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PRS-344/S095012

Phase 1

Solid Tumor | Small molecule | Oncology |Tango Therapeutics, Inc.|Last Updated: Jul 8, 2025

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 Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05159388A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid TumorsPHASE1 COMPLETED 45Sep 8, 2021Apr 8, 2025Jul 8, 202511 United States, Australia +2
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Study Endpoints
Primary Endpoints
Safety measurements
28 days

Phase 1: Incidence of dose-limiting toxicities (DLTs) over the first 28-days of study treatment

Objective Response (OR)
Through study completion up to 24 months

Phase 2: Defined as Complete Response (CR) plus Partial Response (PR). For arms 1 and 2, per central assessment according to RECIST v1.1 criteria. For Arm 3, per central assessment and composite response criteria (digital medical photography and/or imaging as per RECIST v1.1)

Secondary Endpoints
Mean PRS-344/S095012 concentrations at the end of the infusion
Through study completion up to 24 months
Mean PRS-344/S095012 trough concentrations (Ctrough)
Through study completion up to 24 months
Detection of anti-drug antibodies (ADA) against PRS-344/S095012
Through study completion up to 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRS-344/S095012EXPERIMENTALPRS-344/S095012
Interventions
NameTypeDescription
PRS-344/S095012DRUGPRS-344/S095012 Monotherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Age ≥18 years on the day the consent is signed. 2. Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated. 3. Patient should hav...

Countries:United StatesAustraliaBelgiumSpain
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