hepatitis C that is not adequately controlled. (For patients with known prior history of Hepatitis B or Hepatitis C, enrollment may be allowed per investigator's discretion and Sponsor approval.)
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial. For example, conditions that depend on the establishment of collateral circulation, such as peripheral arterial vascular disease, myocardial infraction recovery period, etc.
  • Patients with a clinical history of ≥ grade 3 hypersensitivity reaction (HSR) to biologicals that cannot be controlled by steroids.

Trial locations and contacts

1 site in 1 country.

Clinical Development contact

781-874-0926

clinical.development@purinomia.com

United States1 site, 1 recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Rabia Khan, 713-563-4667, RKhan@mdanderson.org

    Sarina Piha-Paul, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase I, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of PUR001 Administered Intravenously in Adult Patients With Advanced Solid Tumors

This is a Phase I, First-In-Human, open label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of PUR001, an anti-CD39 monoclonal antibody, in adult patients with advanced solid tumors, as monotherapy. A "3+3" design will be used to determine MTD and RP2D. .

Read the detailed description

This is a Phase I, First-In-Human, open label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of PUR001 in adult patients with advanced solid tumors, as monotherapy.

The primary objective of this study is to determine the dose-limiting toxicity(ies) (DLT) and/or maximum tolerated dose (MTD) of PUR001 monotherapy in patients with advanced/metastatic solid tumors.

Study consists of two parts:

Dose Escalation Cohort and Dose Expansion Cohort.

Dose limiting toxicity (DLT) will be evaluated and managed per the pre-defined DLT criteria and rules specified in the protocol. MTD and/or RP2D will be confirmed in a dose confirmation cohort.

Being tested
PUR001

What participants receive

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

  • PUR001Drug

    Monoclonal antibody

Study groups in NCT05234853
Study groupRoleWhat they receive
Monotherapy classic "3+3" design dose escalation and expansionExperimentalNot described
Receives: Drug: PUR001

What is being measured

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

  1. Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD), if reached

    Safety and tolerability of PUR001 as a single agent

    Measured: 1-1.5 years

Secondary outcomes (12)

  1. Number of participants with treatment-related adverse events (AEs)

    Safety and tolerability of PUR001 as a single agent. AEs will be assessed per CTCAE v5.0 and may include, but is not limited to, clinically abnormal laboratory tests, physical exams, vital signs, electrocardiograms, and ECOG performance status.

    Measured: 1-1.5 years

  2. Number of participants with positive Anti-therapeutic antibody (ATA)

    Safety and tolerability of PUR001 as a single agent

    Measured: 1-1.5 years

  3. Area under the concentration time curve (AUC 0-last)

    Pharmacokinetic (PK) profile of PUR001 as a single agent

    Measured: 1-1.5 years

  4. Maximum plasma concentration (Cmax)

    Pharmacokinetic (PK) profile of PUR001 as a single agent

    Measured: 1-1.5 years

  5. Time to Maximum Plasma Concentration (Tmax)

    Pharmacokinetic (PK) profile of PUR001 as a single agent

    Measured: 1-1.5 years

  6. Half-life (T1/2)

    Pharmacokinetic (PK) profile of PUR001 as a single agent

    Measured: 1-1.5 years

  7. Mean Residence Time (MRT)

    Pharmacokinetic (PK) profile of PUR001 as a single agent

    Measured: 1-1.5 years

  8. Volume of Distribution (Vd)

    Pharmacokinetic (PK) profile of PUR001 as a single agent

    Measured: 1-1.5 years

  9. Objective Response Rate (ORR)

    Preliminary efficacy profile of PUR001 as a single agent

    Measured: 1-1.5 years

  10. Disease Control Rate (DCR)

    Preliminary efficacy profile of PUR001 as a single agent

    Measured: 1-1.5 years

  11. Duration of Response (DOR)

    Preliminary efficacy profile of PUR001 as a single agent

    Measured: 1-1.5 years

  12. Progression free survival (PFS)

    Preliminary efficacy profile of PUR001 as a single agent

    Measured: 1-1.5 years

Timeline

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

  1. First posted10 Feb 2022
  2. Study start28 Apr 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (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
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234853
Sponsor's protocol ID
PUR001X1101
Status last verified
Jan 2023
First submitted
27 Dec 2021
Last updated
20 Jan 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 PUR001 in people with Advanced Solid Tumors, run by Purinomia Biotech, 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 14 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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?

Results are not available in the source record.

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

Contact Clinical Development (781-874-0926, clinical.development@purinomia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD), if reached (time frame: 1-1.5 years). 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 NCT05234853.

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 20 Jan 2023.

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