Study of MT-5111 in HER2-positive Solid Tumors

Stopped early · Phase 1

Conditions studied: HER2-positive Solid Cancers

In brief

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

Key facts

Study ID

NCT04029922

Run by

Molecular Templates, Inc.

People needed

50

Starts

2019-11-12

Expected to finish

2023-04-27

Last updated by the study team

2023-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mayo Clinic (Arizona) — Phoenix, Arizona, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• Cedars-Sinai Medical Center — Santa Monica, California, United States
• UCLA Hematology & Oncology — Santa Monica, California, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Sylvester Comprehensive Cancer Center (University of Miami) — Coral Gables, Florida, United States
• South Broward Hospital District d/b/a Memorial Healthcare System — Hollywood, Florida, United States
• Mayo Clinic (Florida) — Jacksonville, Florida, United States
• Orlando Health — Orlando, Florida, United States
• South Broward Hospital District d/b/a Memorial Healthcare System — Pembroke Pines, Florida, United States
• BRCR Medical Center — Plantation, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic (Minnesota) — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Novant Health Cancer Institute — Charlotte, North Carolina, United States
• Novant Health Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Prisma Health — Greenville, South Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• The University of Texas Health Science Center — San Antonio, Texas, United States
• St. Vincent's Hospital Melbourne — Fitzroy, Melbourne, VIC, Australia
• Southern Highlands Cancer Centre — Bowral, New South Wales, Australia

Full record on ClinicalTrials.gov

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