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New treatment option for Unresectable or Metastatic Melanoma
Official title A Study of ST-1898 for Unresectable or Metastatic Melanoma
ClinicalTrials.gov ID: NCT06359860
What this study is testing
What is ST-1898 tablets?
ST-1898 tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for unresectable or metastatic melanoma.
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
- 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.
- 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 and older
You may be able to join if
- Age \>= 18 years
- Life expectancy of three months or more
- Histologically or cytologically confirmed unresectable or metastatic stage III or IV acral melanoma that was progressed with conventional therapy
- Recommendation of subject offering archived tissue sample or previous biomarker test report. If archived tumor sample is not available, a fresh...
- Eastern Cooperative Oncology Group performance status (PS) ≤ 1
You likely can't join if
- people with one of the following conditions prior to first dose, including, but not limiting to：
- A history of antitumor therapy within 4 weeks, including chemotherapy, radiotherapy, biotherapy, endocrine therapy or immunotherapy, etc.;
- A history of oral fluoropyrimidines and small molecular targeted-drug therapy within 2 weeks or 5 half-life time （the longer time taken as final）;
- A history of traditional Chinese medicine with antitumor indication within 2 weeks;
- A history of being participant in clinical trial of other unapproved drugs within 4 weeks;
- A major operation or severe trauma within 4 weeks, （except tumor biopsy, puncture,）invasive dental procedures such as dental extraction, dental...
See the full eligibility criteria
Who can join
- Age \>= 18 years
- Life expectancy of three months or more
- Histologically or cytologically confirmed unresectable or metastatic stage III or IV acral melanoma that was progressed with conventional therapy
- Recommendation of subject offering archived tissue sample or previous biomarker test report. If archived tumor sample is not available, a fresh biopsy is optional, which need to be taken from needle biopsy or core...
- Eastern Cooperative Oncology Group performance status (PS) ≤ 1
- At least one measurable lesion per RECIST 1.1
- Has adequate organ function defined as follows:
- Absolute neutrophil count ≥ 1.5 ×10\^9/L, Platelets ≥ 75× 10\^9/L and Hemoglobin ≥ 90 g/L (no blood transfusions, no platelet transfusions and no use of colony stimulating factor within 2 weeks prior to routine blood...
- Serum creatinine ≤1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 ULN, AST/ALT ≤ 5 ULN for liver metastasis;
- Total bilirubin ≤ 1.5 ULN
- International normalized ratio (INR) ≤ 1.5 ULN, or prothrombin time (PT) ≤1.5 ULN
- Activated partial thromboplastin time (APTT) ≤1.5 ULN
- Serum albumin ≥30 g/L
- Willing and able to provide written Informed consent.
- Eligible male and female people with fertility activity or their sexual partners must use effective contraception during study period and though 90 days after last study treatment. Women of child-bearing age must have a...
What rules you out
- people with one of the following conditions prior to first dose, including, but not limiting to：
- A history of antitumor therapy within 4 weeks, including chemotherapy, radiotherapy, biotherapy, endocrine therapy or immunotherapy, etc.;
- A history of oral fluoropyrimidines and small molecular targeted-drug therapy within 2 weeks or 5 half-life time （the longer time taken as final）;
- A history of traditional Chinese medicine with antitumor indication within 2 weeks;
- A history of being participant in clinical trial of other unapproved drugs within 4 weeks;
- A major operation or severe trauma within 4 weeks, （except tumor biopsy, puncture,）invasive dental procedures such as dental extraction, dental implants etc.
- Current or previous severe retinopathy who, in the judgment of the Investigator, are not suitable for enrollment
- A history of clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:
- Severe arrhythmia or heart conduction disturbance, such as second-degree or third-degree atrio-ventricular block or ventricular arrhythmia indicated with medical intervention
- QTc (by Fridericia): male \>450 ms, female \>470 ms
- Major cardiovascular events within 6 months prior to first dose, including acute coronary syndrome, stroke, deep vein thrombosis, pulmonary-thromboembolism and other ≥Grade 3 arterial-thrombosis events, or congestive...
- New York Heart Association Class ≥ II；
- Left ventricular ejection fraction（LVEF）\<50%；
- Uncontrolled hypertension (blood pressure≥140/90 mmHg even with antihypertensive therapy)
- people with active leptomeningeal disease or brain metastases without being well controlled, except people with asymptomatic or treated brain metastases being stable imaging between 12 weeks before screening；
- people with interstitial lung disease or radiation pneumonia in needs of corticosteroids therapy
- people with clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 7 days prior to first dose;
- people with malignant tumors in the last 5 years (not including non-melanoma skin cancer, breast cancer or cervical cancer in situ, and superficial bladder transient cell carcinoma that have been cured)
- A history of ≥ grade 3 bleeding episodes within 6 months prior to first dose; or currently ≥ grade 2 hemorrhage, with angioneoplasm/ vascular malformation, with high bleeding risks (such as active peptic ulcer or...
- Within 2 weeks prior to first dose of concomitant medication with strong inducers of CYP3A4, strong inhibitors of CYP3A4, or substrates with narrow therapeutic windows of CYP3A4;
- people with ≥ Grade 2 (by CTCAE) toxicities caused by previous therapy (not including ≤Grade 2 peripheral neuropathy, alopecia, or other tolerated and no possible safety hazard events as determined by the investigator);
- people with active hepatitis B, unless HBV-DNA titer in the normal range (for people with positive HBsAg but HBV-DNA titer eligible, prophylactic antiviral therapy except interferon is allowed); active hepatitis C...
- people with positive HIV antibodies or Treponema pallidum antibodies;
- people with acute bacterial, viral or fungal infections, and in needs of systemic antimicrobial therapy;
- Pregnant or lactating females;
- people with significant neuropsychiatric disorders, leading to poor compliance;
- people with underlying diseases (including abnormal laboratory investigations), alcohol, drug abuse, or drug dependence, all which affect the interpretation of toxicities or adverse event, or decrease;
- people with oral administration impossible, or in the conditions of malabsorption as determined by the investigator, such as dysphagia and intestinal obstruction, etc.;
- people with significant liver cirrhosis, hepatatrophy, portal hypertension, or more than moderate volume of ascites;
- A history of organ transplant;
- A history of other severe systemic disease, or not suitable as determined by the investigator due to any other reasons;
- A history of inoculation with live vaccine within 28 days prior to first dose. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is permitted. Inactivated COVID-19 vaccines are permitted. COVID-19...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.