Safety of PUR001 Monotherapy in Patients With Advanced Solid Tumors

NCT05234853 | Unknown Phase 1 FDA Drug

• 1 other identifier: PUR001X1101
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. A "3+3" design will be used to determine MTD and RP2D. .

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

  Safety and tolerability of PUR001 as a single agent

  1-1.5 years

Secondary Outcomes (12)

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

  1-1.5 years

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

  1-1.5 years

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

  1-1.5 years

• Maximum plasma concentration (Cmax)

  1-1.5 years

• Time to Maximum Plasma Concentration (Tmax)

  1-1.5 years

Study Arms (1)

Monotherapy classic "3+3" design dose escalation and expansion

EXPERIMENTAL

Drug: PUR001

Interventions

PUR001 DRUG

Monoclonal antibody

Monotherapy classic "3+3" design dose escalation and expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Purinomia Biotech, Inc.: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Clinical Development

  Purinomia Biotech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Development

CONTACT

781-874-0926; clinical.development@purinomia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: February 10, 2022
• Study Start: April 28, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

US (1)