Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Channel Blockers

Herbal and Botanical

Tislelizumab

Trametinib

Dabrafenib

Spartalizumab

Gallopamil

Naporafenib

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Immune Checkpoint Inhibitors

Cola

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.

LTT462

LXH254

TNO155

Liquid in vial (Concentrate for solution for infusion) for intravenous use

Novartis Pharmaceuticals

A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.

This is a phase Ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic BRAF V600 (E, D, or K) in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. The open platform design of this study is adaptive to allow removal of combination treatment arm(s) based on emerging data and facilitate introduction of new candidate combinations. The study is comprised of a dose escalation part and may be followed by a dose expansion part for any combination treatment arm.

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer

To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies

To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies

To characterize the PK of each investigational drug within each treatment arm

To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.

To evaluate PD effect in their respective combinations in tumor

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Amino Acids

Gefitinib

Nazartinib

Tyrosine Kinase Inhibitors

Tyrosine

EGF816 + INC280 in expansion phase (patients with no known resistance mechanism)

EGF816 + LXH254 in expansion phase (patients with no known resistance mechanism)

EGF816 + LXH254 in expansion phase (patients with known resistance mechanism)

EGF816 + INC280 in expansion phase (patients with known resistance mechanism)

EGF816

trametinib

ribociclib

INC280

gefitinib

The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced EGFR-mutant NSCLC.

This is a Phase Ib, open label, non-randomized dose escalation study of EGF816 in combination with ribociclib, trametinib, or LXH254, followed by dose expansion of EGF816 in combination with ribociclib, trametinib, LXH254, INC280, or gefitinib in adult patients with advanced EGFR-mutant NSCLC.

During the dose escalation part, patients will be assigned to the addition of trametinib, ribociclib, or LXH254 to EGF816.

Following determination of the recommended dose for the combination of EGF816 + trametinib, EGF816 + ribociclib, and EGF816 + LXH254, patients may be enrolled to the dose expansion arms of each of these combinations. Patients may also be assigned to EGF816 + INC280 or EGF816 + gefitinib in dose expansion.

Efficacy assessments will be performed at baseline and every 2 cycles during treatment.

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

A Phase Ib, Open Label, Multi-center Study to Characterize the Safety, Tolerability and Preliminary Efficacy of EGF816 in Combination With Selected Targeted Agents in EGFR Mutant NSCLC

Assess safety and tolerability including incidence of dose limiting toxicities, adverse events, and serious adverse events.

Modified objective response rate (ORR2) per RECIST v1.1 (taking as baseline the most recent assessment prior to initiating combination)

Overall response rate (ORR) per RECIST v1.1

Time from the date of first dose of study treatment to the date of first documented disease progression (per RECIST v1.1) or death due to any cause

Proportion of patients with best overall response of CR, PR, or SD

Time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Melanoma

Ovarian Cancer

Ovarian Epithelial Cancer

Antibodies

Immunoglobulins

PDR001

A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway Alterations.

Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations

A Phase I Dose Finding Study of Oral LXH254 in Adult Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations

Symptoms and General Pathology

Adenocarcinoma

Neoplasm Metastasis

Adenocarcinoma of Lung

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Lung Adenocarcinoma

Neuroendocrine Tumor

Neuroepithelioma

LXH254 will be supplied as tablet for oral use.

LTT462 will be supplied as hard gelatin capsule for oral use.

Trametinib will be supplied as film-coated tablet for oral use

Ribociclib will be supplied in tablets and hard gelatin capsules.

Ribociclib

To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.

A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer	NCT04294160	BRAF V600 Color...	Dabrafenib LTT462 Trametinib LXH254 TNO155 Spartalizumab Tislelizumab	18 Years -	Novartis
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC	NCT03333343	EGFR-mutant Non...	EGF816 trametinib ribociclib LXH254 INC280 gefitinib	18 Years -	Novartis
Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations	NCT02607813	NSCLC Ovarian Cancer Melanoma Other Solid Tum...	LXH254 PDR001	18 Years -	Novartis
A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma	NCT02974725	Non-Small Cell ... Melanoma	LXH254 LTT462 Trametinib Ribociclib	18 Years -	Novartis
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC	NCT03333343	EGFR-mutant Non...	EGF816 trametinib ribociclib LXH254 INC280 gefitinib	18 Years -	Novartis
A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma	NCT02974725	Non-Small Cell ... Melanoma	LXH254 LTT462 Trametinib Ribociclib	18 Years -	Novartis

Spots Global Cancer Trial Database for lxh254

Every month we try and update this database with for lxh254 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lxh254

Every month we try and update this database with for lxh254 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lxh254 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.