- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07559929
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.
27. května 2026 aktualizováno: 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).
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
200
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Li Zhang, Doctoral degree
- Telefonní číslo: +86-020-87343565
- E-mail: zhangli@sysucc.org.cn
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510060
- Sun Yat-sen University Cancer Center
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Kontakt:
- Li Zhang, Doctoral degree
- Telefonní číslo: +86-020-87343565
- E-mail: zhangli@sysucc.org.cn
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Voluntarily signed informed consent and willingness to comply with the protocol requirements.
- Male or female.
- Age ≥18 years and ≤75 years.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Histologically or cytologically confirmed small cell lung cancer (SCLC).
- 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.
- Adequate hepatic, renal, coagulation, and cardiac function.
- 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:
- Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.
- 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).
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.
- Prior treatment with CD56-targeted therapy.
- Symptomatic brain metastases or leptomeningeal metastases.
- History of severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation of immuno-oncology therapy due to intolerance).
- Active autoimmune disease or immunodeficiency, or a history of such conditions.
- Evidence of significant cardiovascular risk.
- 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).
- 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.
- 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.
- History of hypersensitivity to any component or excipient of DXC006, immune checkpoint inhibitors, or platinum-based chemotherapy.
- 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).
- 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).
- 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.
- 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.
- Positive serum pregnancy test or currently breastfeeding female participants.
- Active infection requiring medical therapy (CTCAE Grade ≥2); uncontrollable pleural effusion, ascites, or pericardial effusion requiring repeated drainage.
- Administration of live attenuated vaccines within 28 days prior to the first dose.
- Other conditions that, in the judgment of the investigator, may affect the patient's participation in the study.
- 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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: DXC006 + ICI
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Participants receive DXC006 intravenously on Day 1 every 3 weeks.
Participants receive Toripalimab intravenously on Day 1 every 3 weeks.
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Experimentální: DXC006 + Platinum(Carboplatin )
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Participants receive DXC006 intravenously on Day 1 every 3 weeks.
Participants receive Carboplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).
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Experimentální: DXC006 + Platinum(Cisplatin )
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Participants receive DXC006 intravenously on Day 1 every 3 weeks.
Participants receive Cisplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Progression Free Survival (PFS)
Časové okno: 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.
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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.
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6-month progression-free survival rate
Časové okno: 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.
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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.
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Recommended Phase 2 Dose (RP2D)
Časové okno: Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
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Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
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Measurement of objective response rate (ORR) per RECIST 1.1
Časové okno: 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.
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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.
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Measurement of disease control rate (DCR)
Časové okno: 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.
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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.
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Incidence of Adverse Events (AEs)
Časové okno: After first infusion of study drug, through study completion an average of 2 year.
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After first infusion of study drug, through study completion an average of 2 year.
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Maximum observed serum or plasma concentration (Cmax)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Maximum serum drug time(Tmax)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Apparent volume of distribution(Vd)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Volume of distribution at steady state (Vss)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Terminal phase elimination half life (t½)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t).
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Clearance (CL)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Ctrough
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Anti-drug antibodies (ADA)
Časové okno: Through study completion an average of 1 year.
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Through study completion an average of 1 year.
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Overall Survival (OS)
Časové okno: 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.
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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.
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Duration of response (DOR)
Časové okno: 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.
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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.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. června 2028
Dokončení studie (Odhadovaný)
30. prosince 2030
Termíny zápisu do studia
První předloženo
24. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
24. dubna 2026
První zveřejněno (Aktuální)
30. dubna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. května 2026
Naposledy ověřeno
1. března 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Nemoci dýchacích cest
- Plicní onemocnění
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Novotvary plic
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Malobuněčný karcinom plic
- Organické chemikálie
- Anorganické chemikálie
- Sloučeniny chloru
- Sloučeniny dusíku
- Koordinační komplexy
- Platinové sloučeniny
- Karboplatina
- Cisplatina
- Toripalimab
Další identifikační čísla studie
- DXC006-002
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