Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer

NCT05519059 | Completed Phase 1

• 1 other identifier: REO 026-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with Dose Limiting Toxicities (DLTs)

  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)

  4 Weeks

Secondary Outcomes (5)

• Objective response rate (ORR)

  24 months

• Disease control rate (DCR)

  24 months

• Progression-free survival (PFS)

  24 months

• Duration of response (DOR)

  24 months

• Overall survival (OS)

  24 months

Study Arms (1)

Patients With Advanced or Metastatic Breast Cancer

EXPERIMENTAL

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

Drug: Pelareorep

Interventions

Pelareorep DRUG

Pelareorep at 1.5×10\^10 TCID50, 3×10\^10 TCID50, 4.5×10\^10 TCID50 on Day 1/2/8/9/15/16 with Paclitaxel at 80 mg/m\^2 on Day 1/8/15 per cycle

Also known as: Paclitaxel

Patients With Advanced or Metastatic Breast Cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) 1.1.
• Anticipated life expectancy ≥3 months.
• Eastern Cooperative Oncology Group (ECOG) performance score (PS) 0 to 1.
• 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.
• Prior endocrinotherapy meeting the followings:
• The subject has received at least one endocrinotherapy regimen, alone or combined with CDK4/6 or mTOR inhibitors, and has experienced progressive disease or intolerability.
• Meeting the following criteria for laboratory tests (provided that there was no blood transfusion, use of G-CSF or use of drug for correction of, e.g., blood components, etc., within 14 days prior to the test):
• Test Criterion Hematology Neutrophil count ≥ 1.5 ×10\^9/L
• Platelet count ≥ 100 ×10\^9/L RBC count ≥ 90g/L Lymphocyte count ≥0.8×10\^9/L Biochemistry

You may not qualify if:

• 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
• Unstable angina (despite the attempt to control it with drug)
• Heart failure (New York Heart Association \[NYHA\] ≥ class II)
• QTc interval ≥470ms (Fridericia's Correction Formula: QTcF= QT msec/(RR sec)0.33)
• Left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) ≤50%
• Uncontrolled hypertension (BP\>150/90mmHg despite optimal treatment)

Sponsors & Collaborators

• Adlai Nortye Biopharma Co., Ltd.: lead

Study Sites (1)

Bethune First Hospital of Jilin University

Changchun, Jilin, 130012, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

reolysin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Wei Li, M.D.

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

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: August 25, 2022
• First Posted: August 29, 2022
• Study Start: October 11, 2021
• Primary Completion: September 29, 2022
• Study Completion: May 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)