Breast Cancer Clinical Trial

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Solid Tumor Malignancies

Summary

This clinical trial is evaluating a drug called BT8009 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency.

The main goals of this study are to:

Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with nivolumab
Learn more about the side effects and effectiveness of BT8009 alone and in combination with nivolumab
Learn more about BT8009 alone and in combination with nivolumab
Learn more about BT8009 alone in patients with kidney disease

View Full Description

Full Description

BT8009 consists of a bicyclic peptide (Bicycle®) which binds selectively to Nectin-4 covalently attached to a spacer and a val-cit cleavable linker attached to a cytotoxin (MMAE).

This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent in 3 different dosing schedules- weekly (28 day cycle), biweekly (28 day cycle) , dosing on day 1 and day 8 of a 3-weekly cycle and in combination with pembrolizumab. There are three parts to this study. Part A is a dose escalation in patients with select advanced solid tumors primarily designed to evaluate safety and tolerability of BT8009 as monotherapy or in combination with pembrolizumab and to determine a recommended Phase II dose (RP2D). Following a selection of an RP2D, part B, a dose expansion portion, will be initiated with the primary objective of clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab in patients with select advanced solid tumors. Part C will evaluate safety and tolerability of RP2D in patients with renal insufficiency.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria

Life expectancy ≥12 weeks.
Patients must have measurable disease per RECIST 1.1.

Part A-1 cohorts:

Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample must be submitted); or
Patients with advanced, histologically confirmed pancreatic, breast, non-small-cell lung cancer (NSCLC), gastric, esophageal, head and neck, or ovarian tumors that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample testing for Nectin-4 expression).

Part A-2:

Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that recurred after or has been refractory to prior therapy
Cohort B-1: Histologically documented urothelial carcinoma, previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
Cohort B-2 and B-3: Histologically documented urothelial carcinoma, not previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
Cohort B-4: Histologically confirmed non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria that recurred after or has been refractory to prior therapy.
Cohort B-5: Breast cancers that have been confirmed negative for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) (i.e., triple-negative) that have recurred after or has been refractory to prior therapy.
Cohort B-6: Histologically confirmed non-small cell lung cancer (NSCLC) with no actionable mutations, such as Epidermal Growth Factor Receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion oncogene, or ROS1 that recurred after or has been refractory to prior therapy.
Cohort B-7: Locally advanced or metastatic, histologically confirmed urothelial (transitional cell) carcinoma, ineligible for cisplatin, no prior systemic anticancer treatment for advanced urothelial carcinoma.
Cohort C renal insufficiency cohort: Patients with histologically documented urothelial carcinoma that recurred after or has been refractory to prior therapy.

Key Exclusion Criteria (all patients):

Clinically relevant troponin elevation
Uncontrolled diabetes
Uncontrolled, symptomatic brain metastases
Patients with uncontrolled hypertension
History of another malignancy within 3 years before first dose of BT8009 or residual disease from a previously diagnosed malignancy (with some exceptions).
Active systemic infection requiring therapy, or fever within the last 14 days prior to first dose of BT8009.
Prior Stevens-Johnson syndrome/toxic epidermal necrolysis on any MMAE-conjugated drug

Parts A-2 and B-7 Pembrolizumab Combination Cohorts:

Prior organ transplant (including allogeneic)
Diagnosis of clinically relevant immunodeficiency
History of interstitial lung disease
Parts B-2 and B-3: Prior treatment with enfortumab vedotin

Other protocol-defined Inclusion/Exclusion criteria may apply

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

329

Study ID:

NCT04561362

Recruitment Status:

Recruiting

Sponsor:

BicycleTx Limited

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There are 21 Locations for this study

See Locations Near You

Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States More Info
Gerald Falchook, MD
Principal Investigator
Ocala Oncology Center
Ocala Florida, 34474, United States More Info
Rama Balaraman, MD
Principal Investigator
Horizon Oncology Research
Lafayette Indiana, 47905, United States More Info
Costantine Albany, MD
Principal Investigator
Norton Cancer Institute, Downtown
Louisville Kentucky, 40202, United States More Info
Jaspreet Singh Grewal, MD, PhD, MPH
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Jason Robert Brown, MD, PhD
Principal Investigator
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States More Info
Sarah W. Gordon, DO
Principal Investigator
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States More Info
Meredith McKean, MD, MPH
Contact
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jordi Rodon Ahnert, MD, PhD
Principal Investigator
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada More Info
Quincy Siu Chung Chu, MD
Principal Investigator
Princess Margaret Cancer Centre
Toronto Ontario, M5G I, Canada More Info
Aaron R. Hansen, MD
Principal Investigator
Institut Bergonie
Bordeaux , 33076, France More Info
Antoine Italiano, MD, PhD
Principal Investigator
Centre Leon Berard
Lyon , 69373, France More Info
Loic Verligue, MD
Principal Investigator
Institut Gustave Roussy
Villejuif , 94805, France More Info
Capucine Baldini, MD
Principal Investigator
Ospedale San Raffaele
Milan , 20132, Italy More Info
Andrea Necchi, MD
Principal Investigator
Vall d'Hebron Institute of Oncology
Barcelona , 08035, Spain More Info
Irene Brana, MD, PhD
Principal Investigator
Hospital Clinic de Barcelona
Barcelona , 08036, Spain More Info
Oscar Reig, MD
Principal Investigator
START Madrid Fundacion Jimenez Diaz
Madrid , 28040, Spain More Info
Bernard Doger, MD, PhD
Principal Investigator
Next Oncology - Hospital Quironsalud Madrid
Madrid , 28223, Spain More Info
Valentina Boni, MD
Principal Investigator
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom More Info
Hendrik-Tobias Arkenau, MD
Principal Investigator
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom More Info
Louise Carter, MBBS, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

329

Study ID:

NCT04561362

Recruitment Status:

Recruiting

Sponsor:


BicycleTx Limited

How clear is this clinincal trial information?

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