GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Genhouse Bio Co., Ltd.
About this trial
This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.
This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study.
Eligibility criteria
Qualifiers
Male or female subjects aged 18-80 years (inclusive).
Patients with histologically or cytologically confirmed MAPK mutant (presence of RAS/RAF/MEK/ERK mutations) locally advanced or metastatic solid tumors.
Patients who have failed standard treatment or have no standard treatment regimen or are not suitable for standard treatment currently.
Dose escalation: At least one assessable tumor lesion according to RECIST version 1.1; Dose expansion: At least one measurable tumor lesion according to RECIST version 1.1 (tumor lesion located in the region of previous radiotherapy or other locoregional treatment sites is usually not considered a measurable lesion, unless this lesion shows clear progression or persists for 3 months after radiotherapy).
Disqualifiers
Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
Use of oral fluorouracil(s), small molecule targeted drugs, and antitumor traditional Chinese medicine within 2 weeks prior to the first dose of the investigational drug;
Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational drug.
Received other unmarketed clinical investigational drug or therapy within 4 weeks prior to the first dose.
Trial design
Treatments tested in this trial
- GH55
Treatment groups
110 Participants
are divided into 1 treatment groupSponsors and collaborators
Suzhou Genhouse Bio Co., Ltd.
Lead sponsor
Shanghai East Hospital
Collaborator
Shandong Tumor Hospital
Collaborator
Source ClinicalTrials.gov