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Tests treatment safety and results for Advanced Solid Tumors With MAPK Signal Pathway Mutations
Official title GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results
ClinicalTrials.gov ID: NCT06310382
What this study is testing
What is GH55?
GH55 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors with mapk signal pathway mutations.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people must meet all the following to be qualified for study enrollment:
- Male or female people 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...
- 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...
You likely can't join if
- people who meet any one of the following exclusion criteria are not eligible for study enrollment:
- Received antitumor therapy such as chemotherapy within 3 weeks before the first dose, radiotherapy, biotherapy, endocrine therapy, targeted therapy...
- 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...
- 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.
See the full eligibility criteria
Who can join
- people must meet all the following to be qualified for study enrollment:
- Male or female people 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...
- Eastern Cooperative Oncology Group (ECOG) performance status score: Phase I dose escalation: 0-1. Phase II dose expansion: 0-2.
- 3 months or longer expected survival.
- Major organs are functioning normally, and laboratory tests meet the following criteria during the screening period. Hematological system (has not received any blood transfusion or hematopoietic stimulating factor...
What rules you out
- people who meet any one of the following exclusion criteria are not eligible for study enrollment:
- Received antitumor therapy such as chemotherapy within 3 weeks before the first dose, radiotherapy, biotherapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks before the first dose, except for the...
- 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.
- Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first dose or requires selective surgery during the study period.
- Use of strong CYP3A4 inhibitors or inducers within 1 week prior to the first dose of the investigational drug.
- Previously received other selective ERK inhibitors.
- Previously received allogeneic HSCT or organ transplantation.
- Adverse drug reactions of previous antitumor treatment have not recovered to grade ≤ 1 as per CTCAE version 5.0 (except for toxicity without safety risk judged by the investigator, such as alopecia, grade 2 peripheral...
- Brain parenchymal metastasis or meningeal metastasis with clinical symptoms unsuitable for study participation as judged by the investigator.
- Patient with active infection and currently requires intravenous anti-infective therapy.
- History of immunodeficiency, including being positive for HIV antibody test.
- Active hepatitis B [HBsAg positive and HBV-DNA \> 500 IU/mL or LLQ of the study site (when the LLQ is \> 500 IU/mL)], for which antiviral therapies other than interferon are permitted; Active hepatitis C (patients who...
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Severe abnormalities in cardiac rhythm or conduction, such as ventricular arrhythmia or second- or third-degree atrioventricular block requiring clinical intervention;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or greater cardiovascular and cerebrovascular events within 6 months prior to the first dose;
- New York Heart Disease Association (NYHA) class ≥ III cardiac function or left ventricular ejection fraction (LVEF) \< 50%;
- Clinically uncontrolled hypertension;
- Any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia that is difficult to correct, congenital long QT syndrome, family history of long QT syndrome, and use of...
- History of other malignant tumors (except for the cured squamous cell carcinoma in situ of the skin, basal cell carcinoma, and cervical carcinoma in situ that have not recurred within 5 years and are considered...
- History of retinal vein occlusion or central serous retinopathy, or patients with clinically significant abnormalities in the ophthalmological examination during the screening period and judged by the investigator to be...
- Unable to swallow medication or has conditions that severely impact gastrointestinal absorption (e.g. Chronic diarrhea or intestinal obstruction) as judged by the investigator.
- Clinically uncontrolled third space effusion judged by the investigator to be unsuitable for enrollment.
- Patients with current interstitial lung disease (except radiation-induced pulmonary fibrosis that does not required hormone therapy).
- Known alcohol or drug dependence.
- Mental disorder or poor compliance.
- Previous history of severe allergy, or allergy to any active or non-active ingredients of the investigational drug.
- Pregnant or lactating women.
- Other conditions judged by the investigator that render the subject unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.