- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07559929
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.
27 maja 2026 zaktualizowane przez: 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).
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
200
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Li Zhang, Doctoral degree
- Numer telefonu: +86-020-87343565
- E-mail: zhangli@sysucc.org.cn
Lokalizacje studiów
-
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Guangdong
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Guangzhou, Guangdong, Chiny, 510060
- Sun Yat-sen University Cancer Center
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Kontakt:
- Li Zhang, Doctoral degree
- Numer telefonu: +86-020-87343565
- E-mail: zhangli@sysucc.org.cn
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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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Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Progression Free Survival (PFS)
Ramy czasowe: 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.
|
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6-month progression-free survival rate
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Maximum observed serum or plasma concentration (Cmax)
Ramy czasowe: Through study completion an average of 1 year.
|
Through study completion an average of 1 year.
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Maximum serum drug time(Tmax)
Ramy czasowe: Through study completion an average of 1 year.
|
Through study completion an average of 1 year.
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Apparent volume of distribution(Vd)
Ramy czasowe: 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)
Ramy czasowe: Through study completion an average of 1 year.
|
Through study completion an average of 1 year.
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Terminal phase elimination half life (t½)
Ramy czasowe: 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).
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Through study completion an average of 1 year.
|
Through study completion an average of 1 year.
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Anti-drug antibodies (ADA)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 czerwca 2026
Zakończenie podstawowe (Szacowany)
1 czerwca 2028
Ukończenie studiów (Szacowany)
30 grudnia 2030
Daty rejestracji na studia
Pierwszy przesłany
24 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 kwietnia 2026
Pierwszy wysłany (Rzeczywisty)
30 kwietnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
29 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 maja 2026
Ostatnia weryfikacja
1 marca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby Układu Oddechowego
- Choroby płuc
- Nowotwory Układu Oddechowego
- Nowotwory klatki piersiowej
- Nowotwory płuc
- Rak, Bronchogenny
- Nowotwory oskrzeli
- Rak Drobnokomórkowy Płuc
- Organiczne chemikalia
- Chemikalia nieorganiczne
- Związki chloru
- Związki azotu
- Kompleksy koordynacyjne
- Związki platynowe
- Karboplatyna
- Cisplatyna
- Toripalimab
Inne numery identyfikacyjne badania
- DXC006-002
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .