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Monoclonal Antibodies

Phase 1: Dose-finding/evaluation of TSN1611 monotherapy 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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).See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicities (DLTs) in phase 1 part

Objective response rate (ORR) in phase 2 part

Secondary outcome measures

Adverse events

Area under the plasma concentration-time curve (AUC)

Disease control rate (DCR)

+6 more

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.

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current clinical trial open for new participant enrollment?

"Indeed, as outlined on clinicaltrials.gov, this investigation is currently in search of eligible individuals. The trial was first made available on April 30th, 2024 and the most recent update was on April 23rd, 2024. They aim to recruit a total of 150 patients distributed among three distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

2024. "A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06385925.

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