Cohort F/FF for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carolina BioOncology Institute, Huntersville, NC
Breast Cancer+6 More
Avelumab - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1 dose-finding study of FT536 monotherapy and in combination with monoclonal antibodies.

Eligible Conditions

  • Breast Cancer
  • Colorectal Carcinoma (CRC)
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Head and Neck Cancer
  • GastroEsophageal Cancer
  • Ovarian Cancer
  • Malignant Neoplasm of Pancreas

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Following dose escalation and dose expansion within each cohort, approximately 3 years

Year 3
Define recommended phase 2 dose (RP2D)
Year 3
Incidence, nature, and severity of adverse events (AEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Cohort F/FF
1 of 6
Cohort B/BB
1 of 6
Cohort D/DD
1 of 6
Cohort E/EE
1 of 6
Cohort A/AA
1 of 6
Cohort C/CC
1 of 6
Experimental Treatment

322 Total Participants · 6 Treatment Groups

Primary Treatment: Cohort F/FF · No Placebo Group · Phase 1

Cohort F/FFExperimental Group · 5 Interventions: Amivantamab, Cyclophosphamide, Fludarabine, IL-2, FT536 · Intervention Types: CombinationProduct, Drug, Drug, Drug, Drug
Cohort B/BBExperimental Group · 5 Interventions: Avelumab, Cyclophosphamide, Fludarabine, IL-2, FT536 · Intervention Types: CombinationProduct, Drug, Drug, Drug, Drug
Cohort D/DDExperimental Group · 5 Interventions: Trastuzumab, Cyclophosphamide, Fludarabine, IL-2, FT536 · Intervention Types: CombinationProduct, Drug, Drug, Drug, Drug
Cohort E/EEExperimental Group · 5 Interventions: Cetuximab, Cyclophosphamide, Fludarabine, IL-2, FT536 · Intervention Types: CombinationProduct, Drug, Drug, Drug, Drug
Cohort A/AAExperimental Group · 4 Interventions: Cyclophosphamide, Fludarabine, IL-2, FT536 · Intervention Types: Drug, Drug, Drug, Drug
Cohort C/CCExperimental Group · 7 Interventions: Pembrolizumab, Nivolumab, Atezolizumab, Cyclophosphamide, Fludarabine, IL-2, FT536 · Intervention Types: CombinationProduct, CombinationProduct, CombinationProduct, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 3
~3030
Cetuximab
2011
Completed Phase 3
~2610
Pembrolizumab
2017
Completed Phase 3
~2950
Nivolumab
2014
Completed Phase 3
~5540
Atezolizumab
2015
Completed Phase 4
~6340
Trastuzumab
2014
Completed Phase 4
~9050
Cyclophosphamide
1995
Completed Phase 3
~4020
Fludarabine
2012
Completed Phase 2
~1240
IL-2
2007
Completed Phase 4
~1150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: following dose escalation and dose expansion within each cohort, approximately 3 years
Closest Location: Carolina BioOncology Institute · Huntersville, NC
2012First Recorded Clinical Trial
9 TrialsResearching Breast Cancer
15 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects with NSCLC, HNSCC, gastroesophageal adenocarinoma, triple negative breast cancer, or urothelial carcinoma whose tumors express PD-L1 according to defined cutoff.
Subjects with advanced solid tumor whose tumor(s) express HER2 defined as: ≥2+ by IHC, Average HER2 copy number ≥4 signals per cell by in situ hybridization or ≥4 copies as determined by next generation sequencing.
You must be aged 18 years or greater.
You have measurable disease per RECIST v1.1.
You are willing to undergo tumor biopsy.
You are using a method of contraception that is approved for use in the protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.