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Oleclumab

Phase 3Monoclonal antibody

Oleclumab is an experimental drug being tested to treat certain types of cancer by helping the immune system recognize and attack cancer cells.[1] Oleclumab is currently being investigated across 7 indications[3], with its most advanced program in Phase 3.[1]

Oleclumab is one of 189 small molecule programs targeting Colorectal Carcinoma. It is currently in Phase 3.

7

Indications

23

Total Trials

14

Active Trials

188

Competitors

Pipeline

Status by Indication[3][1]

Indication

Colorectal CarcinomaActive, not recruiting

Pancreatic Ductal AdenocarcinomaRecruiting

Non-Small Cell Lung CancerActive, not recruiting

CancerActive, not recruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

Triple Negative Breast NeoplasmsActive, not recruiting

Phase IIActive, not recruiting

Colorectal CarcinomaPreclinical

Active, not recruiting

Pancreatic Ductal AdenocarcinomaPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

CancerPhase 1

Active, not recruiting

Carcinoma, Non-Small-Cell LungPreclinical

Active, not recruiting

Triple Negative Breast NeoplasmsPreclinical

Active, not recruiting

Phase IIPhase 2

Active, not recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Navelbine

PPierre Fabre Medicament

Oleclumab

SI-B001

SSichuan Baili Pharmaceutical Co., Ltd.

Remeron

OOrganon and Co

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

PD-1 Inhibitors

BBioNTech US Inc.

Valemetostat Tosylate

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalActive, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT03381274

PreclinicalActive, not recruiting

Colorectal Carcinoma

NCT04068610

Q1 2027

PreclinicalActive, not recruiting

Triple Negative Breast Neoplasms

NCT03742102

Q2 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT06606847

Phase 2Active, not recruiting

Metastatic Angiosarcoma

NCT04668300

Q4 2027

Phase 2Active, not recruiting

Borderline Resectable Pancreatic Adenocarcinoma

NCT04940286

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer7 trials

A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06606847·30 enrolled

Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), ARCHON-1 Trial

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03801902·26 enrolled

A Multi-Cancer, Multi-State, Platform Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Pancreatic Adenocarcinoma, Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck to Correlate Clinical, Molecular and Immunologic Parameters With DNA Methylation

Withdrawn·UUniversity Health Network, Toronto·Phase 2·NCT04262388

Show 4 more trials

The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2

Not yet recruiting·MMontefiore Medical Center·Phase 2·NCT07146230·52 enrolled

Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance

Active, not recruiting·AAssistance Publique Hopitaux De Marseille·Phase 2·NCT03833440·114 enrolled

A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05221840·1,051 enrolled

A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05061550·630 enrolled

Advanced Solid Tumors2 trials

MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02503774·192 enrolled

IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04261075·57 enrolled

Phase II1 trial

Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03334617·528 enrolled

Bladder Cancer1 trial

A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)

Completed·—·Phase 1·NCT03773666·12 enrolled

Chemotherapy1 trial

MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.

Completed· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT03611556·213 enrolled

11 more indications

Cancer1 trial

A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT03819465·175 enrolled

Advanced Solid Malignancies1 trial

A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02740985·313 enrolled

Durvalumab1 trial

A Phase 2 Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Multi-Cancer Populations With Correlation to Clinical, Molecular and Immunologic Parameters With DNA MethylaTION

Withdrawn·UUniversity Health Network, Toronto·Phase 2·NCT04262375

Prostate Cancer1 trial

An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04089553·59 enrolled

Metastatic Angiosarcoma1 trial

A Phase II Multi-Arm Study to Test the Efficacy of Oleclumab and Durvalumab in Multiple Sarcoma Subtypes

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04668300·75 enrolled

Borderline Resectable Pancreatic Adenocarcinoma1 trial

Phase II Study of Neoadjuvant Gemcitabine, Nab-paclitaxel, Durvalumab (MEDI4736) (Anti-PD-L1), and Oleclumab (Anti-CD73) in the Treatment of Resectable/Borderline Resectable Primary Pancreatic Adenocarcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04940286·13 enrolled

Luminal B1 trial

Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer: a Phase ll Randomised Trial

Active, not recruiting·JJules Bordet Institute·Phase 2·NCT03875573·147 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT03381274·43 enrolled

Colorectal Carcinoma1 trial

A Phase Ib/II, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT04068610·61 enrolled

Triple Negative Breast Neoplasms1 trial

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT03742102·243 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Durvalumab and Oleclumab in Resectable PDAC: A Window of Opportunity Study (DORA Trial)

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06060405·22 enrolled

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Oleclumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oleclumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oleclumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: 5'-Nucleotidase Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

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