A Phase 1/2 interventional study of TSN1611 and TSN1611 in Malignant Neoplasm, sponsored by Tyligand Pharmaceuticals (Suzhou) Limited. Recruiting at 19 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Tyligand Pharmaceuticals (Suzhou) Limited · Phase 1/2, Interventional, and Treatment
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. This study will evaluate the efficacy of TSN1611 at RP2D(s) through ORR using RECIST version 1.1, and determine and confirm the MTD/RP2D for TSN1611 in combination with cetuximab, in combination with cetuximab and mFOLFOX6, in combination with gemcitabine and albumin-bound paclitaxel in subjects with selected solid tumors.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 440 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
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.
Exclusion Criteria
Subjects will be excluded if they meet any of the following criteria:
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.
Drug: TSN1611
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.
Drug: TSN1611
Cohort A: TSN1611 combined with cetuximab treating subjects with advanced solid tumors harboring KRAS G12D mutation:
Drug: TSN1611
Cohort B: TSN1611 combined with GnP regimen (i.e., gemcitabine and nab-paclitaxel) treating subjects with advanced PDAC with KRAS G12D mutation who received no prior systemic treatment in the advanced setting.
Drug: TSN1611
Cohort C: TSN1611 combined with cetuximab and mFOLFOX6 regimen (i.e., fluorouracil, leucovorin, oxaliplatin) treating subjects with advanced CRC with KRAS G12D mutation who received no prior systemic treatment in the advanced setting.
Drug: TSN1611
TSN1611 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
TSN1611 BID, Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
TSN1611 BID, Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.
Also known as: Paclitaxel (albumin-bound)
TSN1611 BID everyday and Patients will be administered with mFOLFOX6 on Days 1 and 2, every 2 weeks.
Also known as: Oxaliplatin injection, fluorouracil, leucovorin
Dose limiting toxicities (DLTs) in phase 1 part
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose(s) (RP2D\[s\]) of TSN1611 as monotherapy in subjects with KRAS G12D mutant advanced solid tumors.
Time frame: 21 days
Objective response rate (ORR) in phase 2 part
To evaluate the anti-tumor activity of TSN1611 using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 3 years
Adverse events
To assess the safety profile and tolerability of TSN1611 as monotherapy in subjects with KRAS G12D mutant advanced solid tumors.
Time frame: Up to 3 years
Area under the plasma concentration-time curve (AUC)
To characterize the pharmacokinetic (PK) profile of TSN1611.
Time frame: 9 weeks
Maximum blood concentrations (Cmax)
To characterize the PK profile of TSN1611.
Time frame: 9 weeks
Time to maximum blood concentration (Tmax)
To characterize the PK profile of TSN1611.
Time frame: 9 weeks
Duration of response (DOR)
To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Time frame: Up to 3 years
Time to response (TTR)
To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Time frame: Up to 3 years
Disease control rate (DCR)
To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Time frame: Up to 3 years
Progression free survival (PFS)
To evaluate the anti-tumor activity of TSN1611 using RECIST version 1.1.
Time frame: Up to 3 years
Overall survival
Time frame: Up to 3 years
Plan to share: No
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