Advanced Solid TumorsPhase 1/2NCT07622225
SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors
A Phase 1/2 study testing SYS6006 and Enlonstobart in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SYS6006 and Enlonstobart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2026to 31 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- SYS6006, Enlonstobart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6006Biological
Also called SYS6006 injection
Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection
EnlonstobartBiological
Also called Enlonstobart injection
Enlonstobart IV
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: SYS6006; Biological: Enlonstobart |
| Enlonstobart | Active comparator | Phase II Investigational Treatment:Enlonstobart Intravenous infusion Receives: Biological: Enlonstobart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase)
Measured: Within 21 days after the start of the treatment
Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) .
Measured: Through study completion, an average of l year
Phase Ib:Incidence and frequency of serious adverse events (SAEs)
Measured: Through study completion, an average of l year
Phase Ib:Maximum tolerated dose (MTD)
Measured: Every 21 days while on treatment (estimated 6 months)
Phase Ib: Recommended Phase II dose (RP2D)
Measured: Every 21 days while on treatment (estimated 6 months)
Phase II: ORR as assessed by the investigator according to RECIST v1.1
Measured: through study completion, an average of 1year.
Phase II: Incidence and frequency of TEAEs.
Measured: through study completion, an average of l year
Phase II:Incidence and frequency of SAEs.
Measured: through study completion, an average of l year
Secondary outcomes (9)
Disease control rate (DCR) per RECIST 1.1
Measured: Up to approximately 24 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
Measured: Up to approximately 24 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
Measured: Up to approximately 24months after the first participant is enrolled
Time to response(TTR)
Measured: Up to approximately 24months after the first participant is enrolled
Overall survival(OS)
Measured: Up to approximately 24 months after the first participant is enrolled
Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0)
Measured: Up to approximately 24 months after the first participant is enrolled
PK parameters: The plasma concentration of enlonstobart
Measured: 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)
Measured: 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
Measured: through study completion, an average of l year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start29 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622225
- Sponsor's protocol ID
- SYS6006-009
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07622225
- Acronym / sponsor ID
- SYS6006-009
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYS6006 + Enlonstobart | Experimental | Biological: SYS6006, Biological: EnlonstobartPhase 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). |
| Enlonstobart | Active comparator | Biological: EnlonstobartPhase II Investigational Treatment:Enlonstobart Intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYS6006Also: SYS6006 injectionDrug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection | Biological | SYS6006 + Enlonstobart |
| EnlonstobartAlso: Enlonstobart injectionEnlonstobart IV | Biological | Enlonstobart, SYS6006 + Enlonstobart |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SYS6006 and Enlonstobart in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.