Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

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

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Trametinib

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Approximately 40 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma, ATC)

Approximately 28 subjects with V600 Solid Tumors (non-CNS) (post BRAF inhibitor for NSCLC, CRC, melanoma)

Approximately 30 subjects with V600 melanoma or NSCLC (post BRAF inhibitor)

Approximately 20 subjects with V600 melanoma or NSCLC (post BRAF Inhibitor)

Approximately 30 subjects with CRC (post BRAF inhibitor)

Approximately 40 subjects with CRC (post BRAF inhibitor)

CFT1946

Specified intravenous dose on specified day

Study Medical Officer

The purpose of this study is to evaluate the safety and tolerability of CFT1946 as well as to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CFT1946 as monotherapy (Arm A) and in combination with trametinib (CFT1946 + trametinib; Arm B) or Cetuximab (CFT1946 + cetuximab; Arm C).

A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors

A Phase 1/2 Open-Label Multicenter Trial to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors

Phase 2 only according to RECIST v1.1 criteria

Tumor BRAF-V600 degradation at scheduled timepoints

C4 Therapeutics, Inc.

Gland and Hormone Related Diseases

Thyroid Diseases

Carcinoma

Thyroid Neoplasms

Head and Neck Neoplasms

Thyroid Carcinoma, Anaplastic

Endocrine System Diseases

Endocrine Gland Neoplasms

Neoplasms, Glandular and Epithelial

Anaplastic Thyroid Cancer

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Fosbretabulin

Combretastatin

Tubulin Modulators

Antimitotic Agents

Six 21 day cycles of:

Fosbretabulin (60 mg/m2) IV on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC 6) IV on Day 2

Six 21-day cycles of:

Placebo (formulated and packages to match fosbretabulin)on Day 1, 8, 15 Paclitaxel (200 mg/m2) IV on Day 2 Carboplatin (AUC6) IV on Day 2

Fosbretabulin + paclitaxel + carboplatin

Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion

Placebo + paclitaxel + carboplatin

Marcia Brose, MD, PhD

Julie A Sosa, MD

Lisa Licitra, MD

This is a multicenter, double-blind, placebo-controlled, randomized study of fosbretabulin given with chemotherapy (paclitaxel and carboplatin) compared to placebo given with chemotherapy (paclitaxel and carboplatin) in subjects with anaplastic thyroid cancer (ATC). The primary objective of the study is to determine overall survival. A maximum of 300 subjects will be recruited from approximately 75 multinational sites of which approximately 35 will be located in the United States.

The Treatment Plan followed for all subjects will consist of:

* A Screening Visit within 14 days before study drug (fosbretabulin or placebo) administration
* A Treatment Phase of 21-day combination treatment (study drug plus chemotherapy) cycles (up to 6 cycles)
* An End of Treatment Phase assessment
* An End of Study Visit occurring 30 days after the last day of study drug administration, as able

After the last clinic visit, all subjects will be followed for survival by monthly phone calls, email, or in-person.

Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Fosbretabulin Tromethamine (CA4P) in Combination With Paclitaxel and Carboplatin in Anaplastic Thyroid Carcinoma (FACT2)

Mateon Therapeutics

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

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

HLX208

The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).

The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

An Open Label, Multicenter Phase Ib/II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors	NCT05668585	Solid Tumors Melanoma NSCLC CRC ATC	CFT1946 Trametinib Cetuximab	18 Years -	C4 Therapeutics, Inc.
Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer	NCT01701349	Anaplastic Thyr...	Fosbretabulin +... Placebo + pacli...	18 Years -	Mateon Therapeutics
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
Fosbretabulin or Placebo in Combination With Carboplatin/Paclitaxel in Anaplastic Thyroid Cancer	NCT01701349	Anaplastic Thyr...	Fosbretabulin +... Placebo + pacli...	18 Years -	Mateon Therapeutics
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation	NCT05102292	Anaplastic Thyr... ATC	HLX208	18 Years -	Shanghai Henlius Biotech
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation	NCT05102292	Anaplastic Thyr... ATC	HLX208	18 Years -	Shanghai Henlius Biotech

Spots Global Cancer Trial Database for atc

Every month we try and update this database with for atc 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 atc

Every month we try and update this database with for atc 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 atc 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.