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New treatment option for Malignant Neoplasm
Official title A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
ClinicalTrials.gov ID: NCT06385925
What this study is testing
What is TSN1611?
TSN1611 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant neoplasm.
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, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part.
- 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 to 75
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.≤ 75 years of age for Cohort B and C.
- 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:
- Leptomeningeal disease or Active central nervous system (CNS) metastases.
- Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter will be used as the criteria) prior to the first dose of...
- Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy within 1 week prior to the first dose of study drug.
- Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia.
- Has participated in a study of investigational agent and received the investigational agent within 21 days or 5 half-lives, if known (whichever is...
See the full eligibility criteria
- 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.≤ 75 years of age for Cohort B and C.
- Life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Phase 1 part (1a/1b) of Monotherapy: people with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; people must be refractory or intolerable to standard...
- Patients with adequate cardiac, liver, renal function, etc.
- people will be excluded if they meet any of the following criteria:
- Leptomeningeal disease or Active central nervous system (CNS) metastases.
- Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter will be used as the criteria) prior to the first dose of study drug.
- Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy within 1 week prior to the first dose of study drug.
- Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia.
- Has participated in a study of investigational agent and received the investigational agent within 21 days or 5 half-lives, if known (whichever is shorter) prior to the first dose of study drug.
- History of interstitial lung disease (ILD), drug induced IDL, or current active pneumonitis, radiation pneumonitis requiring therapeutic intervention, or uncontrolled other lung disease.
- Any of the following in the past 6 months: myocardial infarction, unstable angina, symptomatic congestive heart failure, stroke or transient ischemic attack, pulmonary embolism.
- Prior treatment with KRAS G12D targeted therapy.
- 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
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanchang, Jiang, China
- Linyi, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Taizhou, Zhejiang, China
- Beijing, China
- Shanghai, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China and 10 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.