RECRUITING

Safety of PUR001 Monotherapy in Patients With Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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, 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. .

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

Quick Facts

Study Start:2022-04-28

Study Completion:2023-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05234853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Able to sign informed consent and comply with the protocol 2. ≥ 18 years of age, at the time of signing informed consent 3. Histologically or cytologically documented advanced/metastatic solid tumors who have received at least one line of prior systemic chemotherapy and progressed 4. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors 5. ECOG performance status of 0 or 1 6. Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by: * 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 7. Negative pregnancy test within 72 hours before starting study treatment in all pre-menopausal women and women \< 12 months after the onset of menopause 8. 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	1. Women who are pregnant or lactating 2. Women of child-bearing potential (WOCBP) who do not use adequate birth control. 3. 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 4. 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 5. Impaired cardiac function or significant diseases, including but not limited to any of the following: * LVEF \< 45% as determined by MUGA scan or ECHO * 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 6. Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening) 7. 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 8. 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 9. 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 10. Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy 11. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants 12. 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). 13. 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.) 14. 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. 15. Patients with a clinical history of ≥ grade 3 hypersensitivity reaction (HSR) to biologicals that cannot be controlled by steroids.

Inclusion Criteria

Exclusion Criteria

1. Able to sign informed consent and comply with the protocol
2. ≥ 18 years of age, at the time of signing informed consent
3. Histologically or cytologically documented advanced/metastatic solid tumors who have received at least one line of prior systemic chemotherapy and progressed
4. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors
5. ECOG performance status of 0 or 1
6. Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:
* 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
7. Negative pregnancy test within 72 hours before starting study treatment in all pre-menopausal women and women \< 12 months after the onset of menopause
8. 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

1. Women who are pregnant or lactating
2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.
3. 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
4. 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
5. Impaired cardiac function or significant diseases, including but not limited to any of the following:
* LVEF \< 45% as determined by MUGA scan or ECHO
* 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
6. Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening)
7. 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
8. 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
9. 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
10. Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy
11. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants
12. 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).
13. 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.)
14. 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.
15. Patients with a clinical history of ≥ grade 3 hypersensitivity reaction (HSR) to biologicals that cannot be controlled by steroids.

Contacts and Locations

Study Contact

Clinical Development

CONTACT

781-874-0926

clinical.development@purinomia.com

Principal Investigator

Clinical Development

STUDY_DIRECTOR

Purinomia Biotech, Inc.

Study Locations (Sites)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Purinomia Biotech, Inc.

Clinical Development, STUDY_DIRECTOR, Purinomia Biotech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-28

Study Completion Date2023-12

Study Record Updates

Study Start Date2022-04-28

Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumors