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New treatment option for Advanced Solid Tumor
Official title XTX301 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05684965
What this study is testing
What is XTX301?
XTX301 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
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 first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
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
- Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has...
- ECOG performance status of 0-2 for Phase 1
- ECOG performance status of 0 or 1 for Phase 2
- Adequate organ function
- Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after...
You likely can't join if
- Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)
- Known liver metastasis based on imaging
- Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture
- Active primary central nervous system (CNS) malignancy, CNS metastases, and/or carcinomatous meningitis
- Active autoimmune disease
- History of Grade ≥ 3 immune-related adverse events associated with prior immunotherapy unless these were adequately resolved with therapy within 14...
See the full eligibility criteria
- Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit...
- ECOG performance status of 0-2 for Phase 1
- ECOG performance status of 0 or 1 for Phase 2
- Adequate organ function
- Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment
- Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery before receiving study drug
- Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)
- Known liver metastasis based on imaging
- Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture
- Active primary central nervous system (CNS) malignancy, CNS metastases, and/or carcinomatous meningitis
- Active autoimmune disease
- History of Grade ≥ 3 immune-related adverse events associated with prior immunotherapy unless these were adequately resolved with therapy within 14 days
- A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of study drug
- Active hepatitis B or active hepatitis C infection
- Prior treatment with gene therapy, organ transplant, or hematopoietic stem-cell transplant
- Known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- New Haven, Connecticut, United States
- Saint Louis Park, Minnesota, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Canton, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Webster, Texas, United States
- Milwaukee, Wisconsin, United States
- Sheboygan, Wisconsin, 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 Sacramento, California, United States; New Haven, Connecticut, United States; Saint Louis Park, Minnesota, United States; St Louis, Missouri, United States; Hackensack, New Jersey, United States; Canton, Ohio, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.