CI

At a glance

ClinicalIndex Comparison Record
Phase 1Unknown· 243 target
Drug / intervention
SIM1803-1Adrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04671849
NCT04671849Phase 1Unknown
CompareCT.gov

An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.

Jiangsu Simcere Pharmaceutical Co., Ltd.·interventional·Posted Dec 17, 2020·Updated Jan 13, 2021

In Brief

A Phase 1 clinical trial evaluating SIM1803-1A for Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion. Targeting 243 participants across 1 site.

Detailed Summary

This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). SIM1803-1A is a drug that blocks the actions of these NTRK/ ROS1 /ALK genes in cancer cells and can therefore be used to treat cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
CountriesChina
Collaborators--

Timeline

Phase 1UnknownOverdue
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartDec 21, 2020
Primary CompletionSep 30, 2022
Study CompletionJan 30, 2024
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 5.5 years ago

Interventions

SIM1803-1Adrug

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.