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New treatment option for Has a Pathologically Documented Unresectable Locally Advanced or...
Official title TSN222 in Subjects With Advanced Solid Tumors or Lymphomas
ClinicalTrials.gov ID: NCT05842785
What this study is testing
What is Phase I dose escalation?
Phase I dose escalation is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for has a pathologically documented unresectable locally advanced or metastatic solid tumor or lymphoma.
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
- The study is a first-in-human [FIH], open-label phase 1/2 study of TSN222 in subjects with advanced solid tumors or lymphomas. This study is comprised of a Phase 1 dose escalation and Phase 2 dose expansion component.
- 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
- people must meet all the following to be eligible for participation in this study:
- The subject fully understands the requirements of the study and voluntarily signs the ICF.
- At least 18 years of age at the time of informed consent.
- Life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
You likely can't join if
- people will be excluded if they meet any of the following criteria:
- Untreated or symptomatic central nervous system (CNS) metastases. Note: people with asymptomatic treated CNS metastases are eligible provided they...
- Prior history of active malignant disease other than that being treated in this study. Exceptions: malignancies that were treated curatively and have...
- Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia and grade 2 peripheral neuropathy.
- Prior systemic anti-cancer treatment (chemotherapy, biologic therapy, or targeted therapy or herbal medicine) within 3 weeks or 5 half-lives...
- Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy to a non-target lesion within 2 weeks prior to the...
See the full eligibility criteria
Who can join
- people must meet all the following to be eligible for participation in this study:
- The subject fully understands the requirements of the study and voluntarily signs the ICF.
- At least 18 years of age at the time of informed consent.
- Life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Willing to provide tumor tissues and accept tumor biopsies during study.
- At least one measurable tumor lesion per RECIST v1.1 or Lugano 2014 response criteria (only applicable for phase 2); note: the measurable lesions should be non-injected and non-biopsied during study.
- people must meet the following criteria for each of the respective parts of the study Phase 1 part: Has a pathologically documented unresectable locally advanced or metastatic solid tumor or lymphoma that is refractory...
What rules you out
- people will be excluded if they meet any of the following criteria:
- Untreated or symptomatic central nervous system (CNS) metastases. Note: people with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4...
- Prior history of active malignant disease other than that being treated in this study. Exceptions: malignancies that were treated curatively and have not recurred within the past 5 years (i.e., completely resected basal...
- Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia and grade 2 peripheral neuropathy.
- Prior systemic anti-cancer treatment (chemotherapy, biologic therapy, or targeted therapy or herbal medicine) within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug; or prior...
- Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy to a non-target lesion within 2 weeks prior to the first dose of study drug.
- Has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to the first dose of study drug.
- Major surgery within 4 weeks prior to first dose of study drug.
- Severe infection within 4 weeks prior to the first dose of study drug, active infection requiring oral or intravenous antibiotics within 2 weeks prior to the first dose of study drug.
- Active viral hepatitis.
- History of human immunodeficiency virus (HIV) infection.
- Known interstitial lung disease history, or current active pneumonitis, radiation pneumonitis requiring hormonal therapy, or uncontrolled lung disease.
- Symptomatic uncontrolled effusion in body cavities (e.g., pleural effusion, ascites and pericardial effusion).
- History of significant bleeding event (\> 30ml) within 3 months before the first dosing or hemoptysis (\> 2.5 mL of bright red blood or at least 0.5 teaspoon per episode) within 4 weeks before the first dosing；
- Severe cardiovascular disease within 6 months of the first dose including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina, New York Heart Association (NYHA) class III or IV...
- Uncontrolled hypertension (systolic pressure \>150mmHg or diastolic pressure \> 90mmHg).
- Has the average corrected QT interval by Fridericia's formula (QTcF) prolongation to \> 480 millisecond (ms) based on 12-lead electrocardiograph (ECG) in triplicate, or with a history of additional risk factors for...
- Severe gastrointestinal disease, including but not limited to:
- Peptic ulcer disease in the past 3 months prior to the first dosing.
- Clinically significant gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months prior to the first dosing without evidence of resolution documented by endoscopy or colonoscopy.
- Active colitis requiring ongoing treatment within 4 weeks prior to the first dosing, including infectious colitis, radiation colitis and ischemic colitis.
- History of ulcerative colitis or Crohn's disease.
- Active autoimmune diseases or history of autoimmune diseases that may relapse, or high-risk conditions (e.g., prior allogeneic hematopoietic stem cell transplantation or organ transplantation that requires...
- Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of investigational product...
- Topical, ocular, intra articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.
- Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact...
- Receipt of any live vaccines within 4 weeks prior to first dose of study drug.
- Females who are pregnant or nursing.
- Has a history or current evidence of any severe condition, concurrent therapy, or laboratory abnormality that might confound the interpretation of the study results, interfere with the subject's participation for the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 Shanghai, Shanghai Municipality, China. 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.