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

27 de mayo de 2026 actualizado por: 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).

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Li Zhang, Doctoral degree
  • Número de teléfono: +86-020-87343565
  • Correo electrónico: zhangli@sysucc.org.cn

Ubicaciones de estudio

    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510060
        • Sun Yat-sen University Cancer Center
        • Contacto:
          • Li Zhang, Doctoral degree
          • Número de teléfono: +86-020-87343565
          • Correo electrónico: zhangli@sysucc.org.cn

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: DXC006 + ICI
Participants receive DXC006 intravenously on Day 1 every 3 weeks.
Participants receive Toripalimab intravenously on Day 1 every 3 weeks.
Experimental: 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).
Experimental: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Progression Free Survival (PFS)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Maximum observed serum or plasma concentration (Cmax)
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Maximum serum drug time(Tmax)
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Apparent volume of distribution(Vd)
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Volume of distribution at steady state (Vss)
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Terminal phase elimination half life (t½)
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Clearance (CL)
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Ctrough
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Anti-drug antibodies (ADA)
Periodo de tiempo: Through study completion an average of 1 year.
Through study completion an average of 1 year.
Overall Survival (OS)
Periodo de tiempo: 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)
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

30 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de mayo de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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