Cetrelimab

Phase 3Monoclonal antibody

Cetrelimab is one of 257 small molecule programs targeting Chronic Hepatitis B Virus Infection. It is currently in Phase 3.

Indications

Total Trials

Active Trials

256

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Hepatitis B Virus InfectionActive, not recruiting

Metastatic Prostate CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Prostate CancerActive, not recruiting

Bladder CancerActive, not recruiting

Carcinoma, Non-Small-Cell LungRecruiting

NeoplasmsRecruiting

Urinary Bladder NeoplasmsActive, not recruiting

Prostatic Neoplasms, Castration-ResistantActive, not recruiting

Metastatic Castration-Resistant Prostate NeoplasmsRecruiting

Chronic Hepatitis B Virus InfectionPhase 1

Active, not recruiting

Metastatic Prostate CancerPhase 1

Active, not recruiting

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Prostate CancerPhase 1

Active, not recruiting

Bladder CancerPhase 3

Active, not recruiting

Carcinoma, Non-Small-Cell LungPhase 1

Recruiting

NeoplasmsPhase 1

Recruiting

Urinary Bladder NeoplasmsPhase 3

Active, not recruiting

Prostatic Neoplasms, Castration-ResistantPhase 2

Active, not recruiting

Metastatic Castration-Resistant Prostate NeoplasmsPhase 1

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Cetrelimab

Johnson & Johnson

Phase 3

1 2

Gemzar

GGynecologic Oncology Group

Preclinical

72 3

Lenvima

Eisai

Preclinical

6 4

Imjudo

AstraZeneca

Preclinical

5 5

Ofev

Boehringer Ingelheim

Preclinical

7 6

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 7

Remeron

OOrganon and Co

Preclinical

1 8

Tyrosine Kinase Inhibitor

Pfizer

Preclinical

2 9

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

REGN2810

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

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Advanced Urothelial Cancer

NCT03473743

Phase 2Active, not recruiting

Prostatic Neoplasms, Castration-Resistant

NCT03431350

Q1 2027

PreclinicalActive, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05908734

Q3 2027

Phase 2Active, not recruiting

Bladder Cancer

NCT04640623

Q4 2027

Phase 2Active, not recruiting

Metastatic Prostate Cancer

NCT04592237

Clinical

Trials by Indication[1]

Prostate Cancer2 trials

A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03551782·33 enrolled

Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer

Terminated·RRahul Aggarwal·Phase 2·NCT04926181·2 enrolled

Bladder Cancer2 trials

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04640623·220 enrolled

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05714202·1,135 enrolled

Neoplasms2 trials

Phase 1 Study of Intratumoral Administration of JNJ-1761981 ER, an Extended Release Chemotherapy, in Participants With Solid Tumors

Recruiting·JJohnson & Johnson Enterprise Innovation Inc.·Phase 1·NCT07525141·66 enrolled

Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors

Recruiting·JJohnson & Johnson Enterprise Innovation Inc.·Phase 1·NCT06311578·126 enrolled

Carcinoma, Non-Small-Cell Lung2 trials

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT05908734·71 enrolled

A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-Small Cell Lung Cancer

Recruiting·JJohnson & Johnson Enterprise Innovation Inc.·Phase 1·NCT06116786·126 enrolled

Urinary Bladder Neoplasms2 trials

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04658862·518 enrolled

A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04919512·163 enrolled

7 more indications

Non-Small Cell Lung Cancer1 trial

A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer

Recruiting·AAnkyra Therapeutics, Inc·Phase 1·NCT07027514·60 enrolled

Chronic Hepatitis B Virus Infection1 trial

A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05242445·11 enrolled

Solid Tumours1 trial

CD8 PET Imaging in Metastatic Solid Tumours

Recruiting·UUniversity Medical Center Groningen·Phase 2·NCT06534190·30 enrolled

Metastatic Prostate Cancer1 trial

Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04592237·120 enrolled

Advanced Urothelial Cancer1 trial

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT03473743·125 enrolled

Prostatic Neoplasms, Castration-Resistant1 trial

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03431350·136 enrolled

Metastatic Castration-resistant Prostate Neoplasms1 trial

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05818683·300 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Cetrelimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cetrelimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cetrelimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Johnson & Johnson

Cetrelimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Prostate Cancer2 trials

Bladder Cancer2 trials

Neoplasms2 trials

Carcinoma, Non-Small-Cell Lung2 trials

Urinary Bladder Neoplasms2 trials

Non-Small Cell Lung Cancer1 trial

Chronic Hepatitis B Virus Infection1 trial

Solid Tumours1 trial

Metastatic Prostate Cancer1 trial

Advanced Urothelial Cancer1 trial

Prostatic Neoplasms, Castration-Resistant1 trial

Metastatic Castration-resistant Prostate Neoplasms1 trial

References

Drug Info

Quick Facts

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