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NCT06385925 · ClinicalTrials.gov registry record · Phase 1
A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
A Phase 1 study of Malignant Neoplasm, sponsored by Tyligand Pharmaceuticals (Suzhou) Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 440
- Enrollment target
- 19
- Study locations
NCT06385925 is a Phase 1 study of Malignant Neoplasm that is actively recruiting participants, run by Tyligand Pharmaceuticals (Suzhou) Limited. The registered enrollment target is 440 participants, below the 506-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (13% lower). The trial reports 19 study locations across 13 states.
The verdict
NCT06385925, a Phase 1 study of Malignant Neoplasm, is actively recruiting participants, sponsored by Tyligand Pharmaceuticals (Suzhou) Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 440 participants
- Enrollment target
- 19
- Study locations
Study 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. 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.
Conditions Studied
Interventions
- DRUG TSN1611
Study Locations (19)
Zhejiang
- Sir Run Run Shaw Hospital - Zhejiang University School of Med - Hangzhou
- The First Affiliated Hospital - Zhejiang University School of Medicine - Hangzhou
- The Second Affiliated Hospital of Zhejiang University School of Medicine - Hangzhou
- Taizhou Hospital of Zhejiang Province - Taizhou
Other
- Beijing Cancer Hospital, Beijing, China - Beijing
- Shanghai Chest Hospital, Shanghai, China - Shanghai
- Shanghai Zhongshan Hospital, Shanghai, China - Shanghai
Texas
- MD Anderson Cancer Center - Houston
- NEXT Oncology - San Antonio
Virginia
- NEXT Virginia - Fairfax
Anhui
- Anhui Provincial Cancer Hospital - Hefei
Beijing Municipality
- Beijing Cancer Hospital - Beijing
Guangdong
- The First Affiliated Hospital of Guangzhou Medical University - Guangzhou
Hubei
- Hubei Cancer Hospital - Wuhan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06385925
The ClinicalTrials.gov registry entry for NCT06385925 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 506-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (13% lower). The listed sponsor is Tyligand Pharmaceuticals (Suzhou) Limited, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malignant Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which TSN1611 is the first listed.
NCT06385925 reports 19 study locations spanning 13 distinct geographic areas - top geographies include Zhejiang, Other, Texas.
Frequently Asked Questions
What is clinical trial NCT06385925 about?
NCT06385925 is a clinical study titled "A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation". 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) thr...
What is the current status of trial NCT06385925?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 440 participants. The study started on 2024-04-29. Estimated completion is 2027-04-30.
What conditions does trial NCT06385925 study?
This clinical trial studies the following conditions: Malignant Neoplasm.
What interventions are being tested in trial NCT06385925?
The interventions under investigation include: TSN1611 (DRUG).
Who is sponsoring clinical trial NCT06385925?
This trial is sponsored by Tyligand Pharmaceuticals (Suzhou) Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06385925 being conducted?
This trial has 19 study locations across Texas, Virginia, Anhui, Beijing Municipality, Guangdong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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