Actively Recruiting
TSN222 in Subjects With Advanced Solid Tumors or Lymphomas
Led by Tyligand Bioscience (Shanghai) Limited · Updated on 2024-07-29
162
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TSN222 in Subjects With Advanced Solid Tumors or Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the study requirements and voluntarily signs informed consent
- At least 18 years old at the time of consent
- Has a life expectancy of 3 months or more
- Has an ECOG performance status of 0 or 1
- Willing to provide tumor tissue samples and accept biopsies during the study
- Has at least one measurable tumor lesion not injected or biopsied during the study (for phase 2 only)
- For phase 1: Has a pathologically confirmed unresectable locally advanced or metastatic solid tumor or lymphoma refractory or intolerable to standard treatment or with no available standard treatment
- For phase 2 cohort 1: Has unresectable locally advanced or metastatic head and neck squamous cell carcinoma refractory or intolerable to at least one systemic treatment
- For phase 2 cohort 2: Has unresectable locally advanced or metastatic melanoma refractory or intolerable to at least two systemic treatments if BRAF mutant, or at least one systemic treatment if BRAF non-mutant
- For phase 2 cohort 3: Has unresectable locally advanced or metastatic other solid tumors or lymphomas refractory or intolerable to at least one systemic treatment or no standard treatment available
- Has adequate bone marrow function
- Has adequate renal function with estimated creatinine clearance ≥ 50 mL/min
- Has adequate liver function including blood albumin ≥ 30 g/L
- Has adequate coagulation function
- Women of childbearing potential and men agree to use contraception during treatment and for at least 6 months after the last dose
You will not qualify if you...
- Has untreated or symptomatic central nervous system metastases (stable treated CNS metastases allowed if no steroids and stable for at least 4 weeks)
- Has active malignant disease other than the one being treated, except certain treated cancers with no recurrence in 5 years (phase 2 only)
- Has unresolved grade 2 or higher toxicity from prior anticancer therapy except alopecia and grade 2 peripheral neuropathy
- Received systemic anti-cancer treatment within 3 weeks or immunotherapy within 4 weeks prior to first dose
- Received radical radiation within 4 weeks or palliative radiation within 2 weeks prior to first dose
- Participated in another investigational study within 4 weeks prior to first dose
- Underwent major surgery within 4 weeks prior to first dose
- Had severe infection within 4 weeks or active infection requiring antibiotics within 2 weeks prior to first dose
- Has active viral hepatitis
- Has history of HIV infection
- Has known interstitial lung disease, current active pneumonitis, or uncontrolled lung disease
- Has symptomatic uncontrolled effusions in body cavities
- Had significant bleeding event within 3 months or hemoptysis within 4 weeks before first dose
- Has severe cardiovascular disease within 6 months prior to first dose
- Has uncontrolled high blood pressure
- Has prolonged QT interval or risk factors for torsade de pointes
- Has severe gastrointestinal disease including recent peptic ulcer, significant bleeding, active colitis, or history of ulcerative colitis or Crohn's disease
- Has active or relapsing autoimmune diseases or high-risk conditions requiring immunosuppression, except controlled type 1 diabetes or autoimmune hypothyroidism
- Requires systemic corticosteroids or immunosuppressive medication within 14 days before first dose, with some exceptions
- Received any live vaccine within 4 weeks prior to first dose
- Is pregnant or nursing
- Has any severe condition or therapy that may interfere with study participation or results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan Cancer Hospital
Shanghai, Shanghai Municipality, China, 200063
Actively Recruiting
Research Team
T
Tyligand Clinical Trial Info
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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