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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study of ST-1898 for Unresectable or Metastatic Melanoma

A Phase Ib/II Study to Evaluate the Efficacy and Safety of ST-1898 in Subjects With Unresectable or Metastatic Melanoma

A Study of ST-1898 for Unresectable or Metastatic Melanoma (NCT06359860) is a Phase 1 / Phase 2 interventional studying Unresectable or Metastatic Melanoma, sponsored by Beijing Scitech-Mq Pharmaceuticals Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Unresectable or Metastatic Melanoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 64 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Unresectable or Metastatic Melanoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age \>= 18 years 2. Life expectancy of three months or more 3. diagnosed by tissue sample (biopsy-confirmed) unresectable or metastatic stage III or IV acral melanoma that was progressed with conventional therapy 4. 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 needle biopsy (fine needle biopsy not allowed) 5. Eastern Cooperative Oncology Group performance status (PS) ≤ 1 6. At least one measurable lesion per RECIST 1.1 7. Has your organs (liver, kidneys, etc.) are working well enough based on blood tests defined as follows: - Absolute neutrophil count ≥ 1.5 ×10\^9/L, platelet count at least 75× 10\^9/L and blood count (hemoglobin) at least 90 g/L (no blood transfusions, no platelet transfusions and no use of colony stimulating factor within 2 weeks prior to routine blood test) at screening; - 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 8. Willing and able to provide written willing to sign a consent form. 9. Eligible male and female subjects 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 negative serum pregnancy test within 7 days before first study treatment Exclusion Criteria 1. Subjects 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.; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age \>= 18 years 2. Life expectancy of three months or more 3. Histologically or cytologically confirmed unresectable or metastatic stage III or IV acral melanoma that was progressed with conventional therapy 4. 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 needle biopsy (fine needle biopsy not allowed) 5. Eastern Cooperative Oncology Group performance status (PS) ≤ 1 6. At least one measurable lesion per RECIST 1.1 7. 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 test) at screening; * 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 8. Willing and able to provide written Informed consent. 9. Eligible male and female subjects 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 negative serum pregnancy test within 7 days before first study treatment Exclusion Criteria 1. Subjects 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; 2. A history of being participant in clinical trial of other unapproved drugs within 4 weeks; 3. A major operation or severe trauma within 4 weeks, (except tumor biopsy, puncture,)invasive dental procedures such as dental extraction, dental implants etc. 4. Current or previous severe retinopathy who, in the judgment of the Investigator, are not suitable for enrollment 5. 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 heart failure, or aortic dissection etc.; * New York Heart Association Class ≥ II; * Left ventricular ejection fraction(LVEF)\<50%; * Uncontrolled hypertension (blood pressure≥140/90 mmHg even with antihypertensive therapy) 6. Subjects with active leptomeningeal disease or brain metastases without being well controlled, except subjects with asymptomatic or treated brain metastases being stable imaging between 12 weeks before screening; 7. Subjects with interstitial lung disease or radiation pneumonia in needs of corticosteroids therapy 8. Subjects with clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 7 days prior to first dose; 9. Subjects 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) 10. 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 esophageal varices) 11. 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; 12. Subjects 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); 13. Subjects with active hepatitis B, unless HBV-DNA titer in the normal range (for subjects with positive HBsAg but HBV-DNA titer eligible, prophylactic antiviral therapy except interferon is allowed); active hepatitis C (ANTI-HCV positive); 14. Subjects with positive HIV antibodies or Treponema pallidum antibodies; 15. Subjects with acute bacterial, viral or fungal infections, and in needs of systemic antimicrobial therapy; 16. Pregnant or lactating females; 17. Subjects with significant neuropsychiatric disorders, leading to poor compliance; 18. Subjects 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; 19. Subjects with oral administration impossible, or in the conditions of malabsorption as determined by the investigator, such as dysphagia and intestinal obstruction, etc.; 20. Subjects with significant liver cirrhosis, hepatatrophy, portal hypertension, or more than moderate volume of ascites; 21. A history of organ transplant; 22. A history of other severe systemic disease, or not suitable as determined by the investigator due to any other reasons; 23. 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 mRNA vaccines are not allowed. Intranasal influenza vaccines are live vaccines and are not allowed.

Treatments Being Tested

DRUG

ST-1898 tablets

Supplied as 5 mg and 40 mg tablets

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University Cancer Hospital & Institute
Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06359860), the sponsor (Beijing Scitech-Mq Pharmaceuticals Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06359860 clinical trial studying?

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 objec… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06359860?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06359860?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06359860. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06359860. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.