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

30. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

264

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 navne:
  • SYS6006 injection
Biologisk: Enlonstobart
Enlonstobart IV
Andre navne:
  • Enlonstobart injection
Aktiv komparator: Enlonstobart
Phase II Investigational Treatment:Enlonstobart Intravenous infusion
Biologisk: Enlonstobart
Enlonstobart IV
Andre navne:
  • Enlonstobart injection

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

29. maj 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. januar 2030

Datoer for studieregistrering

Først indsendt

17. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SYS6006-009

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Kliniske forsøg med Avancerede solide tumorer

Kliniske forsøg med SYS6006

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