Recent Updates
Recently added Catalysts

nuzefatide pevedotin

Phase 2

Pancreatic Ductal Adenocarcinoma (PDAC) | Small molecule | Oncology |Bicycle Therapeutics plc|Last Updated: Apr 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07450859A Study of Nuzefatide Pevedotin (BT5528) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)PHASE2 RECRUITING 39Mar 5, 2026May 1, 2029Apr 22, 20261 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
Up to approximately 3 years

Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator

Secondary Endpoints
Duration of Response (DoR) per RECIST v1.1
Up to approximately 3 years
Overall Survival (OS)
Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1
Up to approximately 3 years
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
nuzefatide pevedotin (BT5528) MonotherapyEXPERIMENTAL -
Interventions
NameTypeDescription
nuzefatide pevedotin (BT5528)DRUGParticipants will receive nuzefatide pevedotin (BT5528) via intravenous (IV) infusion every 2 weeks (Q2W)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * At least 18 years of age at the time of signature of the informed consent form * Measurable disease as defined by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Histologically confirmed metastatic pa...

Countries:United States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07450859primaryCompletionDate: changed
LOWMay 24, 2026NCT07450859studyFirstPostDate: changed