- for people ages 18 years and up (full criteria)
- at UCLA
- study startedestimated completion
This will be a Phase 1, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) in subjects with HER2-positive solid tumors.
A Phase 1 Open-label, Multicenter Dose Escalation Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors
This study will be conducted in two sequential parts:
- Part 1 (Dose Escalation): The purpose of Part 1 is to determine the Phase 2 dose (RP2D) to be used in Part 2. Part 1 will include any type of HER2-positive solid cancer.
- Part 2 (Dose Expansion): The purpose of Part 2 is to confirm the safety and tolerability of the RP2D of MT-5111. Part 2 will include any type of HER2-positive solid cancer, including breast cancer, gastric or gastroesophageal adenocarcinomas (GEA).
Up to 140 eligible subjects will be identified and treated through competitive enrollment at multiple study centers.
In Parts 1 and 2 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 doses of MT-5111 over a 21-day treatment cycle)
- 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.
HER2-positive Solid Cancers MT-5111 (experimental study drug)
You can join if…
Open to people ages 18 years and up
- Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:
- Part 1 (Dose-Escalation): All HER2-positive solid cancers are eligible
- Part 2 (Dose-Expansion): Any type of HER2-positive solid cancer, including breast cancer, 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
- ECOG performance score of ≤ 1
- Bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3
- Platelet count ≥ 75,000 mm³ and
- Hemoglobin ≥ 8.0 g/dL
- No red blood cell transfusion within 4 weeks of study treatment start is allowed
- Kidney function:
- (eGFR) ≥ 50 mL/min calculated by the Cockcroft-Gault formula
- Subjects with CLcr ≥ 50 mL/min will be eligible irrespective of the eGFR result
- Cardiac Function:
- Left ventricular ejection fraction (LVEF) ≥ 55% on the multigated acquisition (MUGA) scan (preferred) or echocardiogram (ECHO) assessment, 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, and
- AST ≤ 3 x ULN and ALT ≤ 3 x ULN
- < 5 x ULN (if hepatic metastases)
You CAN'T join 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 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
- UCLA Hematology & Oncology
accepting new patients
Santa Monica California 90404 United States
- The University of Texas Health Science Center
accepting new patients
San Antonio Texas 78229 United States
- accepting new patients
- Start Date
- Completion Date
- Molecular Templates, Inc.
- Phase 1
- Study Type
- Last Updated