Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Rare Diseases

Melanoma

Carcinoma, Non-Small-Cell Lung

Thyroid Diseases

Lung Neoplasms

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

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Herbal and Botanical

Growth Inhibitors

Cola

Dose escalation of KIN-2787 and binimetinib

Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787

Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib

KIN-2787 will be administered orally twice daily in 28-day cycles

KIN-2787

KIN-2787 and binimetinib will be administered orally twice daily in 28-day cycles

KIN-2787 and binimetinib

Kinnate Clinical Operations

Julia Appelt, CCRC

Jessica Crocker

Bartosz Chmielowski, MD

Debjani Ghoshal

Chris Chen, MD

Sajeve Thomas, MD

Cody Likens

Hao Xie, MD, PhD

CT.gov@nyulangone.org

Janice Mehnert, MD

Michael Offin

Michael Offin, MD

TaussigResearch@ccf.org

Dale Shepard, MD, PhD

Carrie Friedman, RN, BSN, OCN

Michael Millward, Professor

Antonie Italiano

Antonie Italiano, MD

Philippe Cassier

Philippe Cassier, MD

Caroline Gaudy

Stephanie Bordenave

Stephanie Bordenave, MD

David Planchard, MD

Eva Muñoz

Eva Muñoz, MD

María María González Cao, MD

Delvys Rodríguez

Delvys Rodríguez, MD

Antonio Calles Blanco, MD

Valentina Gambardella, MD

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

This is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with BRAF mutation-positive and/or NRAS mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a RAF small molecule kinase inhibitor, to determine a recommended Phase 2 dose (RP2D) of KIN-2787, and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor.

The dose expansion phase (Part B) will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers that contain BRAF Class I, II or III mutations, including lung cancer, melanoma, and other selected solid tumors.

A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants With BRAF and/or NRAS Mutation-positive Solid Tumors.

To determine the safety and tolerability of oral administration of KIN-2787 including dose-limiting toxicities (DLTs), and to identify the maximum tolerated dose (MTD) and/or the appropriate dose for further clinical investigation in Part B Dose Expansion.

To determine the safety and tolerability of oral administration of KIN-2787 + binimetinib including DLTs, and to identify the MTD and/or the appropriate dose for further clinical investigation.

To assess preliminary evidence of the anti-cancer activity of KIN-2787 and for (B2) KIN-2787 + binimetinib

Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression

Pierre Fabre Medicament

Mitogens

BGB-3245

MapKure

The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory solid tumors

Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors

A First-in-Human, Phase 1a/1b, Open Label, Dose-Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of the RAF Dimer Inhibitor BGB-3245 in Patients With Advanced or Refractory Tumors

The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33%.

The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33%

MapKure, LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors	NCT04913285	Solid Tumor, Ad... Non-small Cell ... Melanoma	KIN-2787 KIN-2787 and bi...	18 Years -	Pierre Fabre Medicament
Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or Refractory Tumors	NCT04249843	Solid Tumor B-Raf Mutation-...	BGB-3245	18 Years -	MapKure, LLC

Spots Global Cancer Trial Database for braf class ii