Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.

27 maggio 2026 aggiornato da: Hangzhou DAC Biotechnology Co., Ltd.

A Phase Ib/II Study to Evaluate the Safety and Efficacy of DXC006 for Injection Combined With Immune Checkpoint Inhibitors or Platinum-Based Agents in Patients With Small Cell Lung Cancer.

This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Fase 2
  • 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

    • Guangdong
      • Guangzhou, Guangdong, Cina, 510060
        • Sun Yat-sen University Cancer Center
        • 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:

  1. Voluntarily signed informed consent and willingness to comply with the protocol requirements.
  2. Male or female.
  3. Age ≥18 years and ≤75 years.
  4. Life expectancy ≥3 months.
  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  6. Histologically or cytologically confirmed small cell lung cancer (SCLC).
  7. Toxicity from prior anti-tumor therapy has resolved to ≤ Grade 1 as defined by NCI-CTCAE version 6.0 (except alopecia); peripheral neuropathy must have completely resolved.
  8. Adequate hepatic, renal, coagulation, and cardiac function.
  9. The participant and their spouse agree to use effective barrier or pharmacologic contraception (excluding rhythm method) from the time of signing the informed consent until 6 months after the last dose of study treatment.

Exclusion Criteria:

  1. Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.
  2. Within 14 days prior to the first dose: underwent plasmapheresis; received systemic corticosteroid therapy at a daily dose >10 mg prednisone or equivalent (or equivalent anti-inflammatory activity) for more than 3 consecutive days (short-term use for prevention of contrast media allergy is permitted).
  3. Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.
  4. Prior treatment with CD56-targeted therapy.
  5. Symptomatic brain metastases or leptomeningeal metastases.
  6. History of severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation of immuno-oncology therapy due to intolerance).
  7. Active autoimmune disease or immunodeficiency, or a history of such conditions.
  8. Evidence of significant cardiovascular risk.
  9. Dyspnea or current requirement for continuous supplemental oxygen therapy, or current active pneumonitis or interstitial lung disease (except mild cases as determined by the investigator).
  10. History of other primary malignancies, with the exception of malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
  11. Severe non-healing wound, ulcer, or bone fracture; or major surgery within 28 days prior to dosing, or anticipated major surgery during the study period.
  12. History of hypersensitivity to any component or excipient of DXC006, immune checkpoint inhibitors, or platinum-based chemotherapy.
  13. Active hepatitis B (HBV-DNA above the upper limit of normal at the central laboratory or >1000 copies/mL); hepatitis C infection (positive hepatitis C antibody or positive HCV RNA PCR result).
  14. Known positive serology for human immunodeficiency virus (HIV); active syphilis (patients with positive syphilis antibody only are eligible); potential active pulmonary tuberculosis (chest imaging within 3 months prior to the first dose suggestive of active tuberculosis infection).
  15. Active bleeding within 30 days prior to screening, or risk of major gastrointestinal bleeding or hemoptysis as determined by the investigator; or hereditary bleeding tendency, coagulopathy, or bleeding symptoms requiring other medical intervention.
  16. Severe arterial or venous thromboembolic events within 6 months prior to study drug administration, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
  17. Positive serum pregnancy test or currently breastfeeding female participants.
  18. Active infection requiring medical therapy (CTCAE Grade ≥2); uncontrollable pleural effusion, ascites, or pericardial effusion requiring repeated drainage.
  19. Administration of live attenuated vaccines within 28 days prior to the first dose.
  20. Other conditions that, in the judgment of the investigator, may affect the patient's participation in the study.
  21. Poor general condition, such as requirement for mechanical ventilation and/or intravenous catecholamine infusion, and/or severe neurological impairment, coma, and/or quadriplegia with complete loss of communication ability (deafness, blindness, aphasia); uncontrolled seizures; other psychiatric disorders that may affect study participation.

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: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: DXC006 + ICI
Participants receive DXC006 intravenously on Day 1 every 3 weeks.
Participants receive Toripalimab intravenously on Day 1 every 3 weeks.
Sperimentale: DXC006 + Platinum(Carboplatin )
Participants receive DXC006 intravenously on Day 1 every 3 weeks.
Participants receive Carboplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).
Sperimentale: DXC006 + Platinum(Cisplatin )
Participants receive DXC006 intravenously on Day 1 every 3 weeks.
Participants receive Cisplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Progression Free Survival (PFS)
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
6-month progression-free survival rate
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Recommended Phase 2 Dose (RP2D)
Lasso di tempo: Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
Measurement of objective response rate (ORR) per RECIST 1.1
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Measurement of disease control rate (DCR)
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Incidence of Adverse Events (AEs)
Lasso di tempo: After first infusion of study drug, through study completion an average of 2 year.
After first infusion of study drug, through study completion an average of 2 year.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Maximum observed serum or plasma concentration (Cmax)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Maximum serum drug time(Tmax)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Apparent volume of distribution(Vd)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Volume of distribution at steady state (Vss)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Terminal phase elimination half life (t½)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t).
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Clearance (CL)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Ctrough
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Anti-drug antibodies (ADA)
Lasso di tempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Overall Survival (OS)
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Duration of response (DOR)
Lasso di tempo: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.

Collaboratori e investigatori

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

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)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

30 dicembre 2030

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

30 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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 .

Sottoscrivi