A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (NCT06385925)
Phase 1/2 Study of TSN1611 in Subjects With Advanced Solid Tumors Harboring KRAS G12D Mutation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: MD Anderson Cancer Center — Houston, Texas
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- MD Anderson Cancer Center — Houston, Texas
- NEXT Oncology — San Antonio, Texas
- NEXT Virginia — Fairfax, Virginia
- Anhui Provincial Cancer Hospital — Hefei, Anhui
- Beijing Cancer Hospital — Beijing, Beijing Municipality
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong
- Hubei Cancer Hospital — Wuhan, Hubei
- Hunan Cancer Hospital — Changsha, Hunan
- The First Affiliated Hospital of Nanchang University - Donghu District — Nanchang, Jiang
- Linyi Cancer Hospital — Linyi, Shandong
- Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality
- West China Hospital, Sichuan University — Chengdu, Sichuan
- Sir Run Run Shaw Hospital - Zhejiang University School of Med — Hangzhou, Zhejiang
- The First Affiliated Hospital - Zhejiang University School of Medicine — Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang
- Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang
- Beijing Cancer Hospital, Beijing, China — Beijing,
- Shanghai Chest Hospital, Shanghai, China — Shanghai,
- Shanghai Zhongshan Hospital, Shanghai, China — Shanghai,
📞 Contact the Study Coordinator
Phone: +86 021-50720081
Email: clinical_trial@tyligand.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.