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Unresectable or Metastatic MelanomaPhase 1/2NCT06359860

A Study of ST-1898 for Unresectable or Metastatic Melanoma

A Phase 1/2 study testing ST-1898 tablets in people with Unresectable or Metastatic Melanoma, run by Beijing Scitech-Mq Pharmaceuticals Limited at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable or Metastatic Melanoma
What is being tested?
ST-1898 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
7 Nov 2023to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 needle biopsy (fine needle biopsy not allowed)
  • Eastern Cooperative Oncology Group performance status (PS) ≤ 1
  • At least one measurable lesion per RECIST 1.1
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  • 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
  • Willing and able to provide written Informed consent.
  • 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

Who cannot join

  • 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;
  • 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.
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  • 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 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)
  • 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；
  • Subjects with interstitial lung disease or radiation pneumonia in needs of corticosteroids therapy
  • Subjects with clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 7 days prior to first dose;
  • 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)
  • 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)
  • 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;
  • 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);
  • 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)；
  • Subjects with positive HIV antibodies or Treponema pallidum antibodies;
  • Subjects with acute bacterial, viral or fungal infections, and in needs of systemic antimicrobial therapy;
  • Pregnant or lactating females;
  • Subjects with significant neuropsychiatric disorders, leading to poor compliance;
  • 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;
  • Subjects with oral administration impossible, or in the conditions of malabsorption as determined by the investigator, such as dysphagia and intestinal obstruction, etc.;
  • Subjects 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 mRNA vaccines are not allowed. Intranasal influenza vaccines are live vaccines and are not allowed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital & Institute

    Beijing, 100142

Other trials in China

About this study

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

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.

Being tested
ST-1898 tablets
Keywords
ST-1898, Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ST-1898 tabletsDrug

    Supplied as 5 mg and 40 mg tablets

Study groups in NCT06359860
Study groupRoleWhat they receive
ST-1898 Phase IbExperimentalDose Escalation: Subjects will be administered orally at 140mg, 160mg, 180mg, 220mg, QD during the study, until disease progression or intolerable toxicity.
Receives: Drug: ST-1898 tablets
ST-1898 Phase IIExperimentalDose Expansion: Subjects with unresectable or metastatic melanoma will be administered orally at recommended phase II dose from phase Ib once daily during the study, until disease progression or intolerable toxicity.
Receives: Drug: ST-1898 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs)

    AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0

    Measured: Approximately 18 months

  2. Phase Ib Dose Escalation: Recommended Phase 2 Dose (RP2D)

    RP2D was determined according to MTD. MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first cycle (21days) of treatment.

    Measured: Within the first cycle (21days)

  3. Phase II Expansion: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who experience a CR or PR based on RECIST 1.1 (CR: Complete Response, Disappearance of all target lesions, PR: Partial Response, At least a 30% decrease in the sum of diameters of target lesions)

    Measured: Approximately 18 months

Secondary outcomes (14)

  1. Phase Ib Dose Escalation: Trough concentration of ST-1898

    To assess plasma pharmacokinetics (PK) of oral administration of ST-1898

    Measured: Cycle 1 Day 1, Cycle 1 Day 21, Cycle 3 Day 1 during Phase Ib Dose Escalation (21 days per cycle), up to 10 weeks

  2. Phase Ib Dose Escalation: Peak concentration of ST-1898

    To assess plasma pharmacokinetics (PK) of oral administration of ST-1898

    Measured: Cycle 1 Day 1, Cycle 1 Day 21, Cycle 3 Day 1 during Phase Ib Dose Escalation (21 days per cycle), up to 10 weeks

  3. Phase Ib Dose Escalation: ORR

    Objective Response Rate (ORR) per RECIST 1.1

    Measured: Approximately 18 months

  4. Phase Ib Dose Escalation: PFS

    Progression-Free Survival (PFS) per RECIST 1.1

    Measured: Approximately 18 months

  5. Phase Ib Dose Escalation: DoR

    DoR Duration of Response (DoR) per RECIST 1.1

    Measured: Approximately 18 months

  6. Phase Ib Dose Escalation: DCR

    Disease Control Rate (DCR) per RECIST 1.1

    Measured: Approximately 18 months

  7. Phase Ib Dose Escalation: TTP

    Time to Progression per RECIST 1.1

    Measured: Approximately 18 months

  8. Phase II Dose Expansion: The Number and frequency of treatment-related adverse events and serious adverse events (SAEs)

    The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.

    Measured: Approximately 18 months

  9. Phase II Dose Expansion: Trough concentration of ST-1898

    To assess plasma Trough concentration of oral administration of ST-1898 in subjects with unresectable or metastatic melanoma

    Measured: Cycle 1 Day 1, Cycle 1 Day 21, Cycle 3 Day 1 during Phase II Dose Expansion (21 days per cycle), up to 10 weeks

  10. Phase II Dose Expansion: Peak concentration of ST-1898

    To assess plasma Peak concentration of oral administration of ST-1898 in subjects with unresectable or metastatic melanoma

    Measured: Cycle 1 Day 1, Cycle 1 Day 21, Cycle 3 Day 1 during Phase II Dose Expansion (21 days per cycle), up to 10 weeks

  11. Phase II Dose Expansion: PFS

    Progression-Free Survival (PFS) per RECIST 1.1

    Measured: Approximately 18 months

  12. Phase II Dose Expansion: DoR

    DoR Duration of Response (DoR) per RECIST 1.1

    Measured: Approximately 18 months

  13. Phase II Dose Expansion: DCR

    Disease Control Rate (DCR) per RECIST 1.1

    Measured: Approximately 18 months

  14. Phase II Dose Expansion: TTP

    Time to Progression per RECIST 1.1

    Measured: Approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start7 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359860
Sponsor's protocol ID
ST-1898-203
Status last verified
Nov 2026
First submitted
3 Jan 2024
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ST-1898 tablets in people with Unresectable or Metastatic Melanoma, run by Beijing Scitech-Mq Pharmaceuticals Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs) (time frame: Approximately 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06359860.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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