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Advanced Solid TumorPhase 1NCT06037317

A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors

A Phase 1 study testing SY-3505 in people with Advanced Solid Tumor, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK fusion-positive solid tumor who have progressed on or are intolerant to prior standard therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SY-3505
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
30 May 2024to 30 May 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Patients must meet all of the following criteria to be eligible for this study:
  • Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).
  • Histologically or cytologically confirmed locally advanced (as assessed by the investigator, unresectable tumor or tumor recurrence following standard therapy with evidence of progression [PD] or intolerance to prior therapy) or metastatic solid tumor and failure of standard treatment with evidence of disease progression on imaging.
  • Agreement to provide a required tumor tissue sample (preferably fresh biopsy tissue or archived tumor tissue within 2 years prior to first dosing) that has been tested by the central laboratory and determined to be positive for LTK gene fusion.
  • At least one measurable extracranial lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
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  • Expected survival of ≥ 3 months.
  • Resolution of any treatment-related AEs related to prior anticancer therapy to NCI-CTCAE v 5.0 grade ≤ 1 (excluding toxicities judged by the investigator to be of no safety concern, e.g., hair loss, prior platinum-related grade 2 peripheral neuropathy) before the first dosing.
  • Organ function levels must meet the following requirements:
  • No blood products, hematopoietic growth factors (e.g., G-CSF, erythropoietin), or other drugs that correct abnormal blood counts for at least 2 weeks before first dosing and the following blood counts: ANC ≥ 1.5 × 10^9/L, PLT count ≥ 100 × 10^9/L, Hb ≥ 90 g/L.
  • Liver function: TBIL ≤ 1.5 × upper limit of normal (ULN) in the absence of liver metastases, and AST and ALT ≤ 2.5 × ULN; in the presence of liver metastases, AST and ALT ≤ 5.0 × ULN, and TBIL ≤ 3 × ULN.
  • Pancreatic function: Serum total amylase ≤ 1.5 × ULN and serum lipase ≤ 1.5 × ULN (subjects with serum total amylase > 1.5 × ULN but with serum lipase within the ULN range may be eligible).
  • Renal function: Creatinine clearance (Ccr) ≥ 50 mL/min (calculated using the Cockcroft and Gault formula).
  • Coagulation function: International normalized ratio (INR) and prothrombin time (PT) ≤ 2 × ULN (except for patients receiving anticoagulant therapy).
  • Able to take oral medications and comply with scheduled visits and related procedures per protocol.
  • Female subjects of childbearing potential must agree to use highly effective contraception during the entire study period and for at least 3 months after the last dose

Who cannot join

  • Patients who meet any of the following criteria are not eligible for this study:
  • Carrying known major driver gene mutations other than LTK gene, such as EGFR, MET, ALK, ROS1, NTRK, etc. (Patients with co-mutations may be discussed with the investigator for eligibility).
  • History of hypersensitivity reactions to any component or excipient of SY-3505 capsules.
  • Concurrent primary malignancy, with the following exceptions: adequately treated in situ carcinoma, non-melanoma skin cancer, in situ cervical cancer, or in situ breast cancer, and cured malignancies without recurrence for at least 2 years prior to study entry.
  • Symptomatic primary central nervous system (CNS) tumors, symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Patients with stable CNS disease (defined as no evidence of progression on imaging for at least 4 weeks prior to first dosing, with all neurological symptoms returned to baseline, and without evidence of new or enlarging brain metastases, and no CNS surgery or radiation treatment within 4 weeks prior to first dosing, and no stereotactic radiosurgery [SRS] within 2 weeks prior to first dosing, and no steroids for at least 2 weeks) are eligible. (Note: Carcinomatous meningitis is not allowed, regardless of clinical stability).
  • Presence of any of the following conditions or diseases at screening that are inadequately controlled with the best possible medical management:
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  • Active systemic bacterial, viral, or fungal infections.
  • Pleural effusion, peritoneal effusion, or pericardial effusion that is not controlled after intervention (defined as significant if reaccumulation of fluid requiring drainage occurs within 2 weeks of the prior intervention with associated symptoms).
  • Poorly controlled diabetes mellitus (defined as fasting blood glucose ≥ 11.1 mmol/L and/or HbA1c ≥ 8%).
  • Symptomatic hyperthyroidism or hypothyroidism not well controlled by medical management as assessed by the investigator.
  • Clinically significant electrolyte disturbances (e.g., severe hypocalcemia, hypomagnesemia, hypokalemia) as assessed by the investigator.
  • Clinically significant gastrointestinal diseases that may interfere with the absorption of study drug (e.g., active ulcerative colitis, Crohn's disease, gastrointestinal ulcers, or major gastrointestinal surgery that might affect drug absorption).
  • Severe cardiovascular diseases/abnormalities meeting any of the following criteria:
  • QT interval corrected for heart rate (QTcF) > 470 msec for females or > 450 msec for males as calculated by the Fridericia formula during screening (subjects with suspected drug-induced QTcF prolongation that is assessed by the investigator as safely controllable may be eligible after correction with medication).
  • Left ventricular ejection fraction (LVEF) < 50%.
  • Myocardial infarction, unstable angina, or clinically significant arrhythmias (e.g., grade 2 second-degree heart block or third-degree heart block) within 6 months prior to the first dosing.
  • Class III or IV congestive heart failure as classified by the New York Heart Association (NYHA).
  • Poorly controlled hypertension, a history of unstable hypertension, or a history of poor compliance with antihypertensive treatment as assessed by the investigator.
  • Active viral infections or a history of the following:
  • Active hepatitis B (HBV) infection (defined as HBsAg positive and HBV DNA ≥ 2 × 10^3 IU/mL at screening, unless HBV DNA levels have decreased to < 2 × 10^3 IU/mL after regular antiviral therapy, in which case the patient may be eligible), or active hepatitis C (HCV) infection (HCV RNA > central laboratory ULN) at screening.
  • HIV positivity at screening or known other immunodeficiency disease.
  • Previous organ transplantation, hematopoietic stem cell transplantation, or bone marrow transplantation.
  • Other significant systemic diseases, including but not limited to active pulmonary disease (e.g., active tuberculosis, interstitial lung disease), that, in the investigator's judgment, may affect the interpretation of study results or pose high risks to the patient.
  • Use of strong CYP3A4 inhibitors or inducers within 2 weeks before the first dosing or during the study period, as follows:
  • CYP3A4 Inhibitors: Azanavir, Clarithromycin, Erdafitinib, Itraconazole, Ketoconazole, Nafitamone, Letermovir, Saquinavir, Telithromycin, Vinorelbine, Grapefruit (juice).
  • CYP3A4 Inducers: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampicin, St. John's Wort, Rifapentine.
  • Receipt of any of the following anticancer treatments:
  • Bone marrow radiation or extensive radiotherapy involving more than 30% of the bone marrow: within 4 weeks before first dosing.
  • Palliative radiotherapy: within 7 days before first dosing.
  • Other anticancer treatments such as chemotherapy, targeted therapy (immunotherapy or other antibody therapy), antitumor Chinese medicine, or others: within 2 weeks before first dosing or within 5 half-lives of the treatment (whichever is longer).
  • Major surgery within 4 weeks before first dosing (major surgery defined as a surgery grade ≥ 3, excluding placement of a central venous catheter, tumor puncture biopsy, and gastrostomy tube placement) or significant traumatic injury that has not fully recovered.
  • Participation in other clinical studies within 4 weeks before first dosing (except for those that do not use investigational drugs or investigational medical devices; subjects who have discontinued treatment from other clinical studies and are only undergoing follow-up are excluded).
  • Severe thromboembolic events within 1 year before the first dosing (e.g., cerebrovascular accidents [including transient ischemic attacks], deep vein thrombosis, pulmonary embolism) or a bleeding tendency/risks within 30 days before the first dosing (e.g., significant gastrointestinal bleeding).
  • Pregnant or lactating women.
  • Other circumstances, as determined by the investigator, which make the patient unsuitable for participation in this clinical trial, such as other serious acute or chronic diseases that may increase the patient's related risks in the study or laboratory abnormalities that may interfere with the interpretation of study results.

Trial locations and contacts

1 site in 1 country.

Yinghui Sun, PhD contact

86-10-88858616

yhsun@centaurusbio.com

China1 site, 1 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

    Yuankai Shi, MD, 86-10-87788293, syuankai@cicams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib, Multi-center, Open-Lable, Dose-Escalation and Dose-Expansion Study of Efficacy and Safety of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors

This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK fusion-positive solid tumor who have progressed on or are intolerant to prior standard therapy.

Read the detailed description

The study will be conducted in 2 parts:

Dose-escalation phase: Participants will be allocated to one of the three dose groups of 500mg, 600mg, or 800mg and receive a single dose of SY-3505 capsules, followed by a 7-day safety observation period and pharmacokinetic (PK) assessment. Subsequently, SY-3505 will be administered once daily in 28-day treatment cycles. This phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and characterize the safety, tolerability and PK of SY-3505 in patients with LTK fusion-positive solid tumors.

Dose-expansion phase: Participants will be assigned to one of the 1-2 dose groups determined during the dose-escalation phase, and receive SY-3505 capsules once daily in 28-day treatment cycles. This phase is designed to evaluate the anti-tumor activity (ORR, DCR and DOR) of SY-3505 in patients with LTK fusion-positive solid tumors.

Being tested
SY-3505
Keywords
SY-3505, Leukocyte receptor tyrosine kinase fusion-positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SY-3505Drug

    Also called CT-3505, Ficonalkib

    LTK tyrosine kinase inhibitor

Study groups in NCT06037317
Study groupRoleWhat they receive
Dose-escalation and Dose-expansionExperimentalIn dose-escalation phase, SY-3505 will be given orally in ascending doses (escalation cohort) until the DLT or RP2D is reached. In dose-expansion phase, SY-3505 will be given at RP2D in 28-day cycle continuously.
Receives: Drug: SY-3505

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Characterization of the safety and tolerability

    Measured: Up to 2 years

  2. Incidence of dose limiting toxicities (DLTs)

    Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) in Cycle 1

    Measured: Escalation Cycle 1 (28 days)

Secondary outcomes (7)

  1. Pharmacokinetics (Cmax) for SY-3505

    Defined as maximum observed plasma concentration

    Measured: Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)

  2. Pharmacokinetics (Tmax) for SY-3505

    Defined as time to maximum plasma concentration

    Measured: Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)

  3. Pharmacokinetics (AUC0-t) for SY-3505

    Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration

    Measured: Protocol-defined time points during Cycle 1 and 2 of treatment (each cycle is 28 days)

  4. Pharmacokinetics (t½) for SY-3505

    Defined as the apparent plasma terminal phase disposition half-life

    Measured: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)

  5. Overall Response Rate (ORR) as assessed by RECIST v1.1

    Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor

    Measured: Up to 2 years

  6. Disease control rate (DCR) as assessed by RECIST v1.1

    Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor

    Measured: Up to 2 years

  7. Duration of response (DOR) as assessed by RECIST v1.1

    Preliminary anti-tumor activity of SY-3505 in patients with LTK-fusion advanced solid tumor

    Measured: Up to 2 years

Timeline

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

  1. First posted14 Sep 2023
  2. Study start30 May 2024 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 May 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06037317
Sponsor's protocol ID
CT-3505-I-03
Status last verified
Jun 2023
First submitted
7 Sep 2023
Last updated
2 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SY-3505 in people with Advanced Solid Tumor, run by Shouyao Holdings (Beijing) Co. LTD 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 16 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yinghui Sun, PhD (86-10-88858616, yhsun@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to 2 years). The study lists 2 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 NCT06037317.

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 2 Feb 2024.

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