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NCT Number: NCT07622225

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SYS6006

Biological

Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection

Other names: SYS6006 injection

Enlonstobart

Biological

Enlonstobart IV

Other names: Enlonstobart injection

Primary outcomes

  1. Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase)

    Time frame: Within 21 days after the start of the treatment

  2. Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) .

    Time frame: Through study completion, an average of l year

  3. Phase Ib:Incidence and frequency of serious adverse events (SAEs)

    Time frame: Through study completion, an average of l year

  4. Phase Ib:Maximum tolerated dose (MTD)

    Time frame: Every 21 days while on treatment (estimated 6 months)

  5. Phase Ib: Recommended Phase II dose (RP2D)

    Time frame: Every 21 days while on treatment (estimated 6 months)

  6. Phase II: ORR as assessed by the investigator according to RECIST v1.1

    Time frame: through study completion, an average of 1year.

  7. Phase II: Incidence and frequency of TEAEs.

    Time frame: through study completion, an average of l year

  8. Phase II:Incidence and frequency of SAEs.

    Time frame: through study completion, an average of l year

Secondary outcomes

  1. Disease control rate (DCR) per RECIST 1.1

    Time frame: Up to approximately 24 months after the first participant is enrolled

  2. Duration of response (DoR) per RECIST 1.1

    Time frame: Up to approximately 24 months after the first participant is enrolled

  3. Progression free survival (PFS) per RECIST 1.1

    Time frame: Up to approximately 24months after the first participant is enrolled

  4. Time to response(TTR)

    Time frame: Up to approximately 24months after the first participant is enrolled

  5. Overall survival(OS)

    Time frame: Up to approximately 24 months after the first participant is enrolled

  6. Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0)

    Time frame: Up to approximately 24 months after the first participant is enrolled

  7. PK parameters: The plasma concentration of enlonstobart

    Time frame: Up to approximately 24 months after the first participant is enrolled

  8. 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)

    Time frame: Up to approximately 24 months after the first participant is enrolled

  9. To evaluate changes in cytokines such as interferon-alpha (IFNα) and the activation status of peripheral blood immune cells

    Time frame: through study completion, an average of l year

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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