Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI

NCT05869162 | Unknown Phase 2

• 1 other identifier: CT-3505-II-01
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, multicenter, phase II study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK tyrosine kinase inhibitor (TKI).

Conditions

Non-small-cell Lung Carcinoma

Keywords

SY-3505; Anaplastic lymphoma kinase; Non-small cell lung carcinoma; Third-generation ALK tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) assessed by the independent review committee (IRC)

  ORR is defined as the proportion of patients achieving an objective response (complete response \[CR\] or partial response \[PR\]) according to Response Evaluation Criteria in Solid Tumors (RECIST), v.1.1 (RECIST 1.1).

  Up to 2 years

Secondary Outcomes (10)

• ORR assessed by the investigator

  Up to 2 years

• Disease Control Rate (DCR) assessed by the investigator and IRC

  Up to 2 years

• Progression-Free Survival (PFS) assessed by the investigator and IRC

  Up to 2 years

• Time to Tumor Response (TTR) assessed by the investigator and IRC

  Up to 2 years

• Duration of Response (DoR) assessed by the investigator and IRC

  Up to 2 years

Study Arms (1)

SY-3505-Phase II

EXPERIMENTAL

SY-3505 single agent, 600 mg oral capsules, QD, continuously

Drug: SY-3505

Interventions

SY-3505 DRUG

A Third-generation ALK TKI

Also known as: CT-3505

SY-3505-Phase II

Eligibility Criteria

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

You may qualify if:

• Patients must meet all of the following criteria to be eligible to participate in this study:
• Age ≥ 18 years at the time of signing the informed consent form (ICF).
• Histologically or cytologically confirmed locally advanced (tumor lesion could not be radically cued by surgery or radiation as asessed by the investigators) or metastatic NSCLC.
• Prior treated with at least one second-generation ALK TKI (including unmarketed investigational drugs) and imaging evidence of disease progression (PD) or intolerance to prior treatment toxicity.
• Agree to provide fresh tumor tissue samples to test positive for ALK fusion (ALK-positive) by the central laboratory:
• Must have at least one extracranial target lesion that meets the RECIST 1.1 criteria; For a lesion that has previously received radiotherapy, it can be assessed as a target lesion only when it shows definite progression after radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Estimated Life expectancy ≥ 3 months.
• Prior antitumor treatment-related AE had recovered to ≤ Grade 1 as defined by NCI-CTCAE v 5.0 prior to initial administration (except for toxicities without safety risk as determined by the investigator, such as alopecia, Grade 2 peripheral neurotoxicity associated with prior platinum therapy, etc.).
• Organ function shall meet the following requirements:
• No blood products, hematopoietic cell growth factors (e.g., granulocyte colony stimulating factor, erythropoietin), or other medication received to correct abnormal blood routine at least 2 weeks before initial administration, and blood routine: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets (PLT) ≥100×109/L, Platelets (Hb) ≥90g/L;
• Pancreatic function: Serum total amylase ≤1.5× upper limit of normal (ULN); Serum lipase ≤1.5×ULN (it is allowed to be included if serum total amylase\>1.5× ULN, but the pancreatic amylase is in the ULN range);
• Hepatic function: Total serum bilirubin (TBIL) ≤ 1.5×ULN, Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5×ULN if no liver metastases, or otherwise TBIL ≤ 3×ULN, AST and ALT ≤ 5×ULN.
• Renal function: Creatinine clearance ≥ 50 mL/min (according to Cockcroft-Gault Equation).
• Coagulation function: International normalized ratio (INR) and prothrombin time (PT)≤ 1.5×ULN (except for patients receiving anticoagulant therapy).

You may not qualify if:

• Patients who meet any of the following criteria are not eligible to participate in this study:
• Patients with known driver alterations other than ALK, such as EGFR, MET, RET, ROS1, NTRK, etc. (If ALK co-mutation exists, the patient can discuss with the investigator for enrollment);
• Previous treated with any third-generation ALK TKI (including marketed drugs such as loratinib, and unmarketed investigational drugs);
• History of allergy to any component or excipient of SY-3505 capsules;
• With other primary malignancies, except those that have been cured and have not recurred within 2 years prior to screening, and those that have been cured of basal or squamous cell carcinoma of the skin, carcinoma in situ of cervix, or carcinoma in situ of breast;
• The presence of symptomatic primary CNS tumors, symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Except: Patient had stable CNS disease (no evidence of progression identified by imaging for at least 4 weeks prior to initial administration, and all neurological symptoms had recovered to baseline), no evidence of new or progressive brain metastases, no CNS surgery or radiotherapy within 4 weeks prior to initial administration, and no stereotactic radiosurgery (SRS) within 2 weeks prior to initial administration. Steroid administration was stopped or the dose stabilized within 2 weeks prior to initial administration. (This exception does not include cancerous meningitis, which should be excluded regardless of clinically stable conditions).
• The following symptoms or diseases occurred prior to initial administration and remain poorly controlled after optimal treatment:
• Systemic bacterial, viral or fungal infection with uncontrolled activity;
• Poorly controlled (poorly control refers to the effusion increases significantly within 2 weeks after extraction, with obvious symptoms, requiring further puncture or other intervention) pleural effusion, abdominal effusion or pericardial effusion after intervention (such as drainage) ;
• Poorly controlled diabetes (fasting blood glucose ≥11.1 mmol/L and/or HbA1c ≥ 8%);
• Uncontrolled symptomatic hyperthyroidism or hypothyroidism as assessed by the investigator;
• Uncontrolled electrolyte disturbances (e.g., hypocalcemia, hypomagnesium, hypokalemia) as assessed by the investigator;
• Clinically significant gastrointestinal disorders included active ulcerative colitis, Crohn's disease, gastrointestinal ulcers, or prior surgical procedures that could significantly affect drug absorption as assessed by the investigator.
• Presence with severe cardiovascular diseases/abnormalities, meeting any of the following criteria:
• Patients with corrected QT interval for heart rate according to Fridericia's formula \> 470 msec (females) and \> 450 msec (males) during the screening period (If prolonged QTcF suspected to be caused by medication and was assessed as safe and controllable by the investigator, the patient can be enrolled after drug correction);

Sponsors & Collaborators

• Shouyao Holdings (Beijing) Co. LTD: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yinghui Sun

  Shouyao Holdings (Beijing) Co. LTD

  STUDY DIRECTOR

Central Study Contacts

Yinghui Sun

CONTACT

86-10-88858616; yhsun@centaurusbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: June 30, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-05

Locations

CN (1)