Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antibodies

Androgens

Immunoglobulins

Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will be enrolled into escalating dose levels during the Dose Escalation period of the study.

Eligible patients will receive FOR46 administered as an IV infusion every 21 days. Patients will receive the maximum tolerated dose during the Dose Expansion period of the study.

FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46

FOR46

Andrew Dorr, MD

This study will test the safety and efficacy of FOR46 given every 21 days to patients with metastatic castration-resistant prostate cancer.

The name of the study drug involved in this study is: FOR46 for Injection (FOR46)

This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46 in patients with metastatic castration-resistant prostate cancer. This study will be conducted in two parts:

Dose escalation:

This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once this dose is shown to be safe, a second patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD is reached.

Dose expansion:

This part of the study will further evaluate the safety, tolerability and antitumor activity of FOR46 at a dose shown to be safe in the dose escalation part of the study. Patients will be enrolled into 1 of 2 groups, based on histology.

Following completion of the dose escalation phase of the study and determination of a recommended phase 2 dose, patients will be enrolled into a dose expansion cohort.

A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Association between level of tumor expression of CD46 by immunohistochemistry (IHC) analysis with clinical outcomes

Type, incidence, severity, seriousness, and relatedness of adverse events.

The severity and incidence of dose-limiting toxicities related to escalating dose levels of FOR46

Decline in serum prostate-specific antigen greater than 50% from baseline, confirmed by repeat measurement and objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST)

FOR46 area under the plasma concentration-time curve

Change from baseline in serum levels of antidrug antibodies

Assessed by Prostate Cancer Clinical Trials Working Group 3 criteria

Fortis Therapeutics, Inc.

Immunoglobulins, Intravenous

Immunoconjugates

Immunologic Factors

Approximately 3 dose levels of FOR46 will be evaluated. Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) will also be administered on Day 2 during all treatment cycles

Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1, at the maximum tolerated dose (MTD) as determined in Phase 1b. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) will also be administered on Day 2 during all treatment cycles.

Enzalutamide

Pegfilgrastim

UCSF Genitourinary Medical Oncology

Rahul Aggarwal, MD

This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.

PRIMARY OBJECTIVES:

Phase 1b:

I. To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of FOR46 in combination with enzalutamide in patients with mCRPC.

Phase 2:

I. To determine the composite response rate of FOR46 plus enzalutamide, defined as:

1. Decline in serum PSA \>= 50% (PSA50) from baseline, confirmed by repeat measurement at least 4 weeks later, and/or
2. Objective response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

SECONDARY OBJECTIVES:

Phase 1b and Phase 2:

I. To determine the PSA50 response rate.

II. To determine the objective response rate by RECIST 1.1 criteria among patients with measurable soft tissue by RECIST 1.1 criteria at baseline.

III. To determine the median duration of objective response.

IIII. To determine the median time to prostate-specific antigen (PSA) progression by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.

V. To determine the median radiographic progression-free survival by PCWG3 criteria.

VI. To determine the median overall survival.

VII. To determine the safety of the combination.

Participants may continue study treatment from the time of treatment initiation until confirmed radiographic disease progression per PCWG3 / RECIST 1.1 criteria, unequivocal clinical progression, unacceptable toxicity, or patient withdrawal, whichever occurs first. Patients will be followed for overall survival every 90 days (+/- 30 days) from last dose of study treatment, until death, withdrawal of consent, or the end of the study, whichever occurs first.

FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 1b/2 Study of FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer

A minimum of 3 patients will be treated at each dose level. If \< 33%of patients (i.e. 0 of 3 patients, or 1 of 6 patients) within a cohort have a dose-limiting toxicity (DLT in Cycle 1, then enrollment of the next cohort may commence upon approval of Data and Safety Monitoring Committee. At any dose level, dose escalation will be discontinued if \>= 2 of 3 to 6 patients within a cohort experience a DLT in Cycle 1, the MTD will have been exceeded. The previous dose level will then be considered the MTD if 6 patients were previously evaluated at this dose level. If this dose level was previously evaluated with 3 patients, then 3 additional patients will be enrolled at this dose level; if 0 or 1 of the additional 3 patients experiences a DLT in Cycle 1, then this dose level will be considered the MTD.

Dose-limiting toxicities classified using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0will be tabulated by dose level and reported in descriptive fashion.

Composite response is defined as a \>= 50% decline from baseline PSA (defined by Cycle 1 Day 1 value), confirmed by repeat measurement \>= 4 weeks later AND/OR objective tumor response by RECIST 1.1 criteria The composite response rate along with 95% confidence interval will be reported

PSA50 response is defined as above, a ≥ 50% decline from baseline in serum PSA, confirmed by repeat measurement ≥ 4 weeks later. The PSA50 response proportion will be reported along with 95% confidence interval for each study cohort, for the subset of PSA-evaluable patients (serum PSA ≥ 2 ng/mL at baseline)

The objective response rate and median duration of response will be reported along with 95% confidence interval for the subset of patients with measurable soft tissue disease by RECIST 1.1 criteria at baseline

The median duration of response will be reported along with 95% confidence interval for the subset of patients with measurable soft tissue disease by RECIST 1.1 criteria at baseline

Median time to PSA progression assessed by PCWG3 criteria will be determined from the date of first dose of protocol-defined therapy, using Kaplan-Meier product limit method. Patients who discontinue treatment for reasons other than adverse event, patient withdrawal, etc. will be censored by the date of last treatment.

Median radiographic progression-free survival assessed by PCWG3 criteria will be determined from the date of first dose of protocol-defined therapy, using Kaplan-Meier product limit method. Patients who discontinue treatment for reasons other than adverse event, patient withdrawal, etc. will be censored by the date of last treatment.

The median overall survival along with 95% confidence interval will be determined from the date of first dose of protocol-defined therapy until death from any cause, using the Kaplan-Meier product limit method. Patients will be followed for long-term survival as outlined in the Study Procedures. Patients who withdraw from study will be censored for analysis of overall survival using the date of study withdrawal.

Adverse events will be recorded and severity graded using CTCAE version 5.0. The frequency and highest grade of severity of adverse events will be descriptively reported

Rahul Aggarwal

Principal Investigator

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma.

The name of the study drug involved in this study is: FOR46 for Injection

This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46 in patients with relapsed or refractory multiple myeloma. This study will be conducted in two parts:

Dose escalation:

This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once this dose is shown to be safe, a second patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD is reached.

Dose expansion:

This part of the study will further evaluate the safety, tolerability and antitumor activity of FOR46 at a dose shown to be safe in the dose escalation part of the study.

A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

Number of patients with treatment-related adverse events as assessed by NCI CTCAE v5.0.

Overall response rate of FOR46, defined as all responses greater than or equal to a partial response, complete response, stringent complete response, or minimal residual disease negativity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Study of FOR46 in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)	NCT03575819	Prostate Cancer...	FOR46	18 Years -	Fortis Therapeutics, Inc.
FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer	NCT05011188	Metastatic Cast... Prostate Cancer	FOR46 Enzalutamide Pegfilgrastim	18 Years -	University of California, San Francisco
A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)	NCT03650491	Multiple Myelom... Multiple Myelom... Multiple Myelom...	FOR46	18 Years -	Fortis Therapeutics, Inc.

Spots Global Cancer Trial Database for for46

Every month we try and update this database with for for46 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 for46

Every month we try and update this database with for for46 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 for46 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.