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Pelareorep

Phase 4

Advanced or Metastatic Breast Cancer | Small molecule | Oncology |Adlai Nortye Ltd. American Depositary Shares|Trials Updated: Nov 22, 2023

Pelareorep development status

Highest phase Phase 4 run by Hoffmann-La Roche (NCT01156961)
Phase scored for ANLPhase 1
Registered trials 306+ across 107 sponsors since May 2002

Pelareorep target and mechanism

ModalitySmall molecule

Also known as Paclitaxel

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Pelareorep clinical trials

Pelareorep · 1 trial · 1 indication

Phase 1 1
NCT05519059Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast CancerAdvanced or Metastatic Breast Cancer
COMPLETED15 Analytics
PHASE1COMPLETED
Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer
Advanced or Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Dose Limiting Toxicities (DLTs)
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)

Secondary Endpoints

Objective response rate (ORR)
24 months
Disease control rate (DCR)
24 months
Progression-free survival (PFS)
24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Patients With Advanced or Metastatic Breast CancerEXPERIMENTALPatients will receive Pelareorep with Paclitaxel for 8 cycles (28 days/cycle).

Interventions

NameTypeDescription
PelareorepDRUGPelareorep 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
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Voluntarily participating in this trial and having signed the Informed Consent Form (ICF). 2. Women aged ≥18 and ≤70 years (at the time of signing ICF). 3. Pathohistologically or c...

Countries:China
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Competitive Landscape -Breast Cancer 601 trials (matched to "Advanced or Metastatic Breast Cancer")

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Frequently asked questions about Pelareorep

What is Pelareorep used for?

Pelareorep is an investigational small molecule being studied for the treatment of advanced or metastatic breast cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Pelareorep?

Pelareorep is being developed by Adlai Nortye Ltd., a biopharmaceutical company whose American Depositary Shares trade under the ticker symbol ANL.

What phase is Pelareorep in?

Pelareorep is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 trial has been completed in patients with advanced or metastatic breast cancer.

What clinical trials is Pelareorep in?

Pelareorep has one completed Phase 1 clinical trial, NCT05519059, which studied Pelareorep and paclitaxel injection in Chinese patients with advanced or metastatic breast cancer. The trial enrolled 15 female patients aged 18 years and older.

Is Pelareorep the same as paclitaxel?

No, Pelareorep is not the same as paclitaxel. Pelareorep is the investigational drug being studied, while paclitaxel is a chemotherapy agent used in combination with Pelareorep in the clinical trial NCT05519059.