SPGL008 given by IV or under-the-skin injection for advanced malignant tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
Run by Shenyang Sunshine Pharmaceutical Co., LTD. · NCT07038005 · Data updated 2026-11-12
This trial will test whether SPGL008 given intravenously or under the skin is safe and shows early signs of benefit in adults with advanced malignant tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. Industry-sponsored |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | September 22, 2026 |
| Study ends | June 8, 2027 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07038005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with histologically or cytologically confirmed advanced or metastatic malignant tumors, ECOG performance status 0–1, expected survival ≥3 months, and adequate organ and bone marrow function are ideal candidates.
✕Probably not a fit
Patients with uncontrolled or symptomatic brain metastases, inadequate organ or bone marrow function, recent serious toxicities from prior cancer therapy, pregnancy or breastfeeding, or known allergy to SPGL008 are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, dose-escalation, monotherapy study of SPGL008 in adults with advanced or metastatic malignant tumors. The trial has two cohorts that receive SPGL008 either intravenously or subcutaneously to compare safety and tolerability by route of administration. Key endpoints include safety, tolerability, dose-limiting toxicities, and preliminary anti-tumor activity. Eligible patients are adults with histologically confirmed advanced tumors, ECOG 0–1, and adequate organ function.
Why it matters
Potential benefit: If successful, SPGL008 could become a new treatment option that is safe and has anti-tumor activity for some patients with advanced malignant tumors.
How similar studies have gone: This is an early-phase dose-escalation trial of a novel agent, so clinical benefit from SPGL008 is unproven although similar Phase 1 oncology programs sometimes identify safe doses and early responses.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and/or females, 18-75 years old; 2. Histologically and/or cytologically documented advanced or metastatic malignant Tumors; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 4. Expected survival \>=3 months; 5. Signed informed consent form. Exclusion Criteria: 1. Known uncontrolled or symptomatic central nervous system metastatic disease; 2. 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); 3. Inadequate organ or bone marrow function; 4. Pregnant or breast-feeding woman; 5. Known allergies, hypersensitivity, or intolerance to SPGL008.
Where it's running
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Study coordinator: yongsheng Li
- Email: lys@cqu.edu.cn
- Phone: 17784310187
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.