Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Urinary Bladder Neoplasms

Disease Attributes

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bemarituzumab

Antineoplastic Agents, Immunological

Bemarituzumab administration every two weeks

FPA144

This is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer

This protocol is intended to provide access to bemarituzumab (FPA144 an investigational agent) to a single patient with recurrent bladder cancer who had a response to study drug on FPA144-001. That study is closing and this expanded access protocol allows this single patient to continue receiving this agent.

An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer

Five Prime Therapeutics, Inc.

Digestive System Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Esophageal Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Esophageal Cancer

Transitional Cell Carcinoma

Dose escalation of FPA144 (0.3 mg/kg to 15 mg/kg)

Dose escalation of FPA144 (3-10 mg/kg) in patients with gastric cancer

Evaluation of objective responses in patients with tumors with various levels of FGFR2b overexpression

FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.

Medical Lead

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.

Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.

Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors

Deidentified data will be provided to investigative sites requesting information for secondary publication.

Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)

Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)

Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.

• Summary of area under serum concentration-time curve, maximum serum concentration,

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Duration of complete or partial response with 95% confidence intervals in gastric cancer population.

3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.

Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg

3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.

Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg

3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.

Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg

3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.

Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg

3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.

Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg

3 + 3 dose escalation cohort with 15mg/kg FPA144 IV every 2 weeks in 28 day cycles.

Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles

Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles

Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles

Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg

Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.

Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors

Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg

3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles..

Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg

Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg

3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.

Part 1B: FPA144 Dose Escalation Gastric 6 mg/kg

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 15 mg/kg IV every 2 weeks in 28 day cycles.

Part 1B: FPA144 Dose Escalation Gastric 10 mg/kg

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

South Korea

United States

Taiwan

Region of Enrollment

All eligible patients enrolled on the study who had baseline characteristics measured in each arm and overall.

Inclusion of patients with refractory gastric cancer with short duration of drug exposure may have limited our ability to accurately evaluate the incidence of off-target effects adverse events in the study population, in particular corneal toxicity.

Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.

Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).

3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles..

Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)

Phase 1a Dose Escalation 0.3 mg/kg

Phase 1a Dose Escalation 1 mg/kg

Phase 1a Dose Escalation 3 mg/kg

Phase 1a Dose Escalation 6 mg/kg

Phase 1a Dose Escalation 10 mg/kg

Phase 1a Dose Escalation 15 mg/kg

Phase 1b Dose Escalation in Gastric Cancer 3 mg/kg

Phase 1b Dose Escalation in Gastric Cancer 6 mg/kg

Phase 1b Dose Escalation in Gastric Cancer 10 mg/kg

All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.

Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration

Part 1B: FPA144 Dose Escalation Gastric Cancer 6mg/kg

Part 1B: FPA144 Dose Escalation Gastric Cancer 10mg/kg

Patients with various levels of FGFR2b overexpression in tumor samples treated with bemarituzumab who had baseline and post baseline scans performed.

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Part 1/2: FPA144 Dose Expansion Gastric or Other Solid Tumors

Gastric cancer patients with various levels of FGFR2b overexpression treated with FPA144 who had an objective response.

Duration of Response Per RECIST 1.1 (Part 2 Only)

Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve

A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 1.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.

Part 1A: FPA144 Dose Escalation Solid Tumors 1mg/kg

A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 3.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.

A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.

A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.

A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 15 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.

Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.

Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.

Overall Study

Participants will receive escalating doses of FPA144. On completion of Cycle 1 (Cycles = 28 days in length) participants may participate in an optional Extended Treatment Period based on the Investigator's discretion, which begins on Day 1 of Cycle 2. FPA144 will be administered once every 2 weeks (Q2W) in 4-week cycles until disease progression, or until the patient meets any of the other withdrawal criteria.

FPA144 will be administered intravenously Q2W.

The main objectives of this study are:

* To determine the recommended dose (RD) of FPA144 in participants with gastric or gastroesophageal cancer (hereafter referred to as gastric cancer)
* To evaluate the safety of escalating doses of FPA144 in participants with gastric cancer
* To characterize the pharmacokinetic (PK) profile of single and multiple doses of intravenously administered FPA144 in participants with gastric cancer

A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer

A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

DLTs are defined as specific adverse events (AEs) or clinically laboratory abnormalities that occur during the DLT observation period (Day 1 to Day 28 of Cycle 1; cycle = 28 days), that the Cohort Review Committee (CRC) assess as related to FPA144. Events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:

* Grade 3: Severe or medically significant but non-immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE
* Grade 4: Life-threatening consequences; urgent intervention indicated

TEAEs will be graded using the NCI CTCAE version 4.03. Any clinically significant laboratory abnormalities will also be reported as TEAEs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer	NCT03801278	Recurrent Bladd...	FPA144	18 Years -	Five Prime Therapeutics, Inc.
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer	NCT03801278	Recurrent Bladd...	FPA144	18 Years -	Five Prime Therapeutics, Inc.
Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors	NCT02318329	Advanced Solid ... Gastric Cancer Transitional Ce...	FPA144	18 Years -	Five Prime Therapeutics, Inc.
Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors	NCT02318329	Advanced Solid ... Gastric Cancer Transitional Ce...	FPA144	18 Years -	Five Prime Therapeutics, Inc.
A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer	NCT05913115	Gastric or Gast...	FPA144	18 Years -	Amgen

Spots Global Cancer Trial Database for fpa144

Every month we try and update this database with for fpa144 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 fpa144

Every month we try and update this database with for fpa144 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 fpa144 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.