BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Additional cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

Expansion cohort: BAY1179470 will be administered as a 1-hour intravenous infusion every 21 days.

BAY1179470 will be administered as a 1-hour intravenous infusion.

BAY1179470

Bayer Study Director

An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors

First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors

An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous BAY 1179470 in Subjects With Advanced, Refractory Solid Tumors.

Tumor response will be evaluated based on the RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.

Bayer

Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma

Pemigatinib will be self-administered at 9mg Or 13.5mg as a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule

Pemigatinib

This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy

Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Who Failed at Least One Previous Therapy

Innovent Biologics (Suzhou) Co. Ltd.

Crouzon Syndrome

Jackson-Weiss Syndrome

Pfeiffer Syndrome

All Drugs and Chemicals

Antibodies

Immunoglobulins

Mitogens

Aprutumab ixadotin

Immunoconjugates

Immunologic Factors

Dose-escalation phase:

Approximately 30 subjects will participate in the dose-escalation phase The total number of subjects will depend on the number of cohorts necessary to identify the MTD.

MTD expansion phase:

Once the MTD has been determined, two expansion cohorts in FGFR2 expressing indications are planned:

Cohort 1: Triple negative breast cancer (TNBC). This cohort will enroll 80 subjects (N=40 with low to moderate FGFR2 expression and N=40 with high FGFR2 expression) Cohort 2: Other indications expressing FGFR2. This cohort 40 subjects will be enrolled.

A dose of 0.1 mg BAY 1187982 per kilogram (kg) body weight (BW) was chosen as the starting dose based on toxicology data. The investigational drug will be administered as a 1-hour IV infusion once every 21 days at the trial site (Day 1 of each 21-day Cycle). The maximum possible dose escalation will be 2-fold and not more than 0.5 mg/kg BW until maximum tolerated dose is selected

BAY1187982

To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)

Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

An Open-label,Phase I, Dose-escalation Trial to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Pharmacokinetic, and Pharmacodynamics of the Anti-FGFR2 Antibody Drug Conjugate BAY1187982 in Subjects With Advanced Solid Tumors Known to Express FGFR2.

The MTD is defined as the maximum dose at which the incidence of DLTs during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalation

FGFR2

Man Jiang

Patients were aged \>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).

Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)

The Affiliated Hospital of Qingdao University

Digestive System Diseases

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Hematinics

Antineoplastic Agents

Liver Extracts

Infigratinib

Infigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg.

Infigratinib is a selective ATP-competitive inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that inhibits FGFR downstream signaling and proliferation in human cancer cell lines with FGFR genetic alterations, significantly inhibiting the growth of several types of cancers driven by FGFR amplification, fusion and mutation.

Lei Mu

Yifu He

Mingjun Zhang

Lin Shen

Jiayi Li

Hao Chen

Yifen Wu

Jingtang Chen

Yongjian Zhou

Yanhong Deng

Bihui Li

Jing Li

Zhiyu Wang

Yanqiao Zhang

Hong Zong

Hong Qiu

Huiting Xu

Huaxin Duan

Jia Wei

Ying Cheng

Xiujuan Qu

Enxiao Li

Meili Sun

Zuoxing Niu

Jing Lv

Tianshu Liu

Yusheng Wang

Ming Liu

Jin Lu

Ting Deng

Lin Xie

Haiping Jiang

This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .

Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma

A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification

ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.

DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.

DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.

the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1

the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC

from the first date of Infigratinib treatment until date of death.

LianBio LLC

Liver Neoplasms

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Patients who received derazantinib orally at dose levels from 25 mg every other day (QOD) - 200 mg daily (QD) on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Derazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule.

Derazantinib low dose range

Derazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule.

Derazantinib middle dose range

Derazantinib was administered orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule.

Derazantinib high dose range

Derazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule.

Derazantinib at recommended phase 2 dose (RP2D)

Marc Engelhardt, MD

This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Expanded Cohort, signal finding).

Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations

A Phase 1/2 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma With FGFR2 Gene Fusion

Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE)

The number of patients with an objective tumor response, which included those with either a complete response (CR) or a partial response (PR) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response.

The objective response rate (ORR) was defined as the proportion of patients with a CR or PR.

The number of patients with tumor disease control, which included those with either a complete or partial tumor response, or a stable disease (SD) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response. The disease control rate (DCR) was defined as the proportion of patients with CR, PR or SD.

PFS was calculated as the time from the date of first dose until documented radiographic disease progression or death from any cause, whichever occurred first. Disease progression is measured according to a specified radiologic increase in tumor size.

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Basilea Pharmaceutica

Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group

Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group

Derazantinib 400 mg QOD - 425 mg QD - High Dose Group

Derazantinib 300 mg QD - Expanded Cohort Group

Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Safety Population (patients who received any amount of derazantinib)

Study Director

The safety population included all subjects who received at least one dose of derazantinib.

Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs)

Evaluable Population: patients who received at least one cycle of study treatment and had at least one postbaseline tumor evaluation.

Proportion of Patients With an Objective Tumor Response Per RECIST 1.1

Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria .

Proportion of Patients With Disease Control Per RECIST 1.1

Progression-free Survival (PFS)

Subjects who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Subjects who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Subjects who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Subjects who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors	NCT01881217	Neoplasms	BAY1179470	20 Years -	Bayer
Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement	NCT04256980	Cholangiocarcin...	Pemigatinib	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)	NCT02368951	Medical Oncolog...	BAY1187982	18 Years -	Bayer
Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement	NCT04256980	Cholangiocarcin...	Pemigatinib	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)	NCT04713059	Gastric or Gast... Advanced, Relap... Second-line The...	FGFR2	18 Years - 90 Years	The Affiliated Hospital of Qingdao University
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma	NCT06206278	Gastric Cancer Gastroesophagea...	Infigratinib	18 Years - 99 Years	LianBio LLC
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations	NCT01752920	Solid Tumor	Derazantinib lo... Derazantinib mi... Derazantinib hi... Derazantinib at...	18 Years -	Basilea Pharmaceutica

Spots Global Cancer Trial Database for fgfr2

Every month we try and update this database with for fgfr2 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for fgfr2

Every month we try and update this database with for fgfr2 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 fgfr2 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.