Trial Title:
A Study of ST-1898 for Unresectable or Metastatic Melanoma
NCT ID:
NCT06359860
Condition:
Unresectable or Metastatic Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
ST-1898
Melanoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ST-1898 tablets
Description:
Supplied as 5 mg and 40 mg tablets
Arm group label:
ST-1898 Phase II
Arm group label:
ST-1898 Phase Ib
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >= 18 years
- Life expectancy of three months or more
- Histologically or cytologically confirmed unresectable or metastatic stage III or IV
melanoma that was progressed with conventional therapy
- Recommendation of subjects offering archived tissue sample or previous gene test
report;
- Eastern Cooperative Oncology Group performance status (PS) ≤ 1
- At least one measurable lesion per RECIST 1.1
- Has adequate organ function defined as follows:
1. Absolute neutrophil count ≥ 1.5 ×109/L, Platelets ≥ 90 × 109/L and Hemoglobin ≥
90 g/L ( no blood transfusions and no use of CSF within 2 weeks prior to
routine blood test) at screening;
2. Serum creatinine ≤1.5 × upper limit of normal (ULN)
3. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 ULN,
AST/ALT ≤ 5 ULN for liver metastasis;
4. Total bilirubin ≤ 1.5 ULN
5. International normalized ratio (INR) ≤ 1.5 ULN, or prothrombin time (PT) ≤1.5
ULN
6. Activated partial thromboplastin time (APTT) ≤1.5 ULN
7. 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
Exclusion Criteria:
- 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 history 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 or
specialist, 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 third interstitial effusion within 7 days
prior to first dose;
- Subjects with previous or currently malignant tumors (not including non-melanoma
skin cancer, breast cancer or cervical cancer in situ, and superficial bladder
transient cell carcinoma under control in the last 5 years)
- 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 gastritis/duodenal ulcer or esophageal varices)
- A history of concomitant medication with strong inducers or inhibitors of CYP3A4
within 2 weeks prior to first dose;
- 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≤the lower limit of the
reference range (for subjects with positive HBsAg but HBV-DNA titer eligible,
prophylactic antiviral therapy except interferon are allowed); active hepatitis C
(antibody positive)；
- Subjects with acute bacterial, viral or fungal infections, and in needs of systemic
antimicrobial therapy;
- Subjects with positive HIV antibodies or Treponema pallidum antibodies;
- 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, hepatography, 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital & Institute
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun GUO, MD
Phone:
0086-10-88121122
Email:
guoj307@126.co
Contact backup:
Last name:
Chuanliang CUI, MD
Phone:
0086-10-88196348
Email:
1008ccl@163.com
Investigator:
Last name:
Jun GUO, MD
Email:
Principal Investigator
Start date:
November 7, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Beijing Scitech-Mq Pharmaceuticals Limited
Agency class:
Industry
Source:
Beijing Scitech-Mq Pharmaceuticals Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06359860
