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Advanced Renal Cell CarcinomaPhase 1/2NCT06127238

Study of ST-1898 in Advanced Renal Cell Carcinoma

A Phase 1/2 study testing ST-1898 tablets in people with Advanced Renal Cell Carcinoma, 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 patients with advanced renal cell carcinoma (RCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Renal Cell Carcinoma
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
90 participants
Where
1 siteChina
Study dates
7 Feb 2023to Feb 2027
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 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
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  • 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.

Who cannot join

  • 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
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  • 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).
  • Active hepatitis B (asymptomatic hepatitis B carriers with HBV DNA < 2000 IU/mL are allowed to be enrolled), hepatitis C virus (HCV) antibody-positive and HCV-RNA- positive, or other active hepatitis, clinically significant moderate-to-severe cirrhosis, are allowed to receive prophylactic antiviral therapy other than interferon.
  • Has acute bacterial, viral or fungal infections, requiring systemic anti-infective treatment.
  • HIV positive
  • Pregnant or lactating females
  • Drug or alcohol dependents
  • Has significant disorder of neurology or mental disease or poorly compliance
  • Unable to swallow oral medications or condition or conditions that in the judgment of the Investigator which severely interfere with gastrointestinal absorption, such as dysphagia, intestinal obstruction, etc.
  • Clinically uncontrollable third interstitial effusion that, in the judgment of the Investigator, is unsuitable for enrollment.
  • Has a history of other serious systemic disease, or any other reason that might interfere with participation in trial or interfere with interpretation of trial results, in the judgement of the Investigator, that are not qualified to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Phase Ib/II Study of ST-1898 to Evaluate the Efficacy and Safety in Patients With Renal Cell Carcinoma (RCC)

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.

Being tested
ST-1898 tablets
Keywords
ST-1898, renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell

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 NCT06127238
Study groupRoleWhat they receive
ST-1898 Phase IbExperimentalDose Escalation:participants will be administered orally at 100mg,140mg,160mg,180mg, 220mg,QD during the study, until disease progression or intolerable toxicity.
Receives: Drug: ST-1898 tablets
ST-1898 Phase IIExperimentalDose 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.
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：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.

    Measured: Within the first cycle (21days)

  2. 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.

    Measured: Approximately 18 months

  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 (13)

  1. Phase Ib Dose Escalation: Plasma PK

    To assess plasma pharmacokinetics (PK) of oral administration of ST-1898 in participants with advanced renal cell carcinoma

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

  2. Phase Ib Dose Escalation: ORR

    Objective Response Rate (ORR) per RECIST 1.1

    Measured: Approximately 18 months

  3. Phase Ib Dose Escalation: DOR

    DOR Duration of Response (DOR) 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: DCR

    Disease Control Rate (DCR) per RECIST 1.1

    Measured: Approximately 18 months

  6. Phase Ib Dose Escalation: OS

    Overall Survival (OS)

    Measured: Approximately 30 months

  7. Phase Ib Dose Escalation: TTP

    Time to Progression（TTP）per RECIST 1.1

    Measured: Approximately 18 months

  8. Phase II Dose Expansion: DOR

    DOR Duration of Response (DOR) per RECIST 1.1

    Measured: Approximately 18 months

  9. Phase II Dose Expansion: PFS

    Progression-Free Survival (PFS) per RECIST 1.1

    Measured: Approximately 18 months

  10. Phase II Dose Expansion: DCR

    Disease Control Rate (DCR) per RECIST 1.1

    Measured: Approximately 18 months

  11. Phase II Dose Expansion: OS

    Overall Survival (OS) per RECIST 1.1

    Measured: Approximately 30 months

  12. Phase II Dose Expansion: OS12m

    12-Month survival rate（OS12m）

    Measured: 12 months

  13. 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

Timeline

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

  1. First posted13 Nov 2023
  2. Study start7 Feb 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (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
Model description
Sequential Assignment Escalation followed by Dose Expansion
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127238
Sponsor's protocol ID
ST-1898-201
Status last verified
Oct 2026
First submitted
22 Oct 2023
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 Advanced Renal Cell Carcinoma, 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 15 inclusion and 24 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：Maximum Tolerated Dose (MTD) (time frame: Within the first cycle (21days)). 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 NCT06127238.

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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