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A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC (SYS6010)

2 luglio 2026 aggiornato da: Yongsheng Wang, Sichuan University

Introduction: Patients with driver gene-negative non-small cell lung cancer (NSCLC) who experience treatment failure following immune checkpoint inhibitor (ICI) therapy have limited subsequent treatment options, representing an unmet clinical need. EGFR is commonly expressed in EGFR wild-type NSCLC and represents a potential target for therapeutic intervention. Antibody-drug conjugates (ADCs) combine the high targeting specificity of antibodies with the potent cytotoxic effects of payloads. SYS6010 is an EGFR-targeting ADC conjugated to a topoisomerase I inhibitor. Preclinical and clinical studies suggest that the combination of ADCs and ICIs can synergistically enhance anti-tumor efficacy through multiple immunomodulatory mechanisms. Tislelizumab is an approved PD-1 inhibitor for advanced NSCLC. This study aims to evaluate the safety and efficacy of SYS6010 in combination with tislelizumab in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.

Methods: This is an exploratory clinical trial enrolling patients with driver gene-negative NSCLC who have failed prior PD-1 or PD-L1 inhibitor therapy. The primary objective is to evaluate the safety of the combination therapy, with primary endpoints including the incidence, severity, and type of adverse events (AEs) according to NCI-CTCAE v6.0 criteria. Secondary objectives include assessing efficacy (objective response rate [ORR], disease control rate [DCR], duration of response [DOR], progression-free survival [PFS], overall survival [OS]) and exploring the association of potential predictive or prognostic biomarkers (e.g., EGFR and PD-L1 expression levels) with response to study treatment.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

21

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Please Select
      • Chengdu, Please Select, Cina, 610041
        • West China Hospital, Sichuan University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:

Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.

Have no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.

Have experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:

Progression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or

Progression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or

Progression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or

Progression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).

a. Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.

Have at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).

Have a life expectancy of ≥ 3 months as assessed by the investigator.

Agree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.

Have adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):

Bone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; haemoglobin ≥ 90 g/L.

Hepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g/L.

Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 3).

Coagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

Subjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA < 1000 IU/mL and be willing to receive antiviral therapy throughout the study period.

Toxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).

Subjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).

Subjects must be able to communicate well with the investigator and comply with protocol-required follow-up.

Exclusion Criteria:

  • Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:

Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.

Have no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.

Have experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:

Progression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or

Progression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or

Progression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or

Progression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).

a. Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.

Have at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).

Have a life expectancy of ≥ 3 months as assessed by the investigator.

Agree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.

Have adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):

Bone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; haemoglobin ≥ 90 g/L.

Hepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g/L.

Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 3).

Coagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

Subjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA < 1000 IU/mL and be willing to receive antiviral therapy throughout the study period.

Toxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).

Subjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).

Subjects must be able to communicate well with the investigator and comply with protocol-required follow-up.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Tislelizumab plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC
Droga: SYS6010
SYS6010 4.2mg/kg,Ivgtt，Q3W，plus Tislelizumab，200 mg，Ivgtt，Q3W

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
incidence of adverse effect
Lasso di tempo: From date of first administration up to approximately 3.5 years after the last patient is administrated
From date of first administration up to approximately 3.5 years after the last patient is administrated

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tasso di risposta obiettivo （ORR）
Lasso di tempo: Circa 9-11 settimane dopo la prima dose
ORR è la proporzione di soggetti con CR o PR, in base a RECIST V1.1.
Circa 9-11 settimane dopo la prima dose
Sopravvivenza globale (sistema operativo)
Lasso di tempo: Dalla data di prima somministrazione fino a circa 5,5 anni dopo la somministrazione dell'ultimo paziente
Il sistema operativo sarà definito come il tempo dalla data del primo dosaggio fino alla morte a causa di qualsiasi causa
Dalla data di prima somministrazione fino a circa 5,5 anni dopo la somministrazione dell'ultimo paziente
Disease Control Rate（DCR）
Lasso di tempo: From date of first administration up to approximately 3.5 years after the last patient is administrated
It represents the total proportion of patients who achieved complete response (CR), partial response (PR), and disease stability (SD) after treatment, reflecting the overall control ability of the treatment on tumor growth.
From date of first administration up to approximately 3.5 years after the last patient is administrated
Duration of Response(DOR)
Lasso di tempo: From date of first administration up to approximately 3.5 years after the last patient is administrated
It refers to the period from when a patient starts receiving treatment until the tumor lesion shows an objective response (such as shrinking or disappearing) and then the disease progresses or recurs again.
From date of first administration up to approximately 3.5 years after the last patient is administrated
Progression-Free Survival(PFS)
Lasso di tempo: From date of first administration up to approximately 3.5 years after the last patient is administrated
Its definition is: the period from the start of randomization until tumor progression occurs objectively or until death due to any reason.
From date of first administration up to approximately 3.5 years after the last patient is administrated

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
EGFR protein expression
Lasso di tempo: From date of first administration up to approximately 5.5 years after the last patient is administrated
The correlation between EGFR protein expression and amplification level and the efficacy of ADC
From date of first administration up to approximately 5.5 years after the last patient is administrated
PD-L1 protein expression
Lasso di tempo: From date of first administration up to approximately 5.5 years after the last patient is administrated
The correlation between PD-L1 protein expression and the efficacy of combined treatment, etc.
From date of first administration up to approximately 5.5 years after the last patient is administrated

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sichuan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SYS6010-2025-11-17-YSW

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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