Recent Updates
Recently added Catalysts

Lutetium DGUL

Phase 1

Metastatic Castration-resistant Prostate Cancer (mCRPC) | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Nov 24, 2025

Target and mechanism

Molecular targetSSTR5, SSTR2, SSTR4, SSTR1, SSTR3
Target classBinding Agent
ModalitySmall molecule

Also known as Lutetium (177Lu) DGUL

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Lutetium DGUL · 1 trial · 1 indication

Phase 1 1
NCT07244393Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate CancerMetastatic Castration-resistant Prostate Cancer (mCRPC)
NOT YET_RECRUITING30 Analytics
PHASE1NOT YET_RECRUITING
Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-resistant Prostate Cancer (mCRPC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients with treatment-emergent adverse events (TEAEs)
From enrollment to 6-month follow-up after the end of treatment
Number of patients with drug-related TEAEs
From enrollment to 6-month follow-up after the end of treatment
Adverse events (AEs)
From enrollment to 6-month follow-up after the end of treatment
Drug-related adverse reactions based on dose limited toxicity (DLT) definitions
From enrollment to 6-month follow-up after the end of treatment

Secondary Endpoints

Radiographic progression-free survivla (rPFS)
From enrollment to 6-month follow-up after the end of treatment
1-year overall survivla (OS)
From enrollment to 6-month follow-up after the end of treatment
Objective response rate (ORR; confirmed complete response (CR) + partial response (PR))
From enrollment to 6-month follow-up after the end of treatment
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monotherapy ArmEXPERIMENTALMonotherapy Arm: 10 patients will receive Lutetium (177Lu) DGUL monotherapy.
Combination ArmEXPERIMENTALCombination Arm: 20 patients will receive Lutetium (177Lu) DGUL in combination with pembrolizumab.

Interventions

NameTypeDescription
Lutetium (177Lu) DGULDRUGLutetium (177Lu) DGUL will be administered in 4 doses at 6-week intervals (Q6W), and for patients showing good tolerance, additional 2 doses may be added, for a maximum of 6 doses.
PembrolizumabDRUGPembrolizumab will be introduced at a dose of 400 mg every 6 weeks, beginning with the second cycle of Lutetium (177Lu) DGUL, and will continue for up to approximately 2 years (18 doses).
Unlock Study Design Details

Eligibility Criteria

Age Range19 Years to N/A
SexMALE
Healthy VolunteersNo

Inclusion Criteria: * Male patients aged 19 years or older. * Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, without neuroendocrine or small cell differentiation, who have metastatic disease documented by bone lesions/soft tissue lesions and are not eli...

Unlock Eligibility Criteria

Frequently asked questions about Lutetium DGUL

What is Lutetium DGUL used for?

Lutetium DGUL is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It is a radioligand therapy that delivers radiation to cancer cells. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does Lutetium DGUL target?

Lutetium DGUL is a radioligand therapy that uses the radioactive isotope lutetium-177. While the specific molecular target is not disclosed, the drug is designed to bind to prostate cancer cells and deliver targeted radiation. It is being evaluated in combination with pembrolizumab in patients with metastatic castration-resistant prostate cancer.

Who makes Lutetium DGUL?

Lutetium DGUL is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic castration-resistant prostate cancer.

What phase is Lutetium DGUL in?

Lutetium DGUL is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of the drug in combination with pembrolizumab.

What clinical trials is Lutetium DGUL in?

Lutetium DGUL is being studied in a Phase 1 clinical trial with the identifier NCT07244393. The trial, titled 'Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer,' is not yet recruiting and aims to enroll 30 male patients aged 19 years and older.

Is Lutetium DGUL the same as Lutetium (177Lu) DGUL?

Yes, Lutetium DGUL is also known as Lutetium (177Lu) DGUL. The alternative name specifies the radioactive isotope lutetium-177 used in the drug's composition. Both names refer to the same investigational compound being developed by Merck for metastatic castration-resistant prostate cancer.