AzTrials
AzTrials

Advanced or Metastatic Breast CancerPhase 1NCT05519059

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

A Phase 1 study testing Pelareorep in people with Advanced or Metastatic Breast Cancer, run by Adlai Nortye Biopharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Advanced or Metastatic Breast Cancer
What is being tested?
Pelareorep
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
11 Oct 2021to 30 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 24Show fewer
  • 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
  • Serum creatinine ≤1.5 × upper limit of normal (ULN) and estimated creatinine clearance ≥40 mL/min (by Cockcroft -Gault formula, see Appendix 3) Albumin ≥30g/L Total bilirubin ≤1.5 × ULN
  • AST and ALT ≤ 2.5 × ULN (or ≤3.0 × ULN in the presence of documented liver metastasis) Coagulation International Normalized Ratio (INR) or prothrombin time (PT)
  • 1.5 × ULN Activated partial thromboplastin time (aPTT)
  • 1.5 × ULN Urinalysis (24h urine protein quantitation if necessary) Urine protein ≤1+; if ≥2+, 24h protein quantitation is required and should be <1.0g/24h
  • Duration from the end of last non-study treatment to the first study treatment:
  • Prior chemotherapy or other investigational product: >4 weeks or >5 half lives, whichever occurred later (or >4 weeks if the half life is unavailable)
  • Surgical treatment or radiotherapy: >3 weeks
  • Endocrinotherapy or small-molecular targeted therapy: >2 weeks
  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to the first study treatment, be willing to use appropriate and reliable contraception throughout the treatment period and for 6 months after last study treatment, and be willing to undergo additional pregnancy tests during the study.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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)
  • Severe hematological, gastrointestinal, respiratory or endocrine disorders.
  • Known hypersensitivity to paclitaxel or any of its excipients , or to Pelareorep or any of its components.
  • Patients who have been enrolled into another clinical study of drugs, medical devices or prosthesis implantation, or where ≤4 weeks have elapsed since discontinuation of another investigational drug or medical device or prosthesis implantation.
  • Pregnant or lactating women.
  • Other circumstances that in the investigator's opinion may affect patient's protocol compliance or evaluation of study indicators and thus make it inappropriate for the patient to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Bethune First Hospital of Jilin University

    Changchun, Jilin, 130012

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Pelareorep
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PelareorepDrug

    Also called Paclitaxel

    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

Study groups in NCT05519059
Study groupRoleWhat they receive
Patients With Advanced or Metastatic Breast CancerExperimentalPatients will receive Pelareorep with Paclitaxel for 8 cycles (28 days/cycle).
Receives: Drug: Pelareorep

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 4 Weeks

Secondary outcomes (5)

  1. Objective response rate (ORR)

    The rate of patients with complete response and partial response in all tumor evaluable patients

    Measured: 24 months

  2. Disease control rate (DCR)

    The rate of patients with complete response, partial response and stable disease in all tumor evaluable patients

    Measured: 24 months

  3. Progression-free survival (PFS)

    The duration from the date of 1st dose to imaging progression or death, which earlier

    Measured: 24 months

  4. Duration of response (DOR)

    The duration from the first PR/CR to progression

    Measured: 24 months

  5. Overall survival (OS)

    The duration from the date of 1st dose to death

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start11 Oct 2021
  3. Primary completion29 Sep 2022
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519059
Sponsor's protocol ID
REO 026-1
Status last verified
Aug 2022
First submitted
25 Aug 2022
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pelareorep in people with Advanced or Metastatic Breast Cancer, run by Adlai Nortye Biopharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Dose Limiting Toxicities (DLTs) (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05519059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in