Clinical trial · Interventional
A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors.
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of SPH6516 Tablets in Subjects With Advanced Solid Tumors.
NCT06266923CI-TRIAL-00074094completedEarly Phase 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)
To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.
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 Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPH6516 tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPH6516 tablets
- interventionNames
- Drug: SPH6516 tablets
Primary outcomes (1)
- measure
- MTD(Maximum tolerated dose)
- timeFrame
- Approximately 2 years
- description
- Maximum tolerated dose
Secondary outcomes (7)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- Approximately 2 years
- description
- Adverse event type, incidence, duration
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Advanced solid tumors; 2. The ECOGscore is 0 to 1. 3. Expected survival ≥3 months. 4. Good organ function before first use of the investigational drug. 5. Any toxicity associated with previous antitumor therapy must have returned to ≤ grade 1. 6. Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in person. Exclusion Criteria: 1. Subjects who have received certain treatment in the prescribed period prior to their first medication; 2. Subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication; 3. Subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication; 4. Subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; Subjects with factors affecting drug administration and absorption; 5. Subjects with allergic constitution or a history of severe allergies; 6. Subjects with active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or a history of immunodeficiency; 7. Subjects with a history or evidence of high risk cardiovascular disease; 8. Subjects with severe lung disease; 9. Pregnant and lactating female subjects; Female subjects of childbearing age or male subjectswith fertile partners who were unwilling to take effective contraceptive measures throughout the entire trial period; 10. Subjects with a clear history of neurological or psychiatric disorders; 11. Other situations in which the investigator did not consider it appropriate to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.