Nav1.7 blockers(Sodium channel protein type IX alpha subunit blockers), mTORC1 inhibitors(Mammalian target of Rapamycin (mTORC1) inhibitors), mTORC2 inhibitors(mTOR Complex 2 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Breast Cancer

Inactive Indication

Metastatic Solid TumorNeoplasm Metastasis

Originator Organization

Boehringer Ingelheim GmbH

Active Organization

Xynomic Pharmaceuticals, Inc.

Inactive Organization

Boehringer Ingelheim GmbH

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Clinical Trials associated with XP-105

NCT01938846 / CompletedPhase 1

An Open Label Phase I Dose Finding Study of BI 860585 Administered Orally in a Continuous Dosing Schedule as Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumours

The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI 860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs, patients are entered sequentially into escalating dose cohorts. Secondary objectives are objective response and disease control according to RECIST criteria version 1.1

Start Date05 Sep 2013

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with XP-105

100 Translational Medicine associated with XP-105

100 Patents (Medical) associated with XP-105

Literatures (Medical) associated with XP-105

CancersQ2 · MEDICINE

A Phase 1 Study of mTORC1/2 Inhibitor BI 860585 as a Single Agent or with Exemestane or Paclitaxel in Patients with Advanced Solid Tumors

Q2 · MEDICINE

ArticleOA

Author: Braunger, Juergen ; Tiseo, Marcello ; Rascher, Juliane ; Dermine, Alexandre ; Salvagni, Stefania ; Damian, Silvia ; Cresta, Sara ; de Braud, Filippo ; Boggiani, Daniela ; Mariani, Gabriella L ; Machiels, Jean-Pascal H ; Laruelle, Marie ; Fischer, Daniela ; Hoefler, Josef ; Lapeire, Lore D F ; Rottey, Sylvie W H ; Duca, Matteo ; Ould-Kaci, Mahmoud

This phase 1 trial (NCT01938846) determined the maximum tolerated dose (MTD) of the mTOR serine/threonine kinase inhibitor, BI 860585, as monotherapy and with exemestane or paclitaxel in patients with advanced solid tumors. This 3+3 dose-escalation study assessed BI 860585 monotherapy (5–300 mg/day; Arm A), BI 860585 (40–220 mg/day; Arm B) with 25 mg/day exemestane, and BI 860585 (80–220 mg/day; Arm C) with 60–80 mg/m2/week paclitaxel, in 28-day cycles. Primary endpoints were the number of patients with dose-limiting toxicities (DLTs) in cycle 1 and the MTD. Forty-one, 25, and 24 patients were treated (Arms A, B, and C). DLTs were observed in four (rash (n = 2), elevated alanine aminotransferase/aspartate aminotransferase, diarrhea), four (rash (n = 3), stomatitis, and increased gamma-glutamyl transferase), and two (diarrhea, increased blood creatine phosphokinase) patients in cycle 1. The BI 860585 MTD was 220 mg/day (Arm A) and 160 mg/day (Arms B and C). Nine patients achieved an objective response (Arm B: Four partial responses (PRs); Arm C: Four PRs; one complete response). The disease control rate was 20%, 28%, and 58% (Arms A, B, and C). The most frequent treatment-related adverse events (AEs) were hyperglycemia (54%) and diarrhea (39%) (Arm A); diarrhea (40%) and stomatitis (40%) (Arm B); fatigue (58%) and diarrhea (58%) (Arm C). The MTD was determined in all arms. Antitumor activity was observed with BI 860585 monotherapy and in combination with exemestane or paclitaxel.

100 Deals associated with XP-105

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 2	CN	Xynomic Pharmaceuticals, Inc.	30 Jan 2022
Metastatic Solid Tumor	Phase 2	IT	Boehringer Ingelheim GmbH	05 Sep 2013
Metastatic Solid Tumor	Phase 2	BE	Boehringer Ingelheim GmbH	05 Sep 2013
Neoplasm Metastasis	Phase 2	BE	Boehringer Ingelheim GmbH	05 Sep 2013
Neoplasm Metastasis	Phase 2	IT	Boehringer Ingelheim GmbH	05 Sep 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01938846 (ASCO2019)	Phase 1	HR-positive/HER2-low Solid Tumors	90	XP-105 monotherapy	(ygvtapoodn) = 50% (XP-105/paclitaxel combination) kuqburjnnq (mmcsgcznma ) View more	-	26 May 2019
NCT01938846 (ASCO2019)	Phase 1	HR-positive/HER2-low Solid Tumors	90	XP-105 + exemestane		-	26 May 2019
NCT01938846 (ASCO2016)	Phase 1	HR-positive/HER2-low Solid Tumors	82	BI 860585 monotherapy	vxjysnbzpn(hhpmjfqjoo) = 1 pt in Arm A pimghamflb (cbvmmweuti ) View more	-	20 May 2016

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