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AZD4360

Phase 1

Gastric Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 20, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment117
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06921928Study for AZD4360 in Participants With Advanced Solid TumoursPHASE1 RECRUITING 117Apr 29, 2025Dec 16, 2027May 20, 202618 United States, China +3
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Study Endpoints
Primary Endpoints
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
Through study completion, up to approximately 2 years

To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and/or a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.

Secondary Endpoints
Objective Response Rate (ORR)
Through study completion, up to approximately 2 years
Duration of Response (DoR)
Through study completion, up to approximately 2 years
Disease Control Rate (DCR)
Through study completion, up to approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD4360 MonotherapyEXPERIMENTALAZD4360 Monotherapy
Interventions
NameTypeDescription
AZD4360DRUGAntibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. Participant must be ≥ 18 at the time of signing the ICF. 2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. 3. Minimum life expectancy of 12 weeks in the opinion of the Inve...

Countries:United StatesChinaGermanyJapanUnited Kingdom
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Competitive Landscape -Gastric Cancer 118 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab+ paclitaxel, Paclitaxel, Docetaxel, Irinotecan
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Merck & Co., Inc.MRK1PHASE3pembrolizumab, cisplatin, 5-FU, leucovorin, levoleucovorin
Amgen Inc.AMGN2PHASE3Bemarituzumab, Nivolumab, Chemotherapy, CAPOX, SOX
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY7PHASE2Pumitamig, Folfox, Capox, Nivolumab, BMS-986340
Pfizer Inc.PFE7PHASE2tucatinib, trastuzumab, oxaliplatin, leucovorin, fluorouracil
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel, LY4337713
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography /Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab, Cabozantinib, Durvalumab, Tremelimumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed /m2, Cisplatin /m2
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab, S095029
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06921928primaryCompletionDate: changed
LOWMay 24, 2026NCT06921928studyFirstPostDate: changed