Advanced Malignant TumorsPhase 1NCT07038005
A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors
A Phase 1 study testing SPGL008 in people with Advanced Malignant Tumors, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- SPGL008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 8 Jun 2027
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and/or females, 18-75 years old;
- Histologically and/or cytologically documented advanced or metastatic malignant Tumors;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Expected survival >=3 months;
- Signed informed consent form.
Who cannot join
- Known uncontrolled or symptomatic central nervous system metastatic disease;
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI-CTCAE] v.5.0);
- Inadequate organ or bone marrow function;
- Pregnant or breast-feeding woman;
- Known allergies, hypersensitivity, or intolerance to SPGL008.
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, 1 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
yongshen LI, 17784310187, lys@cqu.edu.cn
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.
Read the detailed description
This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.
- Conditions
- Advanced Malignant Tumors
- Being tested
- SPGL008
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPGL008Drug
Biological product
| Study group | Role | What they receive |
|---|---|---|
| dose level 1 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 2 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 3 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 4 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 5 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 6 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 7 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 8 of SPGL008 （Intravenous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 1 of SPGL008 （Subcutaneous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 2 of SPGL008 （Subcutaneous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 3 of SPGL008 （Subcutaneous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 4 of SPGL008 （Subcutaneous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 5 of SPGL008 （Subcutaneous administration） | Experimental | Not described Receives: Drug: SPGL008 |
| dose level 6 of SPGL008 （Subcutaneous administration） | Experimental | Not described Receives: Drug: SPGL008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.
Measured: During the first cycle. Each cycle is 21 days
Maximum tolerated dose (MTD)
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Measured: During the first cycle. Each cycle is 21 days
Secondary outcomes (5)
Objective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Measured: Up to 2 years
Cmax
Measured: Up to 2 years
Tmax
Measured: Up to 2 years
T1/2
Measured: Up to 2 years
AUC
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start30 Jul 2025
- Primary completion22 Sep 2026 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038005
- Sponsor's protocol ID
- SPGL008-101
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07038005
- Acronym / sponsor ID
- SPGL008-101
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 26 Jun 2025 (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 includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.
Detailed description
This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| dose level 1 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 2 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 3 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 4 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 5 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 6 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 7 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 8 of SPGL008 （Intravenous administration） | Experimental | Drug: SPGL008 |
| dose level 1 of SPGL008 （Subcutaneous administration） | Experimental | Drug: SPGL008 |
| dose level 2 of SPGL008 （Subcutaneous administration） | Experimental | Drug: SPGL008 |
| dose level 3 of SPGL008 （Subcutaneous administration） | Experimental | Drug: SPGL008 |
| dose level 4 of SPGL008 （Subcutaneous administration） | Experimental | Drug: SPGL008 |
| dose level 5 of SPGL008 （Subcutaneous administration） | Experimental | Drug: SPGL008 |
| dose level 6 of SPGL008 （Subcutaneous administration） | Experimental | Drug: SPGL008 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and/or females, 18-75 years old;
- Histologically and/or cytologically documented advanced or metastatic malignant Tumors;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Expected survival >=3 months;
- Signed informed consent form.
Key exclusion criteria (5 listed)
- Known uncontrolled or symptomatic central nervous system metastatic disease;
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI-CTCAE] v.5.0);
- Inadequate organ or bone marrow function;
- Pregnant or breast-feeding woman;
- Known allergies, hypersensitivity, or intolerance to SPGL008.
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 |
|---|---|---|
| SPGL008Biological product | Drug | dose level 1 of SPGL008 （Intravenous administration）, dose level 1 of SPGL008 （Subcutaneous administration）, dose level 2 of SPGL008 （Intravenous administration）, dose level 2 of SPGL008 （Subcutaneous administration）, dose level 3 of SPGL008 （Intravenous administration）, dose level 3 of SPGL008 （Subcutaneous administration）, dose level 4 of SPGL008 （Intravenous administration）, dose level 4 of SPGL008 （Subcutaneous administration）, dose level 5 of SPGL008 （Intravenous administration）, dose level 5 of SPGL008 （Subcutaneous administration）, dose level 6 of SPGL008 （Intravenous administration）, dose level 6 of SPGL008 （Subcutaneous administration）, dose level 7 of SPGL008 （Intravenous administration）, dose level 8 of SPGL008 （Intravenous administration） |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: During the first cycle. Each cycle is 21 days
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.
Maximum tolerated dose (MTD)
Time frame: During the first cycle. Each cycle is 21 days
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 years
Cmax
Time frame: Up to 2 years
Tmax
Time frame: Up to 2 years
T1/2
Time frame: Up to 2 years
AUC
Time frame: Up to 2 years
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 9 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPGL008 in people with Advanced Malignant Tumors, run by Shenyang Sunshine Pharmaceutical 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 5 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: looking for participants now, as of the sponsor's last update on 9 Feb 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 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.
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 yongsheng Li (17784310187, lys@cqu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: During the first cycle. Each cycle is 21 days). The study lists 2 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 9 Feb 2026.