Actively Recruiting
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Led by Beijing Scitech-Mq Pharmaceuticals Limited · Updated on 2025-08-24
64
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma. In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy. In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets.
CONDITIONS
Official Title
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Life expectancy of three months or more
- Confirmed unresectable or metastatic stage III or IV acral melanoma that has progressed despite conventional therapy
- Willingness to provide archived tumor tissue or previous biomarker test report; fresh biopsy allowed if archived tissue is unavailable
- Eastern Cooperative Oncology Group performance status of 0 or 1
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Adequate organ function including: absolute neutrophil count 1.5 x 10^9/L, platelets 75 x 10^9/L, hemoglobin 90 g/L without recent transfusions or colony stimulating factor, serum creatinine 1.5 times upper limit of normal, AST/ALT 2.5 times upper limit of normal (or 5 times for liver metastasis), total bilirubin 1.5 times upper limit of normal, INR or prothrombin time 1.5 times upper limit of normal, activated partial thromboplastin time 1.5 times upper limit of normal, serum albumin 30 g/L
- Willing and able to provide written informed consent
- Use of effective contraception during the study and for 90 days after last treatment; women of childbearing potential must have a negative pregnancy test within 7 days prior to first treatment
You will not qualify if you...
- Antitumor therapy within 4 weeks prior to first dose, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, or immunotherapy
- Use of oral fluoropyrimidines or small molecule targeted drugs within 2 weeks or 5 half-lives before first dose
- Use of traditional Chinese medicine with antitumor effects within 2 weeks prior to first dose
- Participation in other clinical trials of unapproved drugs within 4 weeks
- Major surgery or severe trauma within 4 weeks prior to first dose, excluding tumor biopsy, puncture, or invasive dental procedures
- Current or previous severe retinopathy deemed unsuitable for enrollment
- History of significant cardiovascular or cerebrovascular disease including severe arrhythmia, QTc prolongation, major cardiovascular events within 6 months, congestive heart failure, uncontrolled hypertension, or left ventricular ejection fraction below 50%
- Active leptomeningeal disease or poorly controlled brain metastases except stable asymptomatic or treated brain metastases
- Interstitial lung disease or radiation pneumonia requiring corticosteroids
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Malignant tumors within the last 5 years except certain skin, breast, cervical, or bladder cancers
- History of severe bleeding episodes or current significant hemorrhage with high bleeding risk
- Use of strong CYP3A4 inducers, inhibitors, or narrow therapeutic substrates within 2 weeks
- Grade 2 or higher toxicities from previous therapies except tolerable peripheral neuropathy or alopecia
- Active hepatitis B or C infection, except controlled HBV with prophylactic antiviral therapy
- Positive HIV or Treponema pallidum antibodies
- Active infections requiring systemic antimicrobial therapy
- Pregnant or lactating females
- Significant neuropsychiatric disorders affecting compliance
- Underlying diseases or substance abuse affecting safety evaluation
- Inability to take oral medication or malabsorption conditions
- Significant liver cirrhosis, hepatatrophy, portal hypertension, or moderate to severe ascites
- History of organ transplant
- Other severe systemic diseases or conditions deemed unsuitable by investigator
- Live vaccine within 28 days prior to first dose except inactivated influenza and COVID-19 vaccines; mRNA COVID-19 vaccines and intranasal influenza vaccines not allowed
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, China, 100142
Actively Recruiting
Research Team
J
Jun GUO, MD
CONTACT
C
Chuanliang CUI, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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