A Phase I/II Multicenter, Open-Label, Dose-escalation and Expansion Study of TTX-MC138 in Subjects With Advanced Solid Tumors

Study Identifier:
TTX-MC138-002
CT.gov Identifier:
NCT06260774
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors

Phase 1a objective: Safety assessment (3 Dose Levels)

Phase 1b objective: Exploratory Clinical Pharmacology ( Dose Level)

To assesses safety & RP2D* and potential indication of clinical pharmacology (target inhibition)

To evaluate the safety and preliminary anti-tumor activity of TTX-MC138

To include patients with a variety of metastatic solid cancers.

To generate critical data to support evaluation of the safety of TTX-MC138 in patients with a variety of metastatic solid cancer. It may provide early evidence of TTX-MC138 clinical activity.

To evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18 - 80 Years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • 1. Have histologically or cytologically confirmed diagnosis of relapsed/refractory metastatic or locally advanced solid tumor where no standard therapy exists, standard therapy has failed and have no available therapies with known clinical benefit. 2. Must have measurable or evaluable disease per RECIST version 1.1. 3. ≥18 years at the time of informed consent. 4. Life expectancy of ≥3 months 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2. 6. Have adequate organ function defined as: 1. Platelet count ≥75×109/L with no platelet transfusions in the past 7 days 2. Absolute neutrophil count ≥1.0×109/L 3. Hemoglobin ≥8 g/dL (red blood cell transfusion may be used to reach 8 g/dL but must have been administered at least 1 week prior to the administration of the study drug) 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5× the upper limit of normal (ULN) if no hepatic metastases are present; <5× ULN if hepatic metastases are present 5. Total bilirubin <1.5× ULN; <3 X ULN in the presence of Gilbert's disease 6. Estimated (Cockcroft-Gault formula) or measured creatinine clearance ≥60 mL/min 7. International normalized ratio (INR) ≤1.5× ULN unless participant is receiving anticoagulant therapy as long as the prothrombin time (PT) or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants 7. If female of childbearing potential, either abstain from sexual intercourse or employ highly effective contraception measures during the study and for ≥30 days after the administration of the study drug. Highly effective measures include 2 forms of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) are eligible. Postmenopausal status is defined as either: amenorrheic for ≥12 months following cessation of exogenous hormonal treatments and without an alternative medical cause; luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for women <50 years of age; radiation-induced ovarian ablation with last menses ≥1 year ago; or chemotherapy-induced menopause with a ≥1-year interval since last menses. Female subjects must refrain from donating or banking eggs (ova, oocytes) and retrieving eggs for use during study treatment and for 30 days after the administration of the study drug. 8. For male subjects not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 30 days after the administration of the study drug. Male subjects should also avoid semen donation or providing semen for in vitro fertilization during the above-mentioned duration. 9. Able to understand and willing to provide informed consent and able to comply with the study procedures, including biopsy, and restrictions.
    Exclusion criteria
    • 1. Unwilling or unable to comply with scheduled visits, study drug administration plan,
    • laboratory tests, or other study procedures and study restrictions.
    • 2. Have received anticancer therapy (including both systemic therapy and radiotherapy,
    • but not including immunotherapy or other antibody therapies) within 14 days or 5
    • half-lives (whichever is shorter) of study drug administration or;
    • a. received antibody therapy within 30 days before the start of study drug
    • administration.
    • 3. Have a history of a second primary malignancy that has been diagnosed or required
    • active therapy within the past year.
    • a. Note: The following prior malignancies are not exclusionary: completely resected
    • basal cell and squamous cell skin cancer, curatively treated localized prostate or
    • breast cancer, curatively treated localized thyroid cancer, and completely resected
    • carcinoma in situ of any site.
    • 4. Have central nervous system (CNS) metastases or primary CNS tumor that is associated
    • with progressive neurologic symptoms or requires ongoing corticosteroids to control
    • the CNS disease. Subjects must have a stable neurologic status without steroid support
    • for ≥2 weeks before the start of study drug administration. Subjects with stable or
    • asymptomatic CNS metastases or primary CNS are eligible.
    • 5. Require treatment with traditional/herbal medicines or their preparations indicated
    • for tumors or with adjuvant anti-tumor effects that cannot be discontinued during the
    • study.
    • 6. Have clinically significant, uncontrolled cardiovascular disease including congestive
    • heart failure Class III or Class IV according to the New York Heart Association
    • classification; myocardial infarction or unstable angina within the previous 6 months;
    • uncontrolled hypertension (Grade ≥3); or clinically significant, uncontrolled
    • arrhythmia, including bradyarrhythmia that may cause QT prolongation (eg, Type II
    • second-degree heart block or third-degree heart block).
    • 7. Have QT interval corrected using Fridericia's formula >480 msec. Unless the subject
    • has a history of prolonged QT syndrome or torsade de pointes or a familial history of
    • prolonged QT syndrome.
    • 8. Have a history of acute ischemic stroke, diagnosed by imaging (CT or MRI) or clinical
    • diagnosis within 6 months prior to screening.
    • 9. Have any severe or uncontrolled systemic disease or condition per clinical judgement,
    • including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary,
    • or renal conditions; (iii) active bleeding diatheses; (iv) any active type of
    • bacterial, viral, fungal, or other infection that would pose a significant risk to the
    • subject in the opinion of the Investigator; (v) cerebrovascular accident within the
    • last 6 months before administration of study drug.
    • 10. Have received a major surgical procedure within 28 days before the start of study drug
    • administration (procedures such as central venous catheter placement and tumor needle
    • biopsy are not considered major surgical procedures). The study center should discuss
    • other minor surgeries with the sponsor.
    • 11. Clinical diagnosis of hemochromatosis or secondary iron overload,
    • 12. Have known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
    • infection that is not well-controlled and meets any of the following exclusion
    • criteria:
    • 1. Documented detectable HIV RNA within 4 weeks of study drug administration,
    • 2. Acquired immunodeficiency syndrome defining opportunistic infections within the
    • past 12 months prior to study enrollment, and
    • 3. Is not on antiretroviral therapy for at least 4 weeks prior to study enrollment.
    • 13. Have clinical signs or symptoms consistent with COVID-19 infection or confirmed
    • infection by appropriate laboratory test (done at the discretion of Investigator or
    • per local regulation) within the last 2 weeks before the administration of the study
    • drug. In case of confirmed COVID-19 infection before screening, documentation of
    • resolution of infection by appropriate laboratory test is required.
    • 14. Have received or are planning to receive a COVID-19 vaccination within 2 weeks before
    • or after the administration of the study drug. However, COVID-19 vaccinations received
    • >2 weeks before or after the administration of the study drug are permitted.
    • 15. Have received a live or live attenuated vaccines within 30 days before the
    • administration of the study drug.
    • 16. Have any unresolved clinically relevant toxicities from prior therapy, greater than
    • NCI CTCAE Grade 1 at the time of starting study treatment, except for alopecia.
    • 17. Have a history of hypersensitivity to active or inactive excipients of the study drug
    • or drugs with a similar chemical structure or class to the study drug, including
    • ferumoxytol (Feraheme).
    • 18. Have an active autoimmune disease (eg, rheumatoid arthritis, systemic lupus
    • erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing
    • spondylitis, thyroiditis) requiring continuing immune suppressive therapy, including
    • >10 mg prednisone per day or equivalent.
    • 19. Pregnant or breastfeeding at the time of screening or on Day 1 before TTX-MC138 as
    • documented by a serum beta human chorionic gonadotropin pregnancy test consistent with
    • pregnancy.
    • 20. Known current drug or alcohol abuse.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor