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Monoclonal Antibodies

TSN1611 for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Tyligand Bioscience (Shanghai) Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Must not have
Leptomeningeal disease or active central nervous system (CNS) metastases
Unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing a new drug called TSN1611 in patients with advanced solid tumors that have a specific genetic mutation. The trial will have two parts: one to determine the best dose of the

Who is the study for?
This trial is for people with advanced solid tumors that have a specific genetic change called KRAS G12D mutation. Details on who can join or reasons for exclusion are not provided.
What is being tested?
TSN1611, a new potential cancer treatment, is being tested in patients with certain advanced solid tumors. The study has two parts: finding the right dose (phase 1) and then seeing how well it works at that dose (phase 2).
What are the potential side effects?
Specific side effects of TSN1611 are not listed, but common ones for cancer treatments include nausea, fatigue, risk of infection, and reactions at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is advanced or has spread, tests show a KRAS G12D mutation, and standard treatments haven't worked or aren't suitable for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to the brain or spinal cord.
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I don't have lasting side effects from cancer treatment, except for hair loss.
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I haven't taken any experimental drugs within the last 21 days or 5 half-lives before starting the study drug.
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I have been treated with a KRAS G12D inhibitor before.
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I have a history of lung disease or current lung issues needing treatment.
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I haven't had a heart attack, stroke, or serious heart issues in the last 6 months.
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I have not had intensive radiation in the last 4 weeks or palliative radiation in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicities (DLTs) in phase 1 part
Objective response rate (ORR) in phase 2 part
Secondary study objectives
Adverse events
Area under the plasma concentration-time curve (AUC)
Disease control rate (DCR)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2: Dose expansion of TSN1611 monotherapyExperimental Treatment1 Intervention
Phase 2 part will evaluate the efficacy and safety of TSN1611 as monotherapy at the recommended dose level in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.
Group II: Phase 1: Dose-finding/evaluation of TSN1611 monotherapyExperimental Treatment1 Intervention
The phase 1 part will evaluate the prespecified sequential dose levels of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors to determine the recommended dose of TSN1611 for further investigation.

Find a Location

Who is running the clinical trial?

Tyligand Bioscience (Shanghai) LimitedLead Sponsor
3 Previous Clinical Trials
350 Total Patients Enrolled
Cindy LiStudy DirectorTyligand Bioscience (Shanghai) Limited
~100 spots leftby Oct 2026
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