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Pelareorep

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

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 402 trials (matched to "Advanced or Metastatic Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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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.