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

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

NCT ID: NCT06385925

Condition: Malignant Neoplasm

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
solid tumor
KRAS G12D mutation
pancreatic cancer
colorectal cancer
non-small cell lung cancer
malignant neoplasm

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TSN1611
Description: TSN1611 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Arm group label: Phase 1: Dose-finding/evaluation of TSN1611 monotherapy
Arm group label: Phase 2: Dose expansion of TSN1611 monotherapy

Summary: 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.

Detailed description: Phase 1 Part: The phase 1 part will evaluate the prespecified dose levels of TSN1611. Dose escalation will continue until up to the highest planned dose or the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. Dose optimization could be performed as indicated by the emerging data. Phase 2 Part: Phase 2 part will evaluate the efficacy and safety of TSN1611 as monotherapy at the recommended dose in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.

Criteria for eligibility:
Criteria:
Subjects must meet all the following inclusion criteria 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. - Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; subjects must be refractory or intolerable to standard treatment, or have no standard treatment available, etc. - Patients with adequate cardiac, liver, renal function, etc. Exclusion Criteria Subjects 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 full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Siqing Fu, MD, PhD

Facility:
Name: NEXT Oncology

Address:
City: San Antonio
Zip: 78229
Country: United States

Status: Recruiting

Contact:
Last name: David Sommerhalder, MD, PhD

Facility:
Name: NEXT Virginia

Address:
City: Fairfax
Zip: 22031
Country: United States

Status: Recruiting

Contact:
Last name: Alexander Spira, MD, PhD

Start date: April 29, 2024

Completion date: April 30, 2027

Lead sponsor:
Agency: Tyligand Bioscience (Shanghai) Limited
Agency class: Industry

Source: Tyligand Bioscience (Shanghai) Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06385925