CI

At a glance

ClinicalIndex Comparison Record
Phase 1Unknown· 70 target
Drug / intervention
GEC255 tabletsdrug
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/NCT05768321
NCT05768321Phase 1Unknown
CompareCT.gov

A Phase 1 Open-Label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of GEC255 Oral Tablets in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

GenEros Biopharma Hangzhou Ltd·interventional·Posted Mar 14, 2023·Updated Mar 16, 2023

In Brief

A Phase 1 clinical trial evaluating GEC255 tablets for Advanced Solid Tumors. Targeting 70 participants across 1 site.

Detailed Summary

The overall objective of this Phase 1 study is to evaluate the safety, Pharmacokinetics (PK), and anti-tumor activity of daily oral dosing with GEC255 tablets in subjects with advanced solid tumor with Kirsten Rat Sarcoma (KRAS) p.G12C mutation. To determine the recommended Phase 2 dose (RP2D) based on assessments of multiple dose escalation and expansion in target cohorts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesChina
Collaborators--

Timeline

Phase 1UnknownOverdue
20222023202420252026
First PostedMar 14, 2023
Enrollment StartNov 4, 2021
Primary CompletionFeb 28, 2024
Study CompletionMay 30, 2024
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 3.3 years ago

Interventions

GEC255 tabletsdrug

Part 1: Dose escalation After initial starting dose cohort, daily dosages in subsequent cohorts are determined by cohort review committee. Part 2: Dose expansion Daily oral dosage RP2D based on data from Part 1