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Etrumadenant

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Arcus Biosciences, Inc.|Last Updated: Jul 22, 2025

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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical trial landscape

Etrumadenant · 5 trials · 21 indications

Phase 1 5
NCT04381832Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate CancerProstatic Neoplasms, Castration-Resistant
COMPLETED173 Analytics
NCT03846310A Study to Evaluate Immunotherapy Combinations in Participants With Lung CancerNon Small Cell Lung Cancer Metastatic
COMPLETED77 Analytics
NCT03720678A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal MalignanciesGastroEsophageal Cancer
COMPLETED44 Analytics
NCT03719326A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic MalignanciesTNBC - Triple-Negative Breast Cancer
COMPLETED35 Analytics
NCT03629756A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced MalignanciesNon-small Cell Lung Cancer
COMPLETED48 Analytics
PHASE1COMPLETED
Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
NCT04381832173
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PHASE1COMPLETED
A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer
Non Small Cell Lung Cancer Metastatic
NCT0384631077
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PHASE1COMPLETED
A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies
GastroEsophageal Cancer
NCT0372067844
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PHASE1COMPLETED
A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
TNBC - Triple-Negative Breast Cancer
NCT0371932635
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PHASE1COMPLETED
A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
Non-small Cell Lung Cancer
NCT0362975648
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR) in Stage 1 and 2
From study enrolment until participant discontinuation, or first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 3-5 years)

ORR defined as the composite proportion of participants with a Prostate Specific Antigen (PSA) and/or radiographic complete response (CR) and partial response (PR) determined by the investigator according to the Prostate Cancer Working Group 3 (PCWG3) criteria

Incidence and Severity of AEs and Serious Adverse Events (SAEs) in Stage 1
From first dose date to 90 days after the last dose (approximately 1.5 years)
Percentage of participants with Adverse Events
From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
From first study treatment administration through Day 21
Incidence of Adverse Events (AEs)
From first dose date to 90 days after the last dose (Approximately 1 year)
Incidence of dose-limiting toxicities (DLTs) during dose escalation phase
From first dose date to 28 days after the first dose
Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase
From first dose date to 28 days after the first dose
Secondary Endpoints
Percentage of participants with a PSA response in Stage 1 and 2
From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
Percentage of participants with Radiographic Response in Stage 1 and 2
From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
Percentage of Participants with Disease Control Rate in Stage 1 and 2
From study enrollment until disease progression or loss of clinical benefit (approximately 3-5 years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamideEXPERIMENTALParticipants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide
Stage 2: enzalutamideACTIVE_COMPARATORParticipants will receive standard oral enzalutamide
Stage 1 and 2: Etrumadenant + zimberelimab + docetaxelEXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab and standard IV docetaxel
Stage 2: docetaxelACTIVE_COMPARATORParticipants will receive standard dose of IV docetaxel
Stage 1 and 2: Etrumadenant + zimberelimabEXPERIMENTALOral etrumadenant in combination IV zimberelimab
Stage 2: Etrumadenant + zimberelimab + quemliclustatEXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab and IV quemliclustat
Stage 2: Etrumadenant + quemliclustatEXPERIMENTALParticipants will receive oral etrumadenant in combination with IV quemliclustat
Stage 1: Etrumadenant + zimberelimab PK Sub-StudyEXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab
Stage 1 and 2: Etrumadenant + SGEXPERIMENTALParticipants will receive oral etrumadenant in combination with IV SG.
Stage 1 and 2: Etrumadenant + Zimberelimab + SGEXPERIMENTALParticipants will receive oral etrumadenant in combination with IV zimberelimab and SG.
Dose Escalation Arm AEXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer.
Dose Escalation Arm BEXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer.
Dose Expansion Arm 1EXPERIMENTALZimberelimab will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.
Dose Expansion Arm 2EXPERIMENTALThe etrumadenant at RDE determined from the dose escalation phase will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen and zimberelimab in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.
Dose EscalationEXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal or colorectal cancer.
Dose Expansion-GEEXPERIMENTALThe RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal cancer
Dose Expansion-CRCEXPERIMENTALThe RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with colorectal cancer
Dose Escalation-Arm AEXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Dose Escalation-Arm BEXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Dose Escalation-Arm CEXPERIMENTALDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period.
Dose Expansion-TNBC-Arm 1EXPERIMENTALThe dose given will be determined from the dose escalation part (Arm A).
Dose Expansion-Ovarian Cancer-Arm 2EXPERIMENTALThe dose given will be determined from the dose escalation part (Arm A).
Dose Expansion-TNBC-Arm 3EXPERIMENTALThe dose given will be determined from the dose escalation part (Arm B). .
Dose Expansion-TNBC-Arm 4EXPERIMENTALThe dose expansion will be determined from the dose escalation part (Arm C).
Dose Expansion-advanced clear-cell RCCEXPERIMENTALEtrumadenant at RP2D + zimberelimab
Dose Expansion-mCRPCEXPERIMENTALEtrumadenant at RP2D + zimberelimab
Interventions
NameTypeDescription
EtrumadenantDRUGEtrumadenant is an A2aR and A2bR antagonist
ZimberelimabDRUGZimberelimab is an anti-PD-1 antibody
QuemliclustatDRUGQuemliclustat is a Cluster of Differentiation (CD)73 Inhibitor.
EnzalutamideDRUGEnzalutamide is an androgen receptor inhibitor
DocetaxelDRUGDocetaxel is type of chemotherapy
SGDRUGSacituzumab govitecan is an antibody-drug conjugate
CarboplatinDRUGCarboplatin administered as part of standard chemotherapy regimen
PemetrexedDRUGPemetrexed administered as part of standard chemotherapy regimen
PembrolizumabDRUGPembrolizumab is a humanized anti-PD-1 monoclonal antibody
mFOLFOXDRUGOxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen
IPI-549DRUGIPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
Pegylated liposomal doxorubicin (PLD)DRUGDoxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
nanoparticle albumin-bound paclitaxel (NP)DRUGNP is a microtubule inhibitor for intravenous (IV) use
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Eligibility Criteria
Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites19

General Inclusion Criteria: * Male participants; age ≥ 18 years * Metastatic castrate-resistant prostate cancer while on anti-androgen treatment with castrate levels of testosterone (≤1.7 nanomoles per liter \[nmol/L\] or 50 nanograms per deciliter \[ng/dL\]) * Measurable or non-measurable disease ...

Countries:United StatesCanadaSingaporeSouth KoreaTaiwanAustralia
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Competitive Landscape -Non-Small Cell Lung Cancer 395 trials

Top 20 of 86 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel
Bristol-Myers Squibb CompanyBMY19PHASE3Repotrectinib, Crizotinib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Pfizer Inc.PFE17PHASE3Lorlatinib, Crizotinib
GSK plc Sponsored ADRGSK4PHASE3Dostarlimab, Belrestotug, Pembrolizumab
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
BeyondSpring Inc.BYSI1PHASE3Plinabulin, Docetaxel
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