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PRS-344/S095012

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

PRS-344/S095012 · 1 trial · 1 indication

Phase 1 1
NCT05159388A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid TumorsSolid Tumor
COMPLETED45 Analytics
PHASE1COMPLETED
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
Solid TumorUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about PRS-344/S095012

What is PRS-344/S095012 used for?

PRS-344/S095012 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development and has been studied in a completed trial involving patients with solid tumors.

What does PRS-344/S095012 target?

PRS-344/S095012 is a PD-L1x4-1BB bispecific antibody-Anticalin fusion protein. It targets PD-L1 and 4-1BB, which are proteins involved in immune regulation. The drug is designed to modulate these targets to potentially treat solid tumors.

Who makes PRS-344/S095012?

PRS-344/S095012 is being developed by Tango Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TNGX.

What phase is PRS-344/S095012 in?

PRS-344/S095012 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and efficacy in patients with solid tumors.

What clinical trials is PRS-344/S095012 in?

PRS-344/S095012 has been studied in a Phase 1 clinical trial with the identifier NCT05159388. This trial, titled 'A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors,' enrolled 45 participants and has been completed. The trial was conducted in the United States, Australia, Belgium, and Spain.

Is PRS-344/S095012 the same as S095012?

Yes, PRS-344/S095012 is also known as S095012. The drug is a PD-L1x4-1BB bispecific antibody-Anticalin fusion protein being developed for solid tumors. It is currently in Phase 1 clinical development.