RecruitingRecruiting
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
NCT06385925 · Tyligand Pharmaceuticals (Suzhou) Limited
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation
About this study
Phase 1 Part of TSN1611 Monotherapy:
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 of TSN1611 Monotherapy:
hase 2 part of TSN1611 monotherapy will evaluate the efficacy and safety of TSN1611 as monotherapy at the RP2D until disease progression or unacceptable toxicity in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.
Phase 1b/2 Part of TSN1611 Combination Therapy:
This part will consist of the investigations of 3 combined therapies (Cohort A, B and C). In each cohort, there will be a Phase 1b Safety Lead-in Stage to determine the dose of TSN1611 for the combination therapy (this part will be conducted in selected sites), followed by the Phase 2 Expansion Stage to enroll more subjects to determine the efficacy in different cohorts.
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.≤ 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:
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, or the subject is ineligible or declines standard treatment.
Phase 2 part of TSN1611 Monotherapy:
Subjects with histologically or cytologically confirmed locally advanced or metastatic PDAC、CRC and NSCLC harboring KRAS G12D mutation; According to the requirements of different combined cohorts, the number of previous treatments is taken into account.
• 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.
Study design
Enrollment target: 440 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-29
Estimated completion: 2027-04-30
Last updated: 2026-04-24
Interventions
Drug: TSN1611Drug: TSN1611Drug: TSN1611Drug: TSN1611
Primary outcomes
- • Dose limiting toxicities (DLTs) in phase 1 part (21 days)
- • Objective response rate (ORR) in phase 2 part (Up to 3 years)
Sponsor
Tyligand Pharmaceuticals (Suzhou) Limited · industry
Contacts & investigators
ContactTyligand Clinical Trial Info · contact · clinical_trial@tyligand.com · +86 021-50720081
InvestigatorCindy Li · study_director, Tyligand Bioscience (Shanghai) Limited
All locations (19)
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
Anhui Provincial Cancer HospitalRecruiting
Hefei, Anhui, China
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
Hubei Cancer HospitalRecruiting
Wuhan, Hubei, China
Hunan Cancer HospitalRecruiting
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University - Donghu DistrictRecruiting
Nanchang, Jiang, China
Linyi Cancer HospitalRecruiting
Linyi, Shandong, China
Shanghai Tenth People's HospitalRecruiting
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital - Zhejiang University School of MedRecruiting
Hangzhou, Zhejiang, China
The First Affiliated Hospital - Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang ProvinceRecruiting
Taizhou, Zhejiang, China
Beijing Cancer Hospital, Beijing, ChinaRecruiting
Beijing, China
Shanghai Chest Hospital, Shanghai, ChinaRecruiting
Shanghai, China
Shanghai Zhongshan Hospital, Shanghai, ChinaRecruiting
Shanghai, China