Actively Recruiting
GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results
Led by Suzhou Genhouse Bio Co., Ltd. · Updated on 2024-07-08
110
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
Sponsors
S
Suzhou Genhouse Bio Co., Ltd.
Lead Sponsor
S
Shanghai East Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years (inclusive)
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors with MAPK mutations (RAS/RAF/MEK/ERK)
- Patients who have failed standard treatments, have no standard treatment options, or are unsuitable for standard treatment
- At least one assessable tumor lesion per RECIST 1.1 for dose escalation; at least one measurable lesion for dose expansion
- ECOG performance status 0-1 for phase I dose escalation; 0-2 for phase II dose expansion
- Expected survival of 3 months or longer
- Normal major organ function with specific lab criteria during screening (hematological, liver, renal, coagulation, cardiac)
- Agreement to use reliable contraception during the study and for 3 months after last dose if of childbearing potential
- Negative pregnancy test within 1 week before first dose for females of childbearing potential
- Signed informed consent form voluntarily
You will not qualify if you...
- Received chemotherapy within 3 weeks or radiotherapy, biotherapy, endocrine, targeted, or immunotherapy within 4 weeks before first dose, with some exceptions
- Received other investigational drugs within 4 weeks before first dose
- Major organ surgery or significant trauma within 4 weeks before first dose or requiring surgery during study
- Use of strong CYP3A4 inhibitors or inducers within 1 week before first dose
- Previous treatment with selective ERK inhibitors
- Prior allogeneic hematopoietic stem cell transplant or organ transplant
- Unresolved adverse reactions from prior antitumor therapy above grade 1 except certain stable conditions
- Brain or meningeal metastases with symptoms unsuitable for participation
- Active infection requiring intravenous antibiotics
- History of immunodeficiency including positive HIV test
- Active hepatitis B or C not controlled per study criteria
- Severe cardiovascular or cerebrovascular diseases, uncontrolled hypertension, or risk factors for QT prolongation
- History of other recent malignant tumors unless deemed acceptable
- Significant eye disorders or retinal diseases
- Unable to swallow medication or with severe gastrointestinal absorption issues
- Clinically uncontrolled third space effusion
- Current interstitial lung disease except stable radiation-induced fibrosis
- Known alcohol or drug dependence
- Mental disorder or poor compliance
- History of severe allergy or allergy to study drug ingredients
- Pregnant or breastfeeding women
- Other conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
Research Team
Y
YIMING ZHOU, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here