Delving into the Latest Updates on Lu-177-DGUL with Synapse

Overview

Basic Info

Drug Type

Peptide Conjugate Radionuclide, Therapeutic radiopharmaceuticals

Synonyms

177Lu-DOTA-GUL, Lu-177 labelled PSMA-D, PSMA-D GUL

Target

PSMA

Action

modulators

Mechanism

PSMA modulators(Prostate-specific membrane antigen modulators)

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Metastatic castration-resistant prostate cancerProstatic Cancer

Inactive Indication-

Originator Organization

Cellbion Co., Ltd.

Active Organization

Cellbion Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Structure/Sequence

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The goal of this clinical trial is to evaluate the safety of the combination therapy of Lutetium (177Lu) DGUL and pembrolizumab. It will also assess the antitumor efficacy and pharmacokinetics of the combination therapy compared to Lutetium (177Lu) DGUL monotherapy.
Participants will:
Monotherapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals
Combination therapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals along with pembrolizumab up to 18 times at 6-week intervals

Start Date01 Dec 2025

Sponsor / Collaborator

Cellbion Co., Ltd.

[+1]

NCT05547061

/ Active, not recruitingPhase 1/2

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy

This clinical trial is an open-label, single-arm, multi-center, escalation (Phase 1 Part B only), rater-blind (Phase 2 only), phase 1/2 trial to evaluate the diagnostic validity/safety of Ga-68-NGUL and efficacy/safety of Lu-177-DGUL on the anti-tumor activity that aims to simultaneously evaluate diagnostic and therapeutic validity.

Start Date12 Apr 2021

Sponsor / Collaborator

Cellbion Co., Ltd.

IRCT20180113038331N1

/ RecruitingPhase 2IIT

Treatment of castration-resistant metastatic prostate cancer, refractory to routine treatment with Lu177-PSMA

Start Date13 Dec 2017

Sponsor / Collaborator

Mashhad University of Medical Sciences

100 Clinical Results associated with Lu-177-DGUL

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100 Translational Medicine associated with Lu-177-DGUL

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100 Patents (Medical) associated with Lu-177-DGUL

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100 Deals associated with Lu-177-DGUL

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	South Korea	Cellbion Co., Ltd.	12 Apr 2021
Prostatic Cancer	Phase 1	United States	Cellbion Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05547061 (ASCO_GU2026)	Phase 2	Metastatic castration-resistant prostate cancer PSMA-positive	91	Lu-177-DGUL	sdlpxdfjbp(cfmuwpkaio) = sbjhogbicc nkgxayoarc (huzqxrhpxa ) View more	Positive	26 Feb 2026
				Lu-177-DGUL (pre-taxane patients)	sdlpxdfjbp(cfmuwpkaio) = jauutaqqai nkgxayoarc (huzqxrhpxa )
SNMMI2023	Phase 1/2	Metastatic castration-resistant prostate cancer PSMA-positive PET scan	28	177Lu-DGUL 5.55 GBq	dgovqummfb(mksfufrglv) = no severe adverse drug reactions were observed dkzbjdgyft (rscsehtmrc ) View more	Positive	28 Aug 2023
				177Lu-DGUL 7.40 GBq