Delving into the Latest Updates on DN-022150 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DN 022150, DN022150

Target

KRAS G12D

Action

inhibitors

Mechanism

KRAS G12D inhibitors(GTPase KRas G12D inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Pancreatic CancerKRAS G12D mutation Solid TumorsKRAS G12D mutation pancreatic cancer

Inactive Indication-

Originator Organization

Piistech

Active Organization

Jiangxi Kerui Pharmaceutical Co. Ltd.

Inactive Organization

Piistech

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation.The study consists of two stages I, Stage I ：explores the combination dose and the second phase; Stage II ：patients were randomized 1:1 to receive either the experimental regimen DN022150 plus AG or the control regimen AG alone.

Start Date06 Jun 2027

Sponsor / Collaborator

Jiangxi Kerui Pharmaceutical Co. Ltd.

NCT07689539

/ Not yet recruitingPhase 3

A Phase 3, Multicenter, Open-Label, Randomized, Controlled Trial of DN022150 Monotherapy Versus Investigator's Choice Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation

This study plans to enroll participants with previously treated advanced pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. Eligible participants will be randomized 1:1 to DN022150 Monotherapy or Investigator's Choice Chemotherapy

Start Date01 Sep 2026

Sponsor / Collaborator

Jiangxi Kerui Pharmaceutical Co. Ltd.

ChiCTR2400088951

/ RecruitingPhase 1/2IIT

Phase I/IIa Study evaluating the safety, tolerability, pharmacokinetics, and efficacy of DN022150 in patients with advanced solid tumors Harboring KRASG12D mutation

Start Date03 Sep 2024

Sponsor / Collaborator

Zhongshan Hospital Fudan University

100 Clinical Results associated with DN-022150

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100 Translational Medicine associated with DN-022150

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100 Patents (Medical) associated with DN-022150

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100 Deals associated with DN-022150

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	-	Jiangxi Kerui Pharmaceutical Co. Ltd.	01 Sep 2026
KRAS G12D mutation Solid Tumors	Phase 2	China	Jiangxi Kerui Pharmaceutical Co. Ltd.	30 Aug 2024
KRAS G12D mutation pancreatic cancer	IND Approval	China	Jiangxi Kerui Pharmaceutical Co. Ltd.	22 Apr 2026
Neoplasms	IND Application	China	Piistech	19 Jul 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20242749 (ASCO2026)	Phase 1/2	KRAS G12D mutation Solid Tumors KRAS G12D	56	DN022150 (advanced KRAS G12D-mutant solid tumors)	txicpxznuo(uzjxrofvgl) = arrwhbfqob nilybupshi (toolkhpsuw ) View more	Positive	29 May 2026