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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
China
Peking University Cancer Hospital & Institute
RECRUITING
Beijing
Contact Information
Primary
Jun GUO, MD
guoj307@126.com
086-10-88121122
Backup
Chuanliang CUI, MD
1008ccl@163.com
0086-10- 88196348
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 64
Treatments
Experimental: ST-1898 Phase Ib
Dose Escalation: Subjects will be administered orally at 140mg, 160mg, 180mg, 220mg, QD during the study, until disease progression or intolerable toxicity.
Experimental: ST-1898 Phase II
Dose 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.
Related Therapeutic Areas
Sponsors
Leads: Beijing Scitech-Mq Pharmaceuticals Limited

This content was sourced from clinicaltrials.gov

Similar Clinical Trials