Breast Cancer Clinical Trial

Study of MT-5111 in HER2-positive Solid Tumors

Summary

This will be a Phase 1b, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) given as monotherapy in subjects with HER2-positive solid tumors

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Full Description

This study will be conducted in two parts:

Part A (Dose Escalation): The purpose of Part A is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Part A will include any type of HER2-positive solid cancer.

Part B (Dose Expansion): The purpose of Part B is to confirm the safety and tolerability of MT-5111 doses selected from those explored in Part A including the MTD or RP2D. Part B will include 3 types of HER2-positive solid cancers in the following 3 expansion groups: Group B1: Breast cancer; Group B2: gastric or gastroesophageal adenocarcinomas (GEA); and Group B3: Other HER2-positive solid cancers.

The Breast Cancer cohort will start enrolling in parallel to Part A.

Up to 178 eligible subjects will be identified and treated through competitive enrollment at multiple study centers globally

In Parts A and B of the study, a subject may participate for the following four periods:

Screening (up to 28 days before first dose of MT-5111)

Treatment period (active period where a subject will receive three weekly doses of MT-5111 over a 21-day treatment cycle)

Short-term Follow-up (30 days after last dose of MT-5111)

Long-term follow-up (up to 24 months after the last dose of MT-5111)

MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle, a cycle being defined as 21 days). A subject can continue receiving MT-5111 as long as it is well-tolerated, their disease has not worsened, or until the subject decides they no longer want to participate in the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:

Part A (Dose-Escalation): All HER2-positive solid cancers are eligible
Part B (Dose-Expansion): Any type of HER2-positive solid cancer, including breast cancer, and gastric or gastroesophageal adenocarcinomas (GEA).
HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a metastatic lesion in cases of metastatic cancers).
Relapsed or refractory to or intolerant of existing therapy(ies)
At least 1 measurable or evaluable lesion according to RECIST 1.1 (Subjects with evaluable disease only may be included in the dose escalation phase)
ECOG performance score of ≤ 1

Adequate Bone marrow function as determined by:

Absolute neutrophil count (ANC) ≥ 1,000/mm3
Platelet count ≥ 75,000 mm³ and
Hemoglobin ≥ 8.0 g/dL
Red blood cell transfusion within 2 weeks of study treatment start is allowed if hemoglobin levels remain stable

Kidney function:

Creatinine clearance (CLcr) ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula

Cardiac Function:

Left ventricular ejection fraction (LVEF) ≥ 55% on the echocardiogram (ECHO) assessment (preferred), or multigated acquisition (MUGA) scan, and QTcF ≤ 480 ms for women and QTcF ≤ 450 ms for men [average from three QTcF values on the triplicate 12-lead electrocardiogram (ECG)] at baseline

Hepatic function:

Total bilirubin ≤ 1.5 x ULN, or ≤ 3 x ULN for subjects with Gilbert's Syndrome and
AST ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis) and ALT ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis)

Exclusion Criteria:

History or current evidence of another tumor that is histologically distinct from the tumor under study

Current evidence of new or growing CNS metastases during screening

Subjects with known CNS metastases will be eligible if they meet protocol specified criteria
Evidence of CTCAE Grade >1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria
History or evidence of significant cardiovascular disease
Current evidence of active, uncontrolled hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) (evidenced by detectable viral load by PCR) or acquired immunodeficiency syndrome (AIDS) related illness
Current evidence of ≥ grade 2 underlying pulmonary disease
Certain exclusionary prior treatments

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

178

Study ID:

NCT04029922

Recruitment Status:

Recruiting

Sponsor:

Molecular Templates, Inc.

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There are 30 Locations for this study

See Locations Near You

Mayo Clinic (Arizona)
Phoenix Arizona, 85054, United States
St. Joseph Heritage Healthcare
Fullerton California, 92835, United States More Info
Linda Gozar
Contact
714-446-5177
[email protected]
Cancer and Blood Specialty Clinic
Los Alamitos California, 90720, United States More Info
Mimi Washington
Contact
562-735-0602
[email protected]
Cedars-Sinai Medical Center
Santa Monica California, 90048, United States More Info
Jasmine Garcia
Contact
310-967-4338
[email protected]
UCLA Hematology & Oncology
Santa Monica California, 90404, United States More Info
Lisa Yonemoto
Contact
310-794-6500
[email protected]
Sarah Cannon Research Institute
Denver Colorado, 80218, United States More Info
Joshua Gordon
Contact
720-754-2610
[email protected]
Sarah Kirk
Contact
720-754-2610
[email protected]
Sylvester Comprehensive Cancer Center (University of Miami)
Coral Gables Florida, 33146, United States More Info
Frances Valdes
Contact
305-243-5302
[email protected]
Yanel Diaz Caro
Contact
305-243-8227
[email protected]
South Broward Hospital District d/b/a Memorial Healthcare System
Hollywood Florida, 33021, United States More Info
Lisandra Perez
Contact
954-265-2619
[email protected]
Mayo Clinic (Florida)
Jacksonville Florida, 32224, United States
Orlando Health
Orlando Florida, 32806, United States More Info
Karin Donaldson
Contact
[email protected]
Kiera Grofsik
Contact
321-841-6626
[email protected]
South Broward Hospital District d/b/a Memorial Healthcare System
Pembroke Pines Florida, 33024, United States More Info
Florencia Tocacushe
Contact
954-844-9178
[email protected]
Josephine Caampued
Contact
954-265-1844
[email protected]
BRCR Medical Center
Plantation Florida, 33322, United States More Info
Vaneska Chacin
Contact
561-447-0614
[email protected]
Northwestern University
Chicago Illinois, 60611, United States More Info
William Gradishar, M.D.
Contact
312-695-0990
[email protected]
University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Jose Torio
Contact
773-702-1341
[email protected]
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Claudia Buenrostro Orduna
Contact
734-647-8902
[email protected]
Mayo Clinic (Minnesota)
Rochester Minnesota, 55905, United States More Info
Contact
855-776-0015
Washington University
Saint Louis Missouri, 63130, United States More Info
Katlyn Kraft, CCRP
Contact
314-747-5440
[email protected]
Sara Mitchum
Contact
314-273-8602
[email protected]
Novant Health Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Kunal Shah
Contact
980-302-6297
[email protected]
Novant Health Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States More Info
Andrea Marrs
Contact
336-718-8335
[email protected]
Nicole Goolsby
Contact
336-718-8521
[email protected]
Prisma Health
Greenville South Carolina, 29605, United States More Info
Lisa Johnson
Contact
864-455-6962
[email protected]
Fiona Davidson
Contact
(864) 455-6962
[email protected]
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Dee McComb
Contact
844-482-4812
[email protected]
Mary Crowley Cancer Research
Dallas Texas, 75251, United States More Info
Referral Office
Contact
972-566-3000
[email protected]
The University of Texas Health Science Center
San Antonio Texas, 78229, United States More Info
Maggie Tomasini
Contact
210-450-5962
[email protected]
Jennifer Moseley
Contact
210-450-1799
[email protected]
St. Vincent's Hospital Melbourne
Fitzroy Melbourne, VIC, 3065, Australia More Info
Nadia Ranieri
Contact
+61 3 9231 3167
[email protected]
Southern Highlands Cancer Centre
Bowral New South Wales, 2576, Australia More Info
Jeralyn Jacquet
Contact
+61 2 4862 9468
Macquarie University Hospital (Clinical Trials Unit)
Macquarie New South Wales, 2109, Australia More Info
Cancer Research South Australia
Adelaide South Australia, 5000, Australia More Info
Kelly Mead
Contact
+61 8 7070 2513
Sunshine Hospital - Western Health
Saint Albans Victoria, 3021, Australia More Info
Goulburn Valley Health
Shepparton Victoria, 3630, Australia More Info
Carole Mott
Contact
+61 3 5832 3777
[email protected]
New Zealand Clinical Research (Christchurch)
Christchurch , 8011, New Zealand More Info
Kathleen Bremner
Contact
+64 3 372 9477
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

178

Study ID:

NCT04029922

Recruitment Status:

Recruiting

Sponsor:


Molecular Templates, Inc.

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