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AGEN1884 + AGEN2034

Phase 1

Cervical Cancer | Small molecule | Oncology |Agenus Inc.|Last Updated: Jul 5, 2023

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment154
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03495882Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)PHASE1 COMPLETED 154Dec 18, 2017Jul 15, 2022Jul 5, 202347 United States, Australia +7
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR), as determined by IERC, in the analysis population
Evaluated throughout the protocol, up to 2 years.

per RECIST 1.1

Secondary Endpoints
Safety and Tolerability of AGEN2034 and AGEN1884
From the time of the first dose to the end of follow-up (up to 2 years after the last dose).
Maximum drug concentration observed postdose at steady-state (Cmax-ss)
Pre-dose through 3 months after last dose.
Minimum observed concentration at steady-state (Cmin-ss)
Pre-dose through 3 months after last dose.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AGEN1884 + AGEN2034EXPERIMENTALAGEN1884 in combination with AGEN2034 in subjects with Subjects with Metastatic or Locally Advanced Solid Tumors, and Expansion into Select Solid Tumors (cervical)
Interventions
NameTypeDescription
AGEN1884 + AGEN2034DRUGAGEN1884 + AGEN2034 according to protocol design
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: To be eligible for participation in this trial the subject must: 1. Voluntarily agree to participate by giving written informed consent. (Participation in pharmacogenomics testing is optional.) 2. Be ≥18 years of age. 3. Diagnosis: 1. Phase 1: Male or female having a histol...

Countries:United StatesAustraliaBrazilGeorgiaHungaryMoldovaPolandSpainUkraine
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Competitive Landscape -Cervical Cancer 68 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN5PHASE3Volrustomig, Cisplatin, Carboplatin, Paclitaxel, 5-FU
Merck & Co., Inc.MRK4PHASE3Sacituzumab Tirumotecan, Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine
Pfizer Inc.PFE3PHASE2tucatinib, trastuzumab, fulvestrant, TG4001, Avelumab
ImmunityBio IncIBRX2PHASE2N-803 + Pembrolizumab, IBRX-042
Eli Lilly and CompanyLLY3PHASE1LY4101174, LY4052031, LY4170156, bevacizumab, carboplatin
MacroGenics, Inc.MGNX2PHASE2Lorigerlimab, MGC026 Dose Escalation
Precigen IncPGEN1PHASE2PRGN-2009 plus Pembrolizumab
Xencor, Inc.XNCR1PHASE2vudalimab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA3PHASE2E7 TCR-T cells, Aldesleukin, KK-LC-1 TCR-T cells
Bristol-Myers Squibb CompanyBMY1PHASE1BMS-986340, BMS-936558-01, Docetaxel, Pumitamig
AbbVie, Inc.ABBV1PHASE1IMGN151
Arcus Biosciences, Inc.RCUS1PHASE1AB598, Zimberelimab, Fluorouracil, Leucovorin, Oxaliplatin
Ascendis Pharma A/SASND1PHASE1TransCon IL-2 β/γ, Pembrolizumab, Chemotherapy drug, TransCon TLR7/8 Agonist, Trastuzumab
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3, Nivolumab, Pembrolizumab
TScan Therapeutics, Inc.TCRX2PHASE1TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101
Oncolytics Biotech Inc.ONCY1PHASE1Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen
Adlai Nortye Ltd. Sponsored ADRANL1PHASE1AN0025, Pembrolizumab
Nurix Therapeutics, Inc.NRIX1PHASE1NX-1607, Paclitaxel
Boundless Bio Inc.BOLD1PHASE1BBI-355, Erlotinib, Futibatinib, BBI-825
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