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RecruitingLast updated: 22 April 2024

MT-5111: This phase I/II is investigating the appropriate dose level and effectiveness of a new cancer drug (MT-5111) in people with HER2-positive solid cancersA Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors

Clinical summary

Summary

This study will be conducted in two parts. Part 1 (dose escalation) aims to determine the recommended phase 2 dose (RP2D) to be used in Part 2. Part 1 will consist of participants with any type of HER2-positive solid cancer. Part 2 (dose expansion) aims to confirm how safe and tolerable the RP2D of MT-5111 is. Part 2 will consist of people with any type of HER2-positive solid cancers, including breast cancer, gastric or gastroesophageal adenocarcinomas. MT-5111 will be administered via intravenous infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).

Conditions

This trial is treating patients with HER2-positive solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

MT-5111

More information

Trial Identifiers

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Trial sponsor

Molecular Templates, Inc.

Scientific Title

A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors

Eligibility

Inclusion

  1. 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).
  2. HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a metastatic lesion in cases of metastatic cancers).
  3. Relapsed or refractory to or intolerant of existing therapy(ies)
  4. 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)
  5. ECOG performance score of ≤ 1
  6. 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
  7. Kidney function:

    • Creatinine clearance (CLcr) ≥ 50 mL/min either measured or estimated using the Cockcroft-Gault formula
  8. 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
  9. 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

  1. History or current evidence of another tumor that is histologically distinct from the tumor under study
  2. Current evidence of new or growing CNS metastases during screening

    • Subjects with known CNS metastases will be eligible if they meet protocol specified criteria
  3. 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
  4. History or evidence of significant cardiovascular disease
  5. 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
  6. Current evidence of ≥ grade 2 underlying pulmonary disease
  7. Certain exclusionary prior treatments

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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