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Tests treatment safety and results for Gastroesophageal Cancer (GC)
Official title A Phase 1 Study of the Safety and Tolerability of CTX-10726
ClinicalTrials.gov ID: NCT07419841
What this study is testing
What is CTX-10726?
CTX-10726 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastroesophageal cancer (gc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older.
- Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is...
- Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to...
- Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PDL1) treatment.
- Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI).
You likely can't join if
- Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to...
- Prior organ transplantation.
- History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.
- History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or...
- Symptomatic or uncontrolled central nervous system (CNS) and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or...
- A pleural, abdominal (eg, ascites) or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc)...
See the full eligibility criteria
Who can join
- Age 18 years or older.
- Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy...
- Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means.
- Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PDL1) treatment.
- Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI).
- Patients who received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose or received major surgical treatment within 3 weeks before the first dose are not eligible. 2b...
- Patients who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment.
- Patient must have received one of the following regimens: ipilimumab+nivolumab, tremelimumab+durvalumab, atezolizumab+bevacizumab or lenvatinib+pembrolizumab.
- Hepatic function: Child -Pugh A and Child-Pugh B7.
- Receipt of local area treatment of the liver more than 4 weeks prior to the first dose is allowed. 2c. Gastroesophageal Cancer (GC)
- Patients who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment.
- Patients must have received prior treatment with platinum-based chemotherapy. 2d: Endometrial Cancer (EC)
- Patients must have received at least 1 cycle of platinum-based chemotherapy.
- Patients with newly diagnosed advanced endometrial cancer that have persistent lesion(s) after standard treatment with surgery and chemotherapy ± radiotherapy.
- Patients with MSI- high or deficient DNA mismatch repair (dMMR) tumors who have progressed after a minimum of 2 doses of a PD-1/PDL1 treatment. 3\. Patients must have measurable disease per RECIST 1.1. Tumor sites that...
- Bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion).
- Hepatic function defined as serum total bilirubin ≤ 1.5 × ULN (\<3 x ULN in patients with Gilbert's syndrome), AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases).
- Renal function defined as creatinine clearance ≥ 30 mL/min by Cockcroft Gault equation.
- Cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%. 6\. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or...
What rules you out
- Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to discontinuation of treatment. A prior irAE may be considered not...
- Prior organ transplantation.
- History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.
- History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.
- Symptomatic or uncontrolled central nervous system (CNS) and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided...
- A pleural, abdominal (eg, ascites) or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc) within 14 days of dosing with CTX-10726.
- Imaging at screening that shows the tumor surrounds important blood vessels or had obvious necrosis and voids, and the investigators deems that it might cause bleeding risk.
- The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.
- A history of significant bleeding tendency or severe coagulopathy.
- Current therapeutic dose of anticoagulant or thrombolytic medication within 14 days of the first dose. Note: prophylactic use of low molecular heparin (ie, enoxaparin 40 mg/day) is allowed.
- Current or recent use of aspirin (\> 325 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days of first dose.
- Known uncontrolled diabetes mellitus despite optimized anti-diabetes medications.
- The presence of poorly controlled hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP]) \>140/90 mmHg (eg, patient with SBP/DBP \> 140/90 mmHg despite ≥3 anti-hypertensive medications within 7 days...
- Pregnant or lactating WOCBP.
- Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately...
- Hepatitis B people who meet the following criteria are also eligible for inclusion: HBV viral load must be \< 1000 copies /ml (200 IU/ml) prior to initial dosing, and people should receive anti-HBV therapy to avoid...
- HIV-infected people who meet the following criteria are eligible for inclusion: HIV-RNA levels below the lower limit of detection.
- Active HCV-infected people (HCV antibody positive and HCV-RNA levels above the lower limit of detection).
- Patients that received attenuated vaccination within 4 weeks prior to screening or planning to receive attenuated vaccination during the study period.
- Current or recent systemic therapy with immunosuppressive agents within 7 days before the start of CTX-10726 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement (≤ 10...
- Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \> 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible...
- Active or prior documented idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except localized interstitial pneumonia due to radiotherapy...
- Other medical conditions in the opinion of the Investigator and/or Sponsor Medical Monitor may interfere with the conduct and/or interpretation of the current study, including:
- Congestive heart failure (\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant...
- QTc interval (using Fridericia correction calculation) \> 480 msec.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- Lake Success, New York, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Omaha, Nebraska, United States; Lake Success, New York, United States; Pittsburgh, Pennsylvania, United States; Greenville, South Carolina, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.