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

30 maj 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

264

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Andra namn:
  • SYS6006 injection
Biologisk: Enlonstobart
Enlonstobart IV
Andra namn:
  • Enlonstobart injection
Aktiv komparator: Enlonstobart
Phase II Investigational Treatment:Enlonstobart Intravenous infusion
Biologisk: Enlonstobart
Enlonstobart IV
Andra namn:
  • Enlonstobart injection

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase)
Tidsram: 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) .
Tidsram: 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)
Tidsram: Through study completion, an average of l year
Through study completion, an average of l year
Phase Ib:Maximum tolerated dose (MTD)
Tidsram: 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)
Tidsram: 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
Tidsram: through study completion, an average of 1year.
through study completion, an average of 1year.
Phase II: Incidence and frequency of TEAEs.
Tidsram: through study completion, an average of l year
through study completion, an average of l year
Phase II:Incidence and frequency of SAEs.
Tidsram: through study completion, an average of l year
through study completion, an average of l year

Sekundära resultatmått

Resultatmått
Tidsram
Disease control rate (DCR) per RECIST 1.1
Tidsram: 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
Tidsram: 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
Tidsram: Up to approximately 24months after the first participant is enrolled
Up to approximately 24months after the first participant is enrolled
Time to response(TTR)
Tidsram: Up to approximately 24months after the first participant is enrolled
Up to approximately 24months after the first participant is enrolled
Overall survival(OS)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: through study completion, an average of l year
through study completion, an average of l year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

29 maj 2026

Primärt slutförande (Beräknad)

31 december 2028

Avslutad studie (Beräknad)

31 januari 2030

Studieregistreringsdatum

Först inskickad

17 maj 2026

Först inskickad som uppfyllde QC-kriterierna

30 maj 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SYS6006-009

Läkemedels- och apparatinformation, studiedokument

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