NCT04102618 (AWARE-1) is a EARLY_PHASE1 clinical trial of Pelareorep in Breast Cancer, sponsored by Oncolytics Biotech.

Who is sponsoring NCT04102618?

NCT04102618 is sponsored by Oncolytics Biotech.

What drugs are being tested in NCT04102618?

Interventions in NCT04102618: Pelareorep, Letrozole, Atezolizumab, Trastuzumab.

What condition does NCT04102618 study?

NCT04102618 studies Breast Cancer.

Is NCT04102618 still recruiting?

NCT04102618 is currently terminated. Last updated 15 August 2022.

Last reviewed 2022-08-15 · How we verify

NCT04102618: AWARE-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Window-of-opportunity Study of Pelareorep in Early Breast Cancer

Terminated EARLY_PHASE1 Last updated 15 August 2022

What this trial tests

EARLY_PHASE1 trial testing Pelareorep in Breast Cancer in 26 participants. Terminated before completion.

Timeline

29 March 2019

Primary endpoint
20 April 2022

20 April 2022

Quick facts

Lead sponsor	Oncolytics Biotech
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	29 March 2019
Primary completion	20 April 2022
Estimated completion	20 April 2022
Sites	14 locations across Spain

Drugs / interventions tested

Pelareorep — full drug profile →
Letrozole — full drug profile →
Atezolizumab (atezolizumab) — full drug profile →
Trastuzumab (trastuzumab) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Oncolytics Biotech — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to find out if pelareorep in combination with different therapies helps to reduce the growth of breast cancer cells and increase the immune system's response to cancer. This study will also help to understand what this treatment does to the tumor. In addition, the safety of the combination treatments with pelareorep will be evaluated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Type I interferon-mediated tumor immunity and its role in immunotherapy.
Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
Engineering strategies to enhance oncolytic viruses in cancer immunotherapy.
Tian Y, Xie D, Yang L. · · 2022 · cited 199× · PMID 35387984 · DOI 10.1038/s41392-022-00951-x
Oncolytic Viruses: Newest Frontier for Cancer Immunotherapy.
Rahman MM, McFadden G. · · 2021 · cited 107× · PMID 34771615 · DOI 10.3390/cancers13215452
Immunotherapy in triple negative breast cancer: beyond checkpoint inhibitors.
Abdou Y, Goudarzi A, Yu JX, Upadhaya S, et al · · 2022 · cited 81× · PMID 36351947 · DOI 10.1038/s41523-022-00486-y
Current clinical landscape of oncolytic viruses as novel cancer immunotherapeutic and recent preclinical advancements.
Yun CO, Hong J, Yoon AR. · · 2022 · cited 45× · PMID 36091031 · DOI 10.3389/fimmu.2022.953410
Current and future immunotherapy for breast cancer.
Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
Immunotherapy for triple-negative breast cancer: A molecular insight into the microenvironment, treatment, and resistance.
Bai X, Ni J, Beretov J, Graham P, et al · · 2021 · cited 33× · PMID 39036372 · DOI 10.1016/j.jncc.2021.06.001
Immune-Based Therapy in Triple-Negative Breast Cancer: From Molecular Biology to Clinical Practice.
Carlino F, Diana A, Piccolo A, Ventriglia A, et al · · 2022 · cited 26× · PMID 35565233 · DOI 10.3390/cancers14092102

Verify or expand the search:

Other trials of Pelareorep

Trials testing the same drug.

NCT07446322 — FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-S · Phase 2 · not yet recruiting
NCT05514990 — Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AM · Phase 1, PHASE2 · active not recruiting
NCT07280377 — A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezoliz · Phase 1, PHASE2 · recruiting
NCT05519059 — Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer · Phase 1 · completed
NCT04445844 — INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study · Phase 2 · active not recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Oncolytics Biotech trials

Trials by the same sponsor.

NCT07446322 — FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-S · Phase 2 · not yet recruiting
NCT07280377 — A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezoliz · Phase 1, PHASE2 · recruiting
NCT02723838 — Study of Intratumoral REOLYSIN® in Combination With Gemcitabine and Cisplatin as Neoadjuvant Therapy in Muscle-invasive · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04102618 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oncolytics Biotech
Last refreshed: 15 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04102618.

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