Advanced Solid TumorsPhase 1/2NCT07911579

A Study of SYH2051 in Combination With Irinotecan Hydrochloride Liposome Injection in Subjects With Advanced Solid Tumors

A Phase 1/2 study testing SYH2051 and Irinotecan Hydrochloride Liposome. in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is a multicenter, open-label, dose-escalation and dose expansion, and cohort-expansion phase Ib/II clinical study to evaluate the safety and antitumor efficacy of SYH2051 in combination with Irinotecan Hydrochloride Liposome Injection in Patients with Advanced Solid Tumors. 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?: SYH2051 and Irinotecan Hydrochloride Liposome.
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteChina
Study dates: 30 Nov 2026to 30 Dec 2029
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. Fully understand the clinical study and voluntarily sign the written ICF;
2. Age ≥ 18 years;
3. Have at least one measurable lesion according to RECIST 1.1;
4. ECOG performance status score of 0 to 1;
5. Have adequate organ function;
6. Expected survival of at least 3 months;
7. Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 6 months after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose;
8. Histologically or cytologically confirmed diagnosis of advanced solid tumors.

Who cannot join

1. Patients with other active malignant tumors;
2. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose;
3. Serious chronic or active infection;
4. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study;
5. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis;
6. History of non-infectious lung disease/pneumonitis requiring steroid hormone therapy or current interstitial lung disease/pneumonitis or suspected by imaging during screening;

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7. History of significant cardiovascular disease;
8. History of immunodeficiency, Active hepatitis B or hepatitis C;
9. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation;
10. Pregnant or lactating women;
11. Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jihui NA Hao, 00-86-022-23340123, haojihui@tjmuch.com
Jihui Hao, MD

Other trials in China

About this study

Official title: A Phase Ib/ II Clinical Study to Evaluate the Safety and Efficacy of SYH2051 in Combination With Irinotecan Hydrochloride Liposome in Patients With Advanced Solid Tumors

Conditions: Advanced Solid Tumors
Being tested: SYH2051, Irinotecan Hydrochloride Liposome.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SYH2051Drug
SYH2051 is an oral medication taken once daily, with dosage selected according to the dose group.
Irinotecan Hydrochloride Liposome.Drug
Irinotecan Hydrochloride Liposome is administered by intravenous infusion every 2 weeks (Q2W)

Study groups in NCT07911579
Study group	Role	What they receive
SYH2051 in combination with Irinotecan Hydrochloride Liposome.	Experimental	Not described Receives: Drug: SYH2051; Drug: Irinotecan Hydrochloride Liposome.

What is being measured

The primary outcome is the main question the study is designed to answer.

DLT
Measured: From Day 1 to Day 28
Frequency and severity of AE
Measured: From Day 1 to 12 months.
Maximal tolerable dose (MTD)
Measured: From Day 1 to 12 months.
Recommended phase 2 dose (RP2D)
Measured: From Day 1 to 12 months.
ORR
Measured: From Day 1 to 12 months.

Secondary outcomes (5)

Cmax
Measured: From Day 1 to 12 months.
AUCss,
Measured: From Day 1 to 12 months.
ORR
Measured: From Day 1 to 12 months.
PFS
Measured: From Day 1 to 12 months.
OS
Measured: From Day 1 to 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202630 Dec 2029

First posted3 Nov 2026
Study start30 Nov 2026 (estimated)
Primary completion30 Dec 2028 (estimated)
Study completion30 Dec 2029 (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 ZhongQi Pharmaceutical Technology 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: Not applicable
Intervention model: Single group
Model description: This is a multicenter, open-label, dose-escalation and dose expansion, and cohort-expansion phase Ib/II clinical study, to evaluate the safety and efficacy of SYH2051 in combination with Irinotecan Hydrochloride Liposome.
Masking: None (open label)
Enrolment: 154 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07911579
Sponsor's protocol ID: SYH2051-003
Status last verified: Oct 2026
First submitted: 27 Oct 2026
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 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 SYH2051 in Combination With Irinotecan Hydrochloride Liposome in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07911579
Acronym / sponsor ID: SYH2051-003
Conditions: Advanced Solid Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 154 participants (estimated)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Nov 2026 (estimated)
Primary completion: 30 Dec 2028 (estimated)
Study completion: 30 Dec 2029 (estimated)
First posted: 3 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a multicenter, open-label, dose-escalation and dose expansion, and cohort-expansion phase Ib/II clinical study, to evaluate the safety and efficacy of SYH2051 in combination with Irinotecan Hydrochloride Liposome.

Arm	Type	Receives
SYH2051 in combination with Irinotecan Hydrochloride Liposome.	Experimental	Drug: SYH2051, Drug: Irinotecan Hydrochloride Liposome.

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. Fully understand the clinical study and voluntarily sign the written ICF;
2. Age ≥ 18 years;
3. Have at least one measurable lesion according to RECIST 1.1;
4. ECOG performance status score of 0 to 1;
5. Have adequate organ function;

Key exclusion criteria (11 listed)

1. Patients with other active malignant tumors;
2. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose;
3. Serious chronic or active infection;
4. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study;
5. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis;

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
SYH2051SYH2051 is an oral medication taken once daily, with dosage selected according to the dose group.	Drug	SYH2051 in combination with Irinotecan Hydrochloride Liposome.
Irinotecan Hydrochloride Liposome.Irinotecan Hydrochloride Liposome is administered by intravenous infusion every 2 weeks (Q2W)	Drug	SYH2051 in combination with Irinotecan Hydrochloride Liposome.

Primary outcome

DLT
Time frame: From Day 1 to Day 28
Frequency and severity of AE
Time frame: From Day 1 to 12 months.
Maximal tolerable dose (MTD)
Time frame: From Day 1 to 12 months.
Recommended phase 2 dose (RP2D)
Time frame: From Day 1 to 12 months.
ORR
Time frame: From Day 1 to 12 months.

5 secondary outcomes

Cmax
Time frame: From Day 1 to 12 months.
AUCss,
Time frame: From Day 1 to 12 months.
ORR
Time frame: From Day 1 to 12 months.
PFS
Time frame: From Day 1 to 12 months.
OS
Time frame: From Day 1 to 18 months.

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 Nov 2026.

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

00-86-022-23340123

haojihui@tjmuch.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYH2051 and Irinotecan Hydrochloride Liposome. in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

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 11 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 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: From Day 1 to Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07911579.

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 Nov 2026.