Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Antibodies

Antibodies, Bispecific

Immunoglobulins

Mitogens

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

In Part 1 dose escalation, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached, or all planned doses are administered.

In Part 2 dose expansion, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28 at the recommended phase II dose (RP2D) regimen. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity.

EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).

EMB-01

Osimertinib is an approved, third-generation EGFR tyrosine kinase inhibitor

Xiaodong Sun, MD

Di Hu

Misako Nagasaka

Julia Kathleen Rotow

Yi-Long Wu

This phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer. EMB-01 in combination with osimertinib may work better in treating patients with EGFR-mutant advanced non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To evaluate the maximum tolerated dose (MTD) and to establish the recommended phase II dose (RP2D) of EMB-01 given in combination with osimertinib in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). (Phase Ib)

II. To preliminarily assess efficacy and further evaluate the safety and tolerability of EMB-01 plus osimertinib at the RP2D in advanced EGFR-mutant NSCLC patients who progressed on prior EGFR tyrosine kinase inhibitor (TKI) treatment. The primary endpoint is objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase II)

SECONDARY OBJECTIVES:

I. To assess the pharmacokinetics (PK) of EMB-01 and osimertinib.

II. To assess the immunogenicity of EMB-01 and osimertinib.

III. To evaluate preliminary antitumor activity of EMB-01 and osimertinib. (Phase I)

IV. To continue to evaluate the antitumor activity of EMB-01 and osimertinib such as progression free survival, best overall response, duration of response, and clinical benefit rate. (Phase II)

EXPLORATORY OBJECTIVES:

I. To explore the relationships between pharmacokinetics, biomarkers, adverse event profiles, and anticancer activity of EMB-01 combined with osimertinib.

OUTLINE: This is a phase Ib, dose-escalation study of EMB-01 and osimertinib followed by a phase II study.

Patients receive EMB-01 intravenously (IV) weekly. Patients also receive osimertinib orally (PO) once daily (QD) on days 1-28. Treatment cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer

A Phase Ib/II, Open-Label, Multi-Center Study of EMB-01 in Combination With Osimertinib in Patients With Advanced/Metastatic EGFR Mutant Lung Cancer

Adverse events and serious adverse events as assessed by CTCAE v5.0

Objective response rate, measured by RECIST 1.1

Best overall response as assessed by RECIST v1.1

Duration of response as assessed by RECIST v1.1

Clinical benefit rate as assessed by RECIST v1.1

Progression free survival as assessed by RECIST v1.1

Maximum measured plasma concentration of EMB-01

Blood samples will be collected from patients post-treatment for assessment of the presence of anti-drug antibodies and neutralizing antibodies.

Labcorp Corporation of America Holdings, Inc

Shanghai EpimAb Biotherapeutics Co., Ltd.

Digestive System Diseases

Adenocarcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Colorectal Neoplasms

Head and Neck Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antibodies, Monoclonal

Chelating Agents

Radiopharmaceuticals

The study conducted in two parts: Part A Dose Exploration and Part B Dose Escalation

FPI-2053 dose exploration to determine the optimal pre-dose administration of FPI-2053 with a fixed dose of \[225Ac\]-FPI-2068.

\[225Ac\]-FPI-2068 dose escalation with the optimal dose of FPI-2053 as determined in Part A.

FPI-2053 is a bispecific antibody that targets EGFR and cMET

FPI-2053

\[111In\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053.

Participants will have a fixed dose of \[111In\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053).

[111In]-FPI-2107

\[225Ac\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053.

Participants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period.

[225Ac]-FPI-2068

Clinical Trials Fusion Pharmaceuticals Clinical Operations

David Marcellus

Andrei Iagaru, MD

Aditya Juloori, MD

Veronika Seseri

Heather Jacene, MD

Kristen Harrington

Richard Wahl, MD

John Crandall

Jordi Rodon Ahnert, MD

Yang Lu, MD

Delphine Chen, MD

Heather White

Daniel Juneau, MD

Michel Pavic, MD

Christine Lawson

Éric Turcotte, MD

Lisa Jean-Louis

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).

The study will be conducted in 2 parts:

Part A: optimization of the FPI-2053 dose (treatment with dose level 1 of \[225Ac\]-FPI-2068 - fixed dose).

Part B: dose escalation of \[225Ac\]-FPI-2068 with optimal FPI-2053. Part B will commence once the optimal dose of FPI-2053 is determined in Part A. The RP2D will be determined from Part B based on all available safety, efficacy, PK, and dosimetry information.

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

• Incidence of Adverse Events and evaluation of dosimetry

* For Part A, evaluate the impact of pre-dose administration of FPI-2053 on the radiation dosimetry of \[111In\]-FPI-2107 (whole body, organs, and selected regions of interest)
* Estimate the effect of pre-dose administration of FPI-2053 on the radiation dosimetry of \[225Ac\]-FPI-2068 (whole body, organs, and selected regions of interest)

Determine the RP2D of \[225Ac\]-FPI-2068, given with or without FPI-2053

• Tumour assessments will be based on RECIST v1.1 (Eisenhauer et al, 2009) and will be performed approximately every 8 weeks (± 1 week) after the first \[225Ac\]-FPI-2068 dose, or as clinically indicated.

• Tumor uptake of \[111In\]-FPI-2107 in selected regions of interest on SPECT/CT and/or planar images

• Determine the plasma concentrations and PK parameters of \[111In\]-FPI-2107, and \[225Ac\]-FPI-2068 and the effect of pre-dose administration of FPI-2053 on the plasma concentrations and PK parameters of \[111In\]-FPI-2107.

• Presence of ADA for \[111In\]-FPI-2107, \[225Ac\]-FPI-2068, and FPI-2053

AstraZeneca

Fusion Pharmaceuticals Inc.

Immune System Diseases

Blood and Lymph Conditions

Hypersensitivity

Hematologic Neoplasms

Crizotinib

For adult patients, crizotinib 250 mg BID will be administered orally at approximately the same time each day on a continuous daily dosing schedule, ie, without break in dosing. For pediatric patients, crizotinib 280 mg/m2 BID will be administered orally at approximately the same time each day on a continuous daily dosing schedule, ie, without break in dosing.

Pfizer CT.gov Call Center

This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age \<18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.

Crizotinib is indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Commercially available dosage forms are 250 mg and 200 mg capsules. This expanded access protocol (EAP) is designed to provide access to an alternative oral formulation of crizotinib for those patients who are unable to swallow capsules.

Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

CRIZOTINIB (XALKORI(REGISTERED)) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULES

Pfizer

Symptoms and General Pathology

Neoplasm Metastasis

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Methotrexate

Tepotinib

Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily

Ki Hyeong Lee, M.D.

Eun Joo Kang, M.D.

Soon Il Lee

Yu Jeong Kim

Yun Ji Choe

The aim of this study is to understand efficacy of tepotinib in patients with solid cancers harbouring c-MET amplification or exon 14 mutation who progressed after standard treatment for metastatic disease.

This study is a basket trial with two strata(NSCLC and other cancer). If MET exon 14 skipping mutation or MET amplification(copy number gain ≥6.0 ) is detected by NGS method, then confirmation of genetic findings by Molecular Steering Committee will be followed. Patient can participate in this trial after confirmation of genetic analysis and reviewing other inclusion/exclusion criteria.

Experimental: Arm 1_NSCLC Patients with non-small cell lung cancer (NSCLC) harboring MET alteration Experimental: Arm 2_Other solid tumors Solid tumors excluding NSCLC harboring MET alteration

Tepotinib in Solid Tumors Harboring MET Alterations

A Phase II Study of Tepotinib in Patients With Solid Cancers Harboring c-MET Amplification or Exon 14 Mutation Who Progressed After Standard Treatment for Advanced/Metastatic Disease

Objective response will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator.

Objective response is defined as either a confirmed complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Progression free survival as assessed by investigators is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (based on independent review) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first

Objective disease control is defined as either a confirmed CR or PR, or stable disease (SD) lasting at least 12 weeks (84 days) as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions.

Overall survival is defined as the time (in months) from first trial treatment administration to the date of death.

This outcome measure will be presented as the percentage of subjects with any adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer	NCT05498389	Metastatic Lung... Advanced Lung N... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... EGFR Mutation-R...	EMB-01 Osimertinib	18 Years -	Shanghai EpimAb Biotherapeutics Co., Ltd.
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours	NCT06147037	Advanced Solid ... Metastatic Colo... Head and Neck S... Non-small Cell ... Pancreatic Duct...	FPI-2053 [111In]-FPI-210... [225Ac]-FPI-206...	18 Years -	Fusion Pharmaceuticals Inc.
Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients	NCT02473497	Neoplasm	Crizotinib	0 Years -	Pfizer
Tepotinib in Solid Tumors Harboring MET Alterations	NCT04647838	Solid Tumor MET Exon 14 Ski... MET Amplificati...	Tepotinib	19 Years -	Chungbuk National University Hospital
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer	NCT05498389	Metastatic Lung... Advanced Lung N... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... EGFR Mutation-R...	EMB-01 Osimertinib	18 Years -	Shanghai EpimAb Biotherapeutics Co., Ltd.

Spots Global Cancer Trial Database for cmet

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

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