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Not yet recruiting NCT07622225

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

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SYS6006, Enlonstobart.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Biological SYS6006
    Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection
  • Biological Enlonstobart
    Enlonstobart IV

Primary outcome measures

  • 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]
  • Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) . [Time frame: Through study completion, an average of l year]
  • Phase Ib:Incidence and frequency of serious adverse events (SAEs) [Time frame: Through study completion, an average of l year]
  • Phase Ib:Maximum tolerated dose (MTD) [Time frame: Every 21 days while on treatment (estimated 6 months)]
  • Phase Ib: Recommended Phase II dose (RP2D) [Time frame: Every 21 days while on treatment (estimated 6 months)]
  • Phase II: ORR as assessed by the investigator according to RECIST v1.1 [Time frame: through study completion, an average of 1year.]
  • Phase II: Incidence and frequency of TEAEs. [Time frame: through study completion, an average of l year]
  • Phase II:Incidence and frequency of SAEs. [Time frame: through study completion, an average of l year]
Secondary outcome measures (9)
  • Disease control rate (DCR) per RECIST 1.1 [Time frame: Up to approximately 24 months after the first participant is enrolled]
  • Duration of response (DoR) per RECIST 1.1 [Time frame: Up to approximately 24 months after the first participant is enrolled]
  • Progression free survival (PFS) per RECIST 1.1 [Time frame: Up to approximately 24months after the first participant is enrolled]
  • Time to response(TTR) [Time frame: Up to approximately 24months after the first participant is enrolled]
  • Overall survival(OS) [Time frame: Up to approximately 24 months after the first participant is enrolled]
  • Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0) [Time frame: Up to approximately 24 months after the first participant is enrolled]
  • PK parameters: The plasma concentration of enlonstobart [Time frame: 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) [Time frame: 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 [Time frame: through study completion, an average of l year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07622225 · SYS6006-009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗