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Recruiting Phase 1 NCT07110883

A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

Trial Parameters

Condition Advanced Solid Tumor
Sponsor CSPC Megalith Biopharmaceutical Co.,Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-15
Completion 2026-10-31
Interventions
SYS6023

Brief Summary

This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years; 2. Histologically and/or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumor; 3. Sufficient archived or fresh tumor tissue samples must be provided for HER3 testing, among others; 4. Medical documentation must be provided before the first dose to clarify the following molecular typing information: HER2, HR receptor (including estrogen receptor (ER) and progesterone receptor (PR) ) expression for breast cancer participants, and Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) fusion, ROS Proto-Oncogene 1, receptor tyrosine kinase (ROS1) fusion, B-Raf Proto-Oncogene, serine/threonine kinase (BRAF) V600 mutation, Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, Neurotrophic Tyrosine Receptor Kinase (RET) rearrangement, HER2 mutation, MET Proto-Oncogene(Met)exon14 skipping mutation, Met amplification, KRAS Proto-Oncogene, GTPase G12C(KRAS G12c) mutation status for non-small ce

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