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

NCT07622225 | Not Yet Recruiting Phase 1

• 1 other identifier: SYS6006-009
• Study Type: interventional
• Target: 264
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (8)

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

  Within 21 days after the start of the treatment

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

  Through study completion, an average of l year

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

  Through study completion, an average of l year

• Phase Ib:Maximum tolerated dose (MTD)

  Every 21 days while on treatment (estimated 6 months)

• Phase Ib: Recommended Phase II dose (RP2D)

  Every 21 days while on treatment (estimated 6 months)

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

  through study completion, an average of 1year.

• Phase II: Incidence and frequency of TEAEs.

  through study completion, an average of l year

• Phase II:Incidence and frequency of SAEs.

  through study completion, an average of l year

Secondary Outcomes (9)

• Disease control rate (DCR) per RECIST 1.1

  Up to approximately 24 months after the first participant is enrolled

• Duration of response (DoR) per RECIST 1.1

  Up to approximately 24 months after the first participant is enrolled

• Progression free survival (PFS) per RECIST 1.1

  Up to approximately 24months after the first participant is enrolled

• Time to response(TTR)

  Up to approximately 24months after the first participant is enrolled

• Overall survival(OS)

  Up to approximately 24 months after the first participant is enrolled

Study Arms (2)

SYS6006 + Enlonstobart

EXPERIMENTAL

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).

Biological: SYS6006; Biological: Enlonstobart

Enlonstobart

ACTIVE COMPARATOR

Phase II Investigational Treatment:Enlonstobart Intravenous infusion

Biological: Enlonstobart

Interventions

SYS6006 BIOLOGICAL

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

Also known as: SYS6006 injection

SYS6006 + Enlonstobart

Enlonstobart BIOLOGICAL

Enlonstobart IV

Also known as: Enlonstobart injection

Enlonstobart; SYS6006 + Enlonstobart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Interventions

SYS6006 COVID-19 vaccine

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: June 3, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2030
• Last Updated: June 3, 2026

Record last verified: 2026-05