Recent Updates
Recently added Catalysts

GEN-001

Phase 2

Gastric Cancer | Small molecule | Oncology |Merck KGaA|Trials Updated: Dec 16, 2025

GEN-001 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Oct 2001

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment53

FDA Designations

No designations recorded

GEN-001 clinical trials

GEN-001 · 2 trials · 6 indications

Phase 2 1Phase 1 1
NCT05419362GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric CancerGastric Cancer
COMPLETED42 Analytics
PHASE2COMPLETED
GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer
Gastric Cancer
NCT0541936242
Unlock trial analytics

Study Endpoints

Primary Endpoints

To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab
1 years

Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Dose Escalation: Incidence of Adverse Events
1 years

Assessed as per CTCAE v5.0

Dose Escalation: Incidence of Laboratory abnormalities
1 years

Assessed as per CTCAE v5.0

Dose Escalation: Incidence of dose-limiting toxicity (DLT)
1 Cycle (one cycle = 28 days)

To evaluate the safety and tolerability of GEN-001 in combination with avelumab

Dose Expansion: To assess objective response (OR) of GEN-001 in patients with advanced or metastatic solid tumors, when administered as combined with avelumab.
2 years

Confirmed OR per RECIST v1.1 by the Investigator

Secondary Endpoints

Incidence of Adverse Events
1 years
Incidence of Laboratory abnormalities
1 years
Duration of response (DoR)
1 years
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GEN-001 with avelumabEXPERIMENTAL42 patients in total with metastatic GC/Gastroesophageal Junction Adenocarcinoma who have progressed after 2 prior systemic treatments and confirmed PD-L1 positive expression will be enrolled in this study.

Interventions

NameTypeDescription
GEN-001DRUGThe capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)
AvelumabDRUG800 mg given by intravenous (IV) infusion once every 2 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range19 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Histologically confirmed unresectable, recurrent, locally advanced or metastatic GC/Gastroesophageal Junction Adenocarcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have adequate organ functions as defined in the protocol * Negative childbear...

Countries:South KoreaUnited States
Unlock Eligibility Criteria

Competitive Landscape -Gastric Cancer 158 trials

Top 20 of 47 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN17PHASE3AZD0901, Sonesitatug Vedotin, Rilvegostomig, Trastuzumab deruxtecan, Durvalumab
Jazz Pharmaceuticals Public Limited CompanyJAZZ4PHASE3Zanidatamab
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, BGB-B2033, BG-68501, BGB-43395
Bristol-Myers Squibb CompanyBMY8PHASE2Pumitamig, Nivolumab, Nab-paclitaxel, BMS-986340
Pfizer Inc.PFE7PHASE2Disitamab vedotin, Tucatinib, Trastuzumab, PF-08634404, PF-08046050
Merck & Co., Inc.MRK7PHASE3Pembrolizumab, Patritumab Deruxtecan
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, AGEN2034
AbbVie, Inc.ABBV3PHASE2Telisotuzumab Adizutecan, Budigalimab, ABBV-253, Azirkitug
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, LY4337713
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009
ImmunityBio IncIBRX1PHASE2Nogapendekin alfa inbakicept
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079
Apollomics Inc. Class AAPLM1PHASE2APL-101
Gilead Sciences, Inc.GILD2PHASE2Denikitug
Exelixis, Inc.EXEL2PHASE1Cabozantinib
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106
Arcus Biosciences, Inc.RCUS1PHASE1AB598, Zimberelimab
NovaBridge Biosciences Sponsored ADRNBP2PHASE2Givastomig
Incyte CorporationINCY1PHASE2Retifanlimab
Unlock Competitive Intelligence

Explore more on BiopharmaWatch

Merck KGaA (MKGAF)Pipeline, catalysts, financials, insiders and newsGastric Cancer disease mapEvery company developing for Gastric Cancer, by stage and capitalFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with GCompanies A to ZEvery biotech and pharma company we track