PTX-35 in Patients With Advanced Solid Tumors

NCT04430348 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: PTX35-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety of the Monoclonal Antibody PTX-35 in Patients with Advanced Solid Tumors Refractory to Standard of Care

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Subjects With Any Treatment-emergent Adverse Events (TEAEs) During the Trial

  TEAEs during the trial

  Up to 12 months

Study Arms (6)

PTX-35 Dose Level 1

EXPERIMENTAL

Dose Level 1: PTX-35 0.01 mg/kg

Drug: PTX-35

PTX-35 Dose Level 2

EXPERIMENTAL

Dose Level 2: PTX-35 0.03 mg/kg

Drug: PTX-35

PTX-35 Dose Level 3

EXPERIMENTAL

Dose Level 3: PTX-35 0.10 mg/kg

Drug: PTX-35

PTX-35 Dose Level 4

EXPERIMENTAL

Dose Level 4: PTX-35 0.30 mg/kg

Drug: PTX-35

PTX-35 Dose Level 5

EXPERIMENTAL

Dose Level 5: PTX-35 1.0 mg/kg

Drug: PTX-35

PTX-35 Dose Level 6

EXPERIMENTAL

Dose Level 6: PTX-35 3.0 mg/kg

Drug: PTX-35

Interventions

PTX-35 DRUG

Monoclonal antibody PTX-35

PTX-35 Dose Level 1; PTX-35 Dose Level 2; PTX-35 Dose Level 3; PTX-35 Dose Level 4; PTX-35 Dose Level 5; PTX-35 Dose Level 6

Eligibility Criteria

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

You may qualify if:

• In order to participate in this study, a patient must:
• Be willing and have the capacity to sign the written informed consent form.
• Be male or female of at least 18 years of age at the time of signing informed consent.
• Have a documented diagnosis of metastatic or advanced, unresectable solid tumor disease. Patient must have progressed or recurred following standard of care (SOC) therapies, or are ineligible for, or who refuse other safe and effective SOC therapies, and whom the Investigator believes may benefit from experimental treatment with PTX-35.
• Have an acceptable organ function, as defined below:
• Albumin ≥ 2.5 g/dL
• Total bilirubin \< 3.0 × upper limit of normal (ULN), unless patient has Gilbert's syndrome
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × ULN, or
• × ULN in the case of liver metastases
• Calculated or measured creatinine clearance \> 35 mL/minute per the Cockcroft-Gault formula
• Absolute neutrophil count ≥ 1,500/mm3
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mm3
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Have life expectancy of at least three months.

You may not qualify if:

• In order to participate in this study, a patient must not:
• Have received any systemic anticancer therapy including small molecules, chemotherapy, radiation therapy, monoclonal antibodies or any other experimental drug within 4 weeks of first dose of PTX-35. Adjuvant anti hormonal treatment(s) for prior breast cancer or prostate cancer are allowed. (Note: washout for palliative radiation therapy is 2 weeks).
• Have clinically significant cardiac disease, including:
• Onset of unstable angina within 6 months of signing the Informed Consent Form (ICF).
• Acute myocardial infarction within 6 months of the signing the ICF.
• Known congestive heart failure (Grade III or IV as classified by the New York Heart Association); and/ or a known decreased cardiac ejection fraction (LVEF) of \< 45%.
• Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management.
• Have known or clinically suspected leptomeningeal disease. Stable, previously treated metastases in the brain or spinal cord, are allowed as long as these are considered stable (by CT or MRI), and not requiring systemic corticosteroids.
• Have a history of ≥ Grade 3 allergic reactions, or suspected allergy or intolerance to monoclonal antibody therapies.
• Have a history of suspected cytokine release syndrome (CRS).
• Have any known immunodeficiency disorders (testing not required).
• Have received prior allogeneic stem cell transplant.
• Have ongoing or current autoimmune disease. Permanent but stable and manageable immune related adverse events (irAE) from prior therapies are permissible, if prednisone equivalent corticosteroid use does not exceed 10 mg/day.
• Have any other condition requiring concurrent systemic immunosuppressive therapy (other than allowable exceptions which do not exceed 10mg/day of prednisone/corticosteroid use).
• Have clinically significant active viral, bacterial or fungal infection requiring:

Sponsors & Collaborators

• Pelican Therapeutics, Inc.: lead

Study Sites (3)

Providence Cancer Institute, Earle A. Chiles Research Institute

Portland, Oregon, 97213, United States

Location

NEXT Oncology Austin

Austin, Texas, 78705, United States

Location

Next Oncology

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Vice President, Clinical Development
• Organization: NightHawk Biosciences Inc.

info@nighthawkbio.com

9197948950

Study Officials

• Anthony W Tolcher, MD

  Next Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 12, 2020
• Study Start: June 4, 2020
• Primary Completion: November 2, 2022
• Study Completion: June 15, 2023
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)