PTX-35 in Patients With Advanced Solid Tumors

STATUS

Recruiting
participants needed

30
sponsor

Pelican Therapeutics, Inc.

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Updated on 19 February 2024

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platelet count

metastasis

solid tumour

gilbert's syndrome

neutrophil count

solid tumor

monoclonal antibodies

liver metastasis

antibody therapy

unresectable solid tumor

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

Description

This is an open-label, single arm, first-in-human, Phase I study of intravenous administration of PTX-35 to patients with advanced solid tumors refractory to, or ineligible for, or who refuse available SOC. Five escalating dose levels of PTX-35 will be explored using a traditional 3+3 design based on dose-limiting toxicities (DLTs) until optimal immunological dose (OID) or maximum tolerated dose (MTD) is established.

Details

Condition	Advanced Solid Tumor
Age	18-100 years
Treatment	PTX-35
Clinical Study Identifier	NCT04430348
Sponsor	Pelican Therapeutics, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last treatment with PTX-35
Exclusion Criteria
	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
	Intravenous treatment with antimicrobial therapy completed less than two weeks prior to first dose, or
	Oral treatment with antimicrobial therapy completed less than one week prior to first dose. Prophylactic treatment with antibiotics (e.g. for dental extractions) is allowed
	Have had major surgery (requiring general anesthesia or inpatient hospitalization) within four weeks before first administration of PTX-35
	Have had a known tetanus/diphtheria vaccine within the past 10 years
	Have known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least two years
	Have known previously untreated or symptomatic metastases in the brain or spinal cord requiring steroids. Patients with treated and stable CNS metastases may be enrolled after approval of the sponsor and/or Medical Monitor
	Have any other ongoing significant, uncontrolled medical condition in the opinion of the Investigator
	Have known positive serology for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (except in cases of immunity after cured infection). Testing not required
	Have a history of substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result
	Be a female patient who is pregnant or breast feeding

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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PTX-35 in Patients With Advanced Solid Tumors