Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

After progression, subjects will crossover to combination therapy

Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle

Apalutamide

Carotuximab administered intravenously at the following doses:

Cycle 1 Day 1: 3 mg/kg Cycle 1 Day 4: 7 mg/kg Cycle 1 Day 8: 10 mg/kg Cycle 1 Day 15: 10 mg/kg Cycle 1 Day 22: 10 mg/kg Cycle 2 Day 1: 15 mg/kg Cycle 2 Day 15: 15 mg/kg Cycle 3+ Day 1: 15 mg/kg After completion of cycle 2, dosing of carotuximab will continue at a q4 week schedule using the 15 mg/kg dose.

Carotuximab

Clinical Trial Recruitment Navigator

Robert Figlin, MD FACP

Jun Gong, MD

Kevin Scher, MD MBA

David Hoffman, MD

Leland Green, MD

Kristopher Wentzel, MD

Edwin Posadas, MD FACP

This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.

Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.

Grade 3 or above treatment related adverse events as assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Participants of the combination of apalutamide + carotuximab, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3

Participants of the monotherapy group that crossover to combination therapy at progression, with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1 and Prostate Cancer Working Group 3

Determined by confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3

From the start of study treatment until documented progression, per Prostate Cancer Working Group 3, or death due to any cause.

Enviro Therapeutics, Inc.

Edwin Posadas, MD

Co-Director, Experimental Therapeutics Program

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Osimertinib given by mouth daily at 40mg or 80mg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.

Carotuximab is administered intravenously weekly for the first 4 weeks, then every 2 weeks at 10mg/kg or 15 mg/kg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance.

Karen Reckamp, MD, MS

The purpose of this study is to examine the combination of osimertinib and carotuximab to assess the safety and find the recommended dose for treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC). Safety and tolerability will be measured by the number of dose-limiting toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of objective response rate, duration of response, progression-free survival, and disease control rate, along with assessing biomarkers through tumor tissue and circulating tumor DNA.

Single arm phase I dose escalation study with expansion cohorts.

1. Part I: Progressive disease on at least one prior EGFR TKI
2. Part II, Cohort 1: Progressive disease on osimertinib or other prior EGFR TKIs
3. Part II, Cohort 2: Receiving osimertinib as front line treatment for less than 12 weeks. Persistent ctDNA with EGFR mutation between weeks 6-12 from the start of osimertinib treatment.

Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

IIT2021-12-Reckamp-Osi105: Phase I Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer

The number of adverse events are graded by NCI CTCAE v5.0. The number of these dose-limiting toxicities (DLTs) experienced within the first treatment cycle (28 days) will be assessed to determine the RP2D.

Proportion of participants with confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

Proportion of participants with confirmed CR, PR, or stable disease (SD) per RECIST v.1.1

Length of time from treatment response to progressive disease (PD) per RECIST v.1.1or death.

From Cycle 1 Day 1 (C1D1) until first documentation of PD per RECIST v.1.1 or death due to any cause.

ctDNA will be evaluated for genomic alterations.

ctDNA will be evaluated to correlate with response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer	NCT05534646	Castration-resi...	Apalutamide Carotuximab	18 Years -	Cedars-Sinai Medical Center
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer	NCT05534646	Castration-resi...	Apalutamide Carotuximab	18 Years -	Cedars-Sinai Medical Center
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer	NCT05534646	Castration-resi...	Apalutamide Carotuximab	18 Years -	Cedars-Sinai Medical Center
Study of Osimertinib With Carotuximab in Advanced, EGFR-mutated Non-Small Cell Lung Cancer	NCT05401110	Non Small Cell ... Lung Cancer	Osimertinib Carotuximab	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for carotuximab

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

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