A Study to Evaluate Safety, PK and Efficacy of GH55 in Combination With GH21 in Patients With Solid Tumors

Starting soon · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor Cancer

In brief

GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1/2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1/2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly activated RTK MAPK signaling pathway, as well as complementation of resistance mechanisms. This study will evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of GH55 Capsule in combination with GH21 Capsule in patients with advanced solid tumors with aberrantly activated MAPK signaling pathway, and investigate the efficacy of this combination regimen in the same patient population.

Key facts

Study ID

NCT07446725

Run by

Suzhou Genhouse Bio Co., Ltd.

People needed

152

Starts

2026-02-24

Expected to finish

2029-12-31

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Aged 18-80 years (inclusive), regardless of gender.
• 2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor with aberrantly activated MAPK signaling pathway (RAS/RAF/MEK/ERK).
• 3. Failed standard treatment, has no standard treatment options, refuses standard treatment, or is not eligible for standard treatment at the current stage.
• 4. Has at least one measurable tumor lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• 6. Estimated survival time ≥ 3 months.
• 7. Essential organ function is basically normal, with screening laboratory results meeting the following criteria:
• Hematological system (no blood transfusion or hematopoietic stimulants within 14 days)
• Absolute Neutrophil Count (ANC) ≥1.5×109/L
• Platelet (PLT) ≥75×109/L
• Hemoglobin (Hb) ≥90g/L
• Liver function
• Albumin (ALB) ≥3.0g/dL
• Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN); <br/>For patients with --Gilbert syndrome: ≤3×ULN
• Alanine Aminotransferase (ALT) ≤2.5×ULN; <br/>For patients with liver metastasis or liver cancer: ≤5×ULN
• Aspartate Aminotransferase (AST) ≤2.5×ULN; <br/>For patients with liver metastasis or liver cancer: ≤5×ULN
• Renal function
• Creatinine (Cr) ≤1.5×ULN
• Creatinine Clearance (Ccr) ≥50ml/min (calculated by Cockcroft-Gault formula)
• Coagulation function
• Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN
• International Normalized Ratio (INR) ≤1.5×ULN
• Cardiac function
• Left Ventricular Ejection Fraction (LVEF) ≥50%
• Fridericia-corrected QT interval (QTcF) Male<450ms; Female<470ms

You may not qualify if…

• 1. Received chemotherapy within 3 weeks, or radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before the first dose, except:
• - Nitrosourea or mitomycin C: within 6 weeks before the first dose;
• - Oral fluoropyrimidines, small-molecule targeted drugs, or traditional Chinese medicine with anti-tumor indications: within 2 weeks before the first dose;
• - Local palliative radiotherapy: within 2 weeks before the first dose.
• 2. Received other unmarketed clinical research drugs or treatments within 4 weeks before the first dose.
• 3. Underwent major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before the first dose.
• 4. Used strong inhibitors or inducers of CYP3A4 or P-gp within 1 week before the first dose.
• 5. Previously received other selective ERK inhibitors and/or SHP2 inhibitors.
• 6. Previously received hematopoietic stem cell transplantation or organ transplantation.
• 7. Adverse reactions from previous anti-tumor treatment have not recovered to NCI CTCAE v5.0 Grade ≤ 1 (except for toxicities judged by investigators to be safe, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism stabilized with hormone replacement therapy).
• 8. Symptomatic parenchymal brain metastasis or meningeal metastasis, deemed unsuitable for enrollment by investigators.
• 9. Has an active infection requiring intravenous anti-infective treatment.
• 10. Has a history of immunodeficiency, including positive HIV antibody test.
• 11. Active hepatitis B (HBsAg positive and HBV-DNA > 500 IU/ml, 1000 cps/ml, or the study center's lower limit of detection [if higher]); antiviral therapy (excluding interferon) is allowed. Active hepatitis C (patients with positive HCV antibody but HCV-RNA < the study center's lower limit of detection are eligible).
• 12. Has a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
• - Severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block);
• - Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardiovascular and cerebrovascular events within 6 months before the first dose;
• - New York Heart Association (NYHA) cardiac function class ≥ III;
• - Clinically uncontrolled hypertension;
• - Any factors increasing the risk of QTc prolongation or arrhythmia (e.g., heart failure, intractable hypokalemia, congenital long QT syndrome, family history of long QT syndrome, use of any known drugs that prolong the QT interval [see Appendix 8]).
• 13. Has a history of other malignant tumors (except cured in situ cancers with no recurrence for 5 years, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, as deemed eligible by investigators; eligible in the dose escalation phase at the discretion of investigators).
• 14. Has a history of retinal vein occlusion or central serous chorioretinopathy.
• 15. Unable to swallow oral medications, or has conditions severely affecting gastrointestinal absorption (e.g., chronic diarrhea, intestinal obstruction) as judged by investigators.
• 16. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).
• 17. Has a history of interstitial pneumonia within 6 months before the first dose, or any evidence of clinically active interstitial lung disease.

Where it is running

• Shanghai Goboard Cancer Hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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