Delving into the Latest Updates on Dilpacimab with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

Dilpacimab (USAN/INN), Immunoglobulin, anti-(notch ligand dll4/vascular endothelial growth factor) (synthetic human pr-1283233 heavy chain), disulfide with synthetic human pr-1283233 light chain, dimer

+ [1]

Target

DLL4 x VEGF-A

Action

inhibitors

Mechanism

DLL4 inhibitors(Delta-like protein 4 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication-

Inactive Indication

Advanced Malignant Solid NeoplasmMetastatic Colorectal Carcinoma

Originator Organization

AbbVie, Inc.

Active Organization-

Inactive Organization

AbbVie, Inc.

License Organization-

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 9550454H

Source: *****

Sequence Code 9550442L

Source: *****

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.

Start Date08 Aug 2013

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Dilpacimab

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100 Translational Medicine associated with Dilpacimab

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100 Patents (Medical) associated with Dilpacimab

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5

Literatures (Medical) associated with Dilpacimab

01 Sep 2022·Future Oncology

Efficacy and Safety of Dilpacimab (ABT-165) versus Bevacizumab Plus Folfiri in Metastatic Colorectal Cancer: A Phase II Study

Article

Author: Naumovski, Louie ; Strickler, John H ; Blaney, Martha ; Cubillo, Antonio ; Lowe, Thomas ; Kozloff, Mark ; Wainberg, Zev A ; Liang, Jin-Tung ; Matrana, Marc ; Sahtout, Mohammad

Aim: This phase II study investigated safety and efficacy of dilpacimab or bevacizumab plus FOLFIRI in patients with previously treated metastatic colorectal cancer (mCRC). Materials & methods: Overall, 66 patients were treated (n = 34 dilpacimab + FOLFIRI; n = 32 bevacizumab + FOLFIRI). Progression-free survival, overall survival, response rates and tolerability were assessed. Results: Median progression-free survival for dilpacimab + FOLFIRI compared with bevacizumab + FOLFIRI was 3.78 months (95% CI: 2.07–7.20) versus 7.36 months (95% CI: 5.68–10.55) (hazard ratio: 3.57; 95% CI: 1.57–8.11; stratified). Median overall survival: 7.95 months for dilpacimab + FOLFIRI; not reached for bevacizumab + FOLFIRI. Objective response rates: 5.6% for dilpacimab + FOLFIRI and 14.7% for bevacizumab + FOLFIRI. Patients treated with dilpacimab + FOLFIRI experienced serious treatment-related adverse events (n = 4; 11.8%), including one case of intestinal perforation leading to death; none were reported for bevacizumab + FOLFIRI. Conclusion: Treatment with dilpacimab + FOLFIRI was not well tolerated and did not provide clinical benefit to patients with mCRC compared with bevacizumab + FOLFIRI. Clinical Trial Registration: NCT03368859 ( Clinicaltrials.gov )

01 Oct 2021·Molecular Cancer TherapeuticsQ2 · MEDICINE

Phase I Open-Label Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Dilpacimab in Patients with Advanced Solid Tumors

Q2 · MEDICINE

Article

Author: Barve, Minal ; Blaney, Martha ; Nemunaitis, John ; Sledge, George W. ; Motwani, Monica ; Ramanathan, Ramesh K. ; Wang, Lan ; Wainberg, Zev A. ; Yue, Huibin ; Naumovski, Louie ; Strickler, John H. ; Hamilton, Erika P. ; Kasichayanula, Sreeneeranj ; Gordon, Michael S. ; Morgan-Lappe, Susan E.

AbstractDilpacimab (formerly ABT-165), a novel dual-variable domain immunoglobulin, targets both delta-like ligand 4 (DLL4) and VEGF pathways. Here, we present safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data from a phase I study (trial registration ID: NCT01946074) of dilpacimab in patients with advanced solid tumors. Eligible patients (≥18 years) received dilpacimab intravenously on days 1 and 15 in 28-day cycles at escalating dose levels (range, 1.25–7.5 mg/kg) until progressive disease or unacceptable toxicity. As of August 2018, 55 patients with solid tumors were enrolled in the dilpacimab monotherapy dose-escalation and dose-expansion cohorts. The most common treatment-related adverse events (TRAE) included hypertension (60.0%), headache (30.9%), and fatigue (21.8%). A TRAE of special interest was gastrointestinal perforation, occurring in 2 patients (3.6%; 1 with ovarian and 1 with prostate cancer) and resulting in 1 death. The PK of dilpacimab showed a half-life ranging from 4.9 to 9.5 days, and biomarker analysis demonstrated that the drug bound to both VEGF and DLL4 targets. The recommended phase II dose for dilpacimab monotherapy was established as 3.75 mg/kg, primarily on the basis of tolerability through multiple cycles. A partial response was achieved in 10.9% of patients (including 4 of 16 patients with ovarian cancer). The remaining patients had either stable disease (52.7%), progressive disease (23.6%), or were deemed unevaluable (12.7%). These results demonstrate that dilpacimab monotherapy has an acceptable safety profile, with clinical activity observed in patients with advanced solid tumors.

01 Jun 2018·Annals of Oncology

ABT-165 plus FOLFIRI vs bevacizumab plus FOLFIRI in patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine/oxaliplatin and bevacizumab - Trial in progress

Article

Author: Blaney, M ; Naumovski, L ; Kasichayanula, S ; Motwani, M ; Yue, H ; Wainberg, Z ; Strickler, J ; Wang, L

100 Deals associated with Dilpacimab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11642	-	-	DB16140

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 2	South Korea	AbbVie, Inc.	20 Mar 2018
Metastatic Colorectal Carcinoma	Phase 2	Belgium	AbbVie, Inc.	20 Mar 2018
Metastatic Colorectal Carcinoma	Phase 2	United States	AbbVie, Inc.	20 Mar 2018
Metastatic Colorectal Carcinoma	Phase 2	Taiwan Province	AbbVie, Inc.	20 Mar 2018
Metastatic Colorectal Carcinoma	Phase 2	Canada	AbbVie, Inc.	20 Mar 2018
Metastatic Colorectal Carcinoma	Phase 2	Spain	AbbVie, Inc.	20 Mar 2018
Advanced Malignant Solid Neoplasm	Phase 2	United States	AbbVie, Inc.	08 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03368859 (Pubmed)	Phase 2	Metastatic Colorectal Carcinoma	66	Dilpacimab + FOLFIRI	aefkwwkcqh(zaxehuzygu) = Patients treated with dilpacimab + FOLFIRI experienced serious treatment-related adverse events (n = 4; 11.8%), including one case of intestinal perforation leading to death; none were reported for bevacizumab + FOLFIRI. xwqbnapcxs (ybntjzegqs ) View more	Negative	03 Aug 2022
NCT03368859 (Pubmed)	Phase 2	Metastatic Colorectal Carcinoma	66	Bevacizumab + FOLFIRI		Negative	03 Aug 2022
NCT01946074 (Pubmed \| Mol Cancer Ther) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	55	Dilpacimab	(fyrmqtrqwp) = qszqizcnnr uavbnqsmzx (gjbuqwzokv ) View more	Positive	01 Oct 2021
NCT03368859 (Phase 1b open-label study, CTgov)	Phase 2	Metastatic Colorectal Carcinoma	70	ABT-165+Leucovorin+irinotecan+Fluorouracil - bolus (ABT-165 Plus FOLFIRI)	(hbnkhwjtks) = tsidodtiqn gljlahqdfk (brrrugxhck, nxmhccnoih - jcrkxqghad) View more	-	09 Feb 2021
NCT03368859 (Phase 1b open-label study, CTgov)	Phase 2	Metastatic Colorectal Carcinoma	70	Leucovorin+Bevacizumab+irinotecan+Fluorouracil - bolus (Bevacizumab Plus FOLFIRI)	(hbnkhwjtks) = iabphgpaim gljlahqdfk (brrrugxhck, hmngqjhrcw - bzscopxqum) View more	-	09 Feb 2021
NCT03368859 (Phase 1b open-label study, ESMO_GI2018)	Phase 1	Colorectal Cancer Second line KRAS mutation status	16	ABT-165 2.5 mg/kg plus FOLFIRI	(zlpovamejf) = ikruexgwtn mjociojmzo (jpctpieqhg ) View more	Positive	20 Jun 2018
NCT01946074 (ASCO2016)	Phase 1	HR-positive/HER2-low Solid Tumors	54	ABT-165	gpzihjyoqx(iypdjslfnw) = Other AEs of interest with respect to mechanism of action included ... gastrointestinal perforation (GIP) (3.7%) jpieomwbfi (epblfmcmnx ) View more	Positive	20 May 2016

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Biosimilar

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