Clinical trial · Interventional
A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
NCT07038005CI-TRIAL-00102835recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumors | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPGL008 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (14)
- type
- EXPERIMENTAL
- label
- dose level 1 of SPGL008 （Intravenous administration）
- interventionNames
- Drug: SPGL008
- type
- EXPERIMENTAL
- label
- dose level 2 of SPGL008 （Intravenous administration）
- interventionNames
- Drug: SPGL008
- type
- EXPERIMENTAL
- label
- dose level 3 of SPGL008 （Intravenous administration）
- interventionNames
- Drug: SPGL008
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.