A Study of ST-1898 for Unresectable or Metastatic Melanoma

NCT06359860 | Recruiting Phase 1

• 1 other identifier: ST-1898-203
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable or Metastatic Melanoma

Keywords

ST-1898; Melanoma

Outcome Measures

Primary Outcomes (3)

• 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

  Approximately 18 months

• 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.

  Within the first cycle (21days)

• 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)

  Approximately 18 months

Secondary Outcomes (14)

• Phase Ib Dose Escalation: Trough concentration of ST-1898

  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

• Phase Ib Dose Escalation: Peak concentration of ST-1898

  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

• Phase Ib Dose Escalation: ORR

  Approximately 18 months

• Phase Ib Dose Escalation: PFS

  Approximately 18 months

• Phase Ib Dose Escalation: DoR

  Approximately 18 months

Study Arms (2)

ST-1898 Phase Ib

EXPERIMENTAL

Dose Escalation: Subjects will be administered orally at 140mg, 160mg, 180mg, 220mg, QD during the study, until disease progression or intolerable toxicity.

Drug: ST-1898 tablets

ST-1898 Phase II

EXPERIMENTAL

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.

Drug: ST-1898 tablets

Interventions

ST-1898 tablets DRUG

Supplied as 5 mg and 40 mg tablets

ST-1898 Phase II; ST-1898 Phase Ib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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.
• 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；

Sponsors & Collaborators

• Beijing Scitech-Mq Pharmaceuticals Limited: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

3-(3'-adamantan-1-yl-4'-methoxybiphenyl-4-yl)-2-propenoic acid

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jun GUO, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun GUO, MD

CONTACT

086-10-88121122; guoj307@126.com

Chuanliang CUI, MD

CONTACT

0086-10- 88196348; 1008ccl@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: April 11, 2024
• Study Start: November 7, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)