- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07559929
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.
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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Li Zhang, Doctoral degree
- Telefonnummer: +86-020-87343565
- E-post: zhangli@sysucc.org.cn
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
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Ta kontakt med:
- Li Zhang, Doctoral degree
- Telefonnummer: +86-020-87343565
- E-post: zhangli@sysucc.org.cn
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Progression Free Survival (PFS)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Maximum observed serum or plasma concentration (Cmax)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Småcellet lungekarsinom
- Organiske kjemikalier
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Platinumforbindelser
- Karboplatin
- Cisplatin
- Toripalimab
Andre studie-ID-numre
- DXC006-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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