Breast Cancer Clinical Trial

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced 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

This study will assess the safety and tolerability of BT8009 alone and in combination with pembrolizumab in patients with select advanced solid tumors. BT8009 will be given as a single agent in 3 different dosing schedules- weekly (28 day cycle), biweekly (28 day cycle) or dosing on day 1 and day 8 of a 3-weekly (21 day 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. Part D will further characterize the pharmacokinetics of BT8009 and MMAE.

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 have progressed following 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: Patients with 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 have progressed following prior therapy.
Cohort B-5: Patients with triple-negative breast cancer 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 progressed following prior therapy.
Cohort B-6: Patients with 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 have progressed following 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, ovarian, triple negative breast, or non-small cell lung cancer that have been previously treated with a locally approved therapy.

Key Exclusion Criteria (all patients):

Clinically relevant troponin elevation
Uncontrolled diabetes
Known active or untreated CNS and/or carcinomatous meningitis
Grade ≥2 peripheral neuropathy
Active keratitis or corneal ulcerations
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 29 Locations for this study

See Locations Near You

Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Advent Health
Orlando Florida, 34747, United States
Horizon Oncology Research
Lafayette Indiana, 47905, United States
Norton Cancer Institute, Downtown
Louisville Kentucky, 40207, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Mary Crowley Cancer Research Center
Dallas Texas, 75230, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto Ontario, M5G I, Canada
Institut Bergonie
Bordeaux , 33076, France
Centre Leon Berard
Lyon , 69373, France
Institut Paoli-Calmettes
Marseille , 13009, France
Centre Eugene Marquis
Rennes , 35042, France
Institut Gustave Roussy
Villejuif , 94805, France
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano MI, 20133, Italy
Ospedale San Raffaele
Milan , 20132, Italy
Vall d'Hebron Institute of Oncology
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
START Madrid Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Next Oncology - Hospital Quironsalud Madrid
Pozuelo de Alarcon , 28223, Spain
Hospital Universitario Marques de Valdecilla
Santander , 39008, Spain
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

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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