Study of ST-1898 in Advanced Renal Cell Carcinoma

NCT06127238 | Active Not Recruiting Phase 1

• 1 other identifier: ST-1898-201
• Study Type: interventional
• Target: 90
• 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 patients with advanced renal cell carcinoma (RCC). In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine the maximum tolerated dose (MTD) of ST-1898 tablets in patients with advanced RCC. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy in patients with advanced RCC. In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in patients with advanced RCC. The secondary objective is to evaluate the safety of ST-1898 tablets in patients with advanced RCC.

Conditions

Advanced Renal Cell Carcinoma

Keywords

ST-1898, renal cell carcinoma

Outcome Measures

Primary Outcomes (3)

• Phase Ib Dose Escalation：Maximum Tolerated Dose (MTD)

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

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

  Approximately 18 months

• 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 (13)

• Phase Ib Dose Escalation: Plasma PK

  On Day 1, 8, 21 of Cycle 1 and Day 1 of Cycle 3, approximately 10 weeks

• Phase Ib Dose Escalation: ORR

  Approximately 18 months

• Phase Ib Dose Escalation: DOR

  Approximately 18 months

• Phase Ib Dose Escalation: PFS

  Approximately 18 months

• Phase Ib Dose Escalation: DCR

  Approximately 18 months

Study Arms (2)

ST-1898 Phase Ib

EXPERIMENTAL

Dose Escalation:participants will be administered orally at 100mg,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: participants with advanced renal cell carcinoma will be dministered 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 and medical imaging confirmed unresectable, locally advanced or metastatic renal cell carcinoma. In Dose Escalation Phase, subjects should be progressed with standard therapy, not eligible for standard therapy or no standard therapy available；in Dose Expansion Phase, subjects should be progressed with prior immune checkpoint inhibitor and tyrosine kinase inhibitor therapy.
• With agreement to provide a tumor tissue specimen
• Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol
• Has at least one measurable lesion as defined by RECIST version 1.1
• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
• Has adequate organ function defined as follows:
• Bone marrow : absolute neutrophil count(ANC)≥1.5×10\^9 /L, Hb level ≥ 90 g/L and platelet count (PLT) ≥ 90 x10\^9/L, no transfusions and no use of colony stimulating factor within 2 weeks prior to routine blood test) at screening;
• Liver: transaminase levels (AST/ALT) ≤ 3.0×upper limit of normal (ULN), AST/ALT ≤ 5×ULN for liver metastasis; total bilirubin (TBILI) ≤ 1.5 ×ULN;
• Kidney: Creatinine ≤1.5×ULN
• Heart: LVEF≥50%
• Coagulation function: INR≤1.5×ULN，APTT≤1.5×ULN (except for the prophylactic use of anticoagulants)
• Urine protein ≤1+; or in the condition of urine protein ≥2+, quantitative measurement of the 24-hour urine protein is \< 1g
• Women of child bearing potential must have a negative serum pregnancy test within 7 days before first study drug administration. Female patients of child bearing potential, or a male patients with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use a highly effective method of contraception during screening, during the period of drug administration and for 120 days after stopping study drug administration.

You may not qualify if:

• Has received another anti-tumor therapy within two weeks or within 5 half-life of anti- tumor drug prior to the first dose
• Has had major surgery within 4 weeks before the first study drug administration (except tumor biopsy, puncture, invasive dental procedures such as tooth extraction, dental implants etc.)
• Current or previous severe retinopathy who, in the judgment of the Investigator or specialist, are not suitable for enrollment
• Has had any history of major cardiovascular event within 6 months prior to study drug administration including but not limited to :
• Serious arrhythmia or cardiac conduct abnormality , such as degree II-III atrioventricular block or ventricular arrhythmia needs to be treated
• QTc interval extension: male \>450 ms, female \>470 ms
• Acute coronary syndrome, stroke, deep vein thrombosis, pulmonary- thromboembolism, arterial thrombosis, congestive heart failure, aortic dissection etc.
• New York Heart Association Class ≥ II
• Has uncontrolled hypertension, as defined by a sustained blood pressure (BP) \> 140/90 mmHg with antihypertensive treatment
• Has brain metastases with symptoms or with evidence of progression
• Has Interstitial lung disease or radiation pneumonia requiring treatment by steroid
• Has other malignant tumors in the last 5 years (not including non-melanoma skin cancer, breast cancer or cervical cancer in situ, and Non-Muscle-invasive bladder cancer that have been cured)
• Has ≥ grade 3 hemorrhage/bleeding event within 6 months prior to study drug administration or currently ≥ grade 2 hemorrhage or event of high risk of hemorrhage) including active gastrointestinal ulcer or esophageal varices
• Concomitant medication with strong inducers of CYP3A4, strong inhibitors of CYP3A4, or CYP3A4 substrates with narrow therapeutic windows within 2 weeks prior to first dose.
• Has not recovered from toxicities caused by prior therapy to CTCAE≤ Grade 1 (except for peripheral neuropathy becoming ≤Grade 2, alopecia, and other events judged tolerable by the Investigator and without safety risks).

Sponsors & Collaborators

• Beijing Scitech-Mq Pharmaceuticals Limited: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

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

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jun Guo, Ph D

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Sequential Assignment Escalation followed by Dose Expansion

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: November 13, 2023
• Study Start: February 7, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)