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SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

30. mai 2026 oppdatert av: CSPC Megalith Biopharmaceutical Co.,Ltd.

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

This study is a Phase Ib/II clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

264

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Clinical Trials Information Group Officer
  • Telefonnummer: 86-0311-69085587
  • E-post: ctr-contact@cspc.cn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 1. Able to understand and voluntarily sign the written informed consent form (ICF);
  • 2. Male or female subjects aged over 18 years old (inclusive).
  • 3. Patients with solid tumor who have unresectable locally advanced or metastatic disease;
  • 4. At least one measurable lesion, as defined by RECIST 1.1 criteria;
  • 5. ECOG performance status of 0-2;
  • 6. Expected survival ≥ 3 months;
  • 7. Adequate function of major organs and bone marrow;
  • 8. Women or man of childbearing potential must use highly effective contraception.

Exclusion Criteria:

  • 1. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
  • 2. Patients with a history of autoimmune diseases;
  • 3. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
  • 4. Severe or uncontrolled cardiovascular disorder requiring treatment;
  • 5. Women who are pregnant or breastfeeding.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SYS6006 + Enlonstobart

Phase Ib Dose Escalation Cohort Dose level 1 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart.

Dose level 2 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart.

  1. If 0/3 participants experience a DLT, the next 3 participants can be enrolled to receive the same dose regimen, and escalation to the next dose group may proceed;

  2. If 1/3 participants experience a DLT, an additional 3 participants will be enrolled to continue evaluation at the same dose regimen:

    If a final total of 1/6 participants experience a DLT, escalation to the next dose group may proceed; If ≥2 of the 6 evaluable participants experience a DLT, escalation will be stopped;

  3. If ≥2/3 participants experience a DLT, escalation will be stopped.

Phase II Investigational Treatment:The maximum safe dose of SYS6006 in combination Enlonstobart (as determined in the phase Ib cohort).
Biologisk: SYS6006
Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection
Andre navn:
  • SYS6006 injection
Biologisk: Enlonstobart
Enlonstobart IV
Andre navn:
  • Enlonstobart injection
Aktiv komparator: Enlonstobart
Phase II Investigational Treatment:Enlonstobart Intravenous infusion
Biologisk: Enlonstobart
Enlonstobart IV
Andre navn:
  • Enlonstobart injection

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase)
Tidsramme: Within 21 days after the start of the treatment
Within 21 days after the start of the treatment
Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) .
Tidsramme: Through study completion, an average of l year
Through study completion, an average of l year
Phase Ib:Incidence and frequency of serious adverse events (SAEs)
Tidsramme: Through study completion, an average of l year
Through study completion, an average of l year
Phase Ib:Maximum tolerated dose (MTD)
Tidsramme: Every 21 days while on treatment (estimated 6 months)
Every 21 days while on treatment (estimated 6 months)
Phase Ib: Recommended Phase II dose (RP2D)
Tidsramme: Every 21 days while on treatment (estimated 6 months)
Every 21 days while on treatment (estimated 6 months)
Phase II: ORR as assessed by the investigator according to RECIST v1.1
Tidsramme: through study completion, an average of 1year.
through study completion, an average of 1year.
Phase II: Incidence and frequency of TEAEs.
Tidsramme: through study completion, an average of l year
through study completion, an average of l year
Phase II:Incidence and frequency of SAEs.
Tidsramme: through study completion, an average of l year
through study completion, an average of l year

Sekundære resultatmål

Resultatmål
Tidsramme
Disease control rate (DCR) per RECIST 1.1
Tidsramme: Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
Tidsramme: Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
Tidsramme: Up to approximately 24months after the first participant is enrolled
Up to approximately 24months after the first participant is enrolled
Time to response(TTR)
Tidsramme: Up to approximately 24months after the first participant is enrolled
Up to approximately 24months after the first participant is enrolled
Overall survival(OS)
Tidsramme: Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0)
Tidsramme: Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
PK parameters: The plasma concentration of enlonstobart
Tidsramme: Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
Correlation between PD-L1 expression level (measured as Tumor Proportion Score [TPS] by 22C3 IHC assay) and objective response rate (ORR, as assessed by RECIST 1.1 criteria)
Tidsramme: Up to approximately 24 months after the first participant is enrolled
Up to approximately 24 months after the first participant is enrolled
To evaluate changes in cytokines such as interferon-alpha (IFNα) and the activation status of peripheral blood immune cells
Tidsramme: through study completion, an average of l year
through study completion, an average of l year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

29. mai 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. januar 2030

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

30. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SYS6006-009

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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