Study of TTX-MC138 in Subjects With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Registration Number
- NCT06260774
- Lead Sponsor
- TransCode Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Have histologically or cytologically confirmed diagnosis of relapsed/refractory<br> metastatic or locally advanced solid tumor where no standard therapy exists,<br> standard therapy has failed and have no available therapies with known clinical<br> benefit.<br><br> 2. Must have measurable or evaluable disease per RECIST version 1.1.<br><br> 3. =18 years at the time of informed consent.<br><br> 4. Life expectancy of =3 months<br><br> 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or<br> equal to 2.<br><br> 6. Have adequate organ function defined as:<br><br> 1. Platelet count =75×109/L with no platelet transfusions in the past 7 days<br><br> 2. Absolute neutrophil count =1.0×109/L<br><br> 3. Hemoglobin =8 g/dL (red blood cell transfusion may be used to reach 8 g/dL but<br> must have been administered at least 1 week prior to the administration of the<br> study drug)<br><br> 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5× the<br> upper limit of normal (ULN) if no hepatic metastases are present; <5× ULN if<br> hepatic metastases are present<br><br> 5. Total bilirubin <1.5× ULN; <3 X ULN in the presence of Gilbert's disease<br><br> 6. Estimated (Cockcroft-Gault formula) or measured creatinine clearance =60 mL/min<br><br> 7. International normalized ratio (INR) =1.5× ULN unless participant is receiving<br> anticoagulant therapy as long as the prothrombin time (PT) or activated partial<br> thromboplastin time (aPTT) is within therapeutic range of intended use of<br> anticoagulants<br><br> 7. If female of childbearing potential, either abstain from sexual intercourse or<br> employ highly effective contraception measures during the study and for =30 days<br> after the administration of the study drug. Highly effective measures include 2<br> forms of contraception. Postmenopausal or surgically sterile women (ie,<br> hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) are eligible.<br> Postmenopausal status is defined as either: amenorrheic for =12 months following<br> cessation of exogenous hormonal treatments and without an alternative medical cause;<br> luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal<br> range for women <50 years of age; radiation-induced ovarian ablation with last<br> menses =1 year ago; or chemotherapy-induced menopause with a =1-year interval since<br> last menses. Female subjects must refrain from donating or banking eggs (ova,<br> oocytes) and retrieving eggs for use during study treatment and for 30 days after<br> the administration of the study drug.<br><br> 8. For male subjects not surgically sterile, must either abstain from sexual<br> intercourse or employ highly effective contraception (condoms or other barrier forms<br> of contraception) during the study and for at least 30 days after the administration<br> of the study drug. Male subjects should also avoid semen donation or providing semen<br> for in vitro fertilization during the above-mentioned duration.<br><br> 9. Able to understand and willing to provide informed consent and able to comply with<br> the study procedures, including biopsy, and restrictions.<br><br>Exclusion Criteria:<br><br> 1. Unwilling or unable to comply with scheduled visits, study drug administration plan,<br> laboratory tests, or other study procedures and study restrictions.<br><br> 2. Have received anticancer therapy (including both systemic therapy and radiotherapy,<br> but not including immunotherapy or other antibody therapies) within 14 days or 5<br> half-lives (whichever is shorter) of study drug administration or;<br><br> a. received antibody therapy within 30 days before the start of study drug<br> administration.<br><br> 3. Have a history of a second primary malignancy that has been diagnosed or required<br> active therapy within the past year.<br><br> a. Note: The following prior malignancies are not exclusionary: completely resected<br> basal cell and squamous cell skin cancer, curatively treated localized prostate or<br> breast cancer, curatively treated localized thyroid cancer, and completely resected<br> carcinoma in situ of any site.<br><br> 4. Have central nervous system (CNS) metastases or primary CNS tumor that is associated<br> with progressive neurologic symptoms or requires ongoing corticosteroids to control<br> the CNS disease. Subjects must have a stable neurologic status without steroid<br> support for =2 weeks before the start of study drug administration. Subjects with<br> stable or asymptomatic CNS metastases or primary CNS are eligible.<br><br> 5. Require treatment with traditional/herbal medicines or their preparations indicated<br> for tumors or with adjuvant anti-tumor effects that cannot be discontinued during<br> the study.<br><br> 6. Have clinically significant, uncontrolled cardiovascular disease including<br> congestive heart failure Class III or Class IV according to the New York Heart<br> Association classification; myocardial infarction or unstable angina within the<br> previous 6 months; uncontrolled hypertension (Grade =3); or clinically significant,<br> uncontrolled arrhythmia, including bradyarrhythmia that may cause QT prolongation<br> (eg, Type II second-degree heart block or third-degree heart block).<br><br> 7. Have QT interval corrected using Fridericia's formula >480 msec. Unless the subject<br> has a history of prolonged QT syndrome or torsade de pointes or a familial history<br> of prolonged QT syndrome.<br><br> 8. Have a history of acute ischemic stroke, diagnosed by imaging (CT or MRI) or<br> clinical diagnosis within 6 months prior to screening.<br><br> 9. Have any severe or uncontrolled systemic disease or condition per clinical<br> judgement, including: (i) uncontrolled hypertension or diabetes; (ii) serious<br> cardiac, pulmonary, or renal conditions; (iii) active bleeding diatheses; (iv) any<br> active type of bacterial, viral, fungal, or other infection that would pose a<br> significant risk to the subject in the opinion of the Investigator; (v)<br> cerebrovascular accident within the last 6 months before administration of study<br> drug.<br><br> 10. Have received a major surgical procedure within 28 days before the start of study<br> drug administration (procedures such as central venous catheter placement and tumor<br> needle biopsy are not considered major surgical procedures). The study center should<br> discuss other minor surgeries with the sponsor.<br><br> 11. Clinical diagnosis of hemochromatosis or secondary iron overload,<br><br> 12. Have known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C<br> virus infection that is not well-controlled and meets any of the following exclusion<br> criteria:<br><br> 1. Documented detectable HIV RNA within 4 weeks of study drug administration,<br><br> 2. Acquired immunodeficiency syndrome defining opportunistic infections within the<br> past 12 months prior to study enrollment, and<br><br> 3. Is not on antiretroviral therapy for at least 4 weeks prior to study<br> enrollment.<br><br> 13. Have clinical signs or symptoms consistent with COVID-19 infection or confirmed<br> infection by appropriate laboratory test (done at the discretion of Investigator or<br> per local regulation) within the last 2 weeks before the administration of the study<br> drug. In case of confirmed COVID-19 infection before screening, documen
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose Escalation - Adverse Events;Dose Escalation - Overall Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method