A Multicenter, Single-Arm, Open-Label Phase I Clinical Study of Pelareorep With Paclitaxel in Advanced or Metastatic Breast Cancer

Adlai Nortye Biopharma Co., Ltd.1 site in 1 country15 target enrollmentOctober 11, 2021

ConditionsAdvanced or Metastatic Breast Cancer

InterventionsPelareorep

DrugsPelareorep

Overview

Phase: Phase 1
Intervention: Pelareorep
Conditions: Advanced or Metastatic Breast Cancer
Sponsor: Adlai Nortye Biopharma Co., Ltd.
Enrollment: 15
Locations: 1
Primary Endpoint: Number of participants with Dose Limiting Toxicities (DLTs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This ia a multicenter, Single-Arm, Open-Label Phase I Clinical Study Evaluating the Safety and Tolerability of Pelareorep Combined with Paclitaxel Injection and the Intracorporal Process of Pelareorep in Chinese Patients with Advanced or Metastatic Breast Cancer.

Detailed Description

This study will enroll patients with advanced or metastatic breast cancer to assess the safety and tolerability of Pelareorep at 1.5×10\^10, 3.0×10\^10, 4.5×10\^10 (TCID50) combined with paclitaxel to fix the MTD or RP2D.

Registry

clinicaltrials.gov

Start Date

October 11, 2021

End Date

May 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Adlai Nortye Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects are eligible to be included in the study only if all of the following criteria apply:
•Voluntarily participating in this trial and having signed the Informed Consent Form (ICF).
•Women aged ≥18 and ≤70 years (at the time of signing ICF).
•Pathohistologically or cytologically documented unresectable advanced or metastatic breast cancer that is suitable for paclitaxel treatment, negative for HER2 amplification/overexpression as defined per the American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines (Appendix 1), and positive for estrogen receptor (ER) or progesterone receptor (PR).
•At least one measurable target lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.
•Anticipated life expectancy ≥3 months.
•Eastern Cooperative Oncology Group (ECOG) performance score (PS) 0 to
•Prior chemotherapy meeting the followings:
•The subject has received no or only 1 chemotherapy regimen (monotherapy or combined treatment) after relapse or metastasis;
•Prior adjuvant, neoadjuvant or first-line chemotherapy with taxanes, if any, has been discontinued for \>12 months by the time of enrollment, and none of the prior therapies were discontinued due to progressive disease or toxicity.

Exclusion Criteria

•A history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumors curatively treated with no evidence of disease for \> 3 years.
•Known active, uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with CNS metastases treated with radiation therapy (WBXRT or SRS) are eligible if \> 28 days following completion of XRT, they show stable disease on post-treatment MRI/CT, are off corticosteroids, and are neurologically stable.
•Patients who have not recovered from acute toxicities of previous therapy(ies), except treatment-related alopecia or stable sensory neuropathy ≤ Grade 2 (CTCAE v5.0).
•Systemic immunosuppressive therapy lasting \>2 weeks within 1 month prior to the first study treatment or immunosuppressants used within the last 7 days including but not limited to prednisone \>10 mg/day or equivalent, yet excluding intermittently used inhaled corticosteroids as bronchodilators or topical steroid injections.
•Positivity for hepatitis B surface antigen (HBsAg) with hepatitis B viral load (HBV-DNA) higher than the laboratory lower limit of detection, or positivity for anti-hepatitis C virus antibody (anti-HCV) with hepatitis C viral load (HCV-RNA) higher than the laboratory lower limit of detection, or positivity for anti-human immunodeficiency virus (HIV) antibody (anti-HIV), or positivity for treponema pallidum antibody.
•Patients with autoimmune diseases.
•A history of opportunistic infection within 1 year, presence of active, uncontrolled infection (clinically significant viral, bacterial, fungal or other infections), antibiotic or antiviral treatment given within 14 days prior to first study treatment.
•Inoculation with live or attenuated virus vaccine within 1 months prior to screening.
•Cardiovascular diseases of clinical significance, including:
•Myocardial infarction within the last 6 months

Arms & Interventions

Patients With Advanced or Metastatic Breast Cancer

Patients will receive Pelareorep with Paclitaxel for 8 cycles (28 days/cycle).

Intervention: Pelareorep

Outcomes

Primary Outcomes

Number of participants with Dose Limiting Toxicities (DLTs)

Time Frame: 4 Weeks

DLTs are defined as study drug-related toxicities graded using Common Terminology Criteria for Adverse events of the National Cancer Institute (NCI CTCAE) V5.0 occurring during DLT period (the first 4 weeks of AN0025 administration in combination with dCRT)