Rilvegostomig

Phase 3Small molecule

AstraZeneca

Rilvegostomig is one of 368 small molecule programs targeting Biliary Tract Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

367

Competitors

Pipeline

Status by Indication[3][1]

Indication

Biliary Tract CancerActive, not recruiting

Non-Squamous Non-Small Cell Lung CancerRecruiting

Gastric CancerActive, not recruiting

Stomach NeoplasmsRecruiting

MelanomaRecruiting

Gastroesophageal AdenocarcinomaRecruiting

Advanced or Metastatic Non-Small Cell Lung CancerRecruiting

Breast CancerRecruiting

Transitional Cell CarcinomaRecruiting

Carcinoma, Non-Small-Cell LungRecruiting

Biliary Tract CancerPhase 3

Active, not recruiting

Non-Squamous Non-Small Cell Lung CancerPhase 3

Recruiting

Gastric CancerPhase 3

Active, not recruiting

Stomach NeoplasmsPhase 2

Recruiting

MelanomaPreclinical

Recruiting

Gastroesophageal AdenocarcinomaPhase 2

Recruiting

Advanced or Metastatic Non-Small Cell Lung CancerPreclinical

Recruiting

Breast CancerPreclinical

Recruiting

Transitional Cell CarcinomaPhase 3

Recruiting

Carcinoma, Non-Small-Cell LungPhase 3

Recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Rilvegostomig

AstraZeneca

Phase 3

1 2

Voltaren

Novartis

Preclinical

1 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Duragesic-100

CCephalon

Preclinical

2 6

Tricor

JJagotec

Preclinical

1 7

Acupan

YYonsei University

Preclinical

1 8

Chantix

PPrism Pharmaceuticals

Preclinical

1 9

Vfend

PPrism Pharmaceuticals

Paracetamol

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

Timeline

Expected Milestones

Q2 2027

Phase 2Active, not recruiting

Gastric Cancer

NCT04379596

Phase 1Recruiting

Non-Squamous NSCLC

NCT04686305

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT06564844

Q3 2027

PreclinicalRecruiting

Breast Cancer

NCT05123482

Q4 2027

Phase 2Recruiting

Endometrial Cancer

NCT05489211

Phase 2Active, not recruiting

Hepatocellular Carcinoma

NCT05775159

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06692738·1,160 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

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06564844·25 enrolled

Show 2 more trials

A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06357533·675 enrolled

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07098338·278 enrolled

Biliary Tract Cancer3 trials

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07221253·1,100 enrolled

DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06467357·620 enrolled

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06109779·760 enrolled

Gastric Cancer2 trials

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07431281·2,130 enrolled

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04379596·452 enrolled

Endometrial Cancer2 trials

DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06989112·600 enrolled

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05489211·454 enrolled

Hepatocellular Carcinoma2 trials

A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06921785·1,220 enrolled

A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05775159·294 enrolled

14 more indications

Gastroesophageal Junction Adenocarcinoma1 trial

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05702229·163 enrolled

Cancer1 trial

Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

Recruiting·PPresage Biosciences·Phase 1·NCT04541108·15 enrolled

Non-squamous NSCLC1 trial

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04686305·244 enrolled

HER2-positive Gastric Cancer1 trial

A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06764875·840 enrolled

Breast Cancer1 trial

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT05123482·460 enrolled

Advanced Gastric Cancer1 trial

Local and Systemic Immune Modulation by Rilvegostomig (AZD2936) in the Treatment of Advanced Gastric Cancer (RILVE Project)

Not yet recruiting·VVall d'Hebron Institute of Oncology·Phase 2·NCT07788664·50 enrolled

Melanoma1 trial

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT07115043·120 enrolled

Gastroesophageal Adenocarcinoma1 trial

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07069712·100 enrolled

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06627647·1,160 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06868277·830 enrolled

Transitional Cell Carcinoma1 trial

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07720284·915 enrolled

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT06996782·152 enrolled

Stomach Neoplasms1 trial

A Phase II Platform Trial of Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer (Neo-VIKTORY)

Recruiting·JJeeyun Lee·Phase 2·NCT06630130·100 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592

Completed·PPresage Biosciences·Phase 1·NCT06366451·17 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Rilvegostomig. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rilvegostomig compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rilvegostomig. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

Rilvegostomig

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Biliary Tract Cancer3 trials

Gastric Cancer2 trials

Endometrial Cancer2 trials

Hepatocellular Carcinoma2 trials

Gastroesophageal Junction Adenocarcinoma1 trial

Cancer1 trial

Non-squamous NSCLC1 trial

HER2-positive Gastric Cancer1 trial

Breast Cancer1 trial

Advanced Gastric Cancer1 trial

Melanoma1 trial

Gastroesophageal Adenocarcinoma1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Transitional Cell Carcinoma1 trial

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

Stomach Neoplasms1 trial

Head and Neck Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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