Clinical trial · Interventional
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients With Advanced Solid Tumors.
NCT06487455CI-TRIAL-00093790recruitingPhase 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 efficacy and safety of SPH7485 tablets in patients with 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 |
|---|---|---|---|
| SPH7485 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPH7485
- interventionNames
- Drug: SPH7485
Primary outcomes (3)
- measure
- DLT(Dose-limiting toxicity)
- timeFrame
- Approximately 24 days
- description
- Measurement of DLT of SPH7485 in all subjects
- measure
- Maximum tolerated dose(MTD)
- timeFrame
- Approximately 24 days
- description
- Measurement of MTD of SPH7485 in all subjects
- measure
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced solid tumors; 2. At least one extracranial measurable lesion; 3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1; 4. Subjects whose laboratory examination indicators meet the prescribed standards during the screening period; 5. Life expectancy≥3 months; 6. Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1; 7. Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception; 8. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures. Exclusion Criteria: 1. Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose; 2. Subjects who have received previous drugs with the same target; 3. Subjects with active infections requiring systemic treatment; 4. Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods; 5. Subjects with uncontrolled or severe cardiovascular disease; 6. Severe lung disease; 7. Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug; 8. Subjects taking strong/moderate inhibitors or inducers of CYP3A4; 9. Subjects who use or require long-term use of hormonotherapy before screening; 10. Subjects who have had other malignancies within the past 5 years; 11. Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis; 12. Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery; 13. Abnormal virological examination during screening; History of immune deficiency; 14. Uncontrolled systemic diseases; 15. Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose; 16. Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose; 17. Subjects with a history of severe allergy or known allergy to this product and its excipients; 18. Subjects who cannot follow the study protocol to complete the required study visit and dosing; 19. Subjects with a history of alcohol or drug abuse; 20. Lactating female patients; 21. Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator; 22. Subjects deemed unsuitable for this clinical study by the investigator for other reasons.
References
Publications (0)
Data not yet available
No reference posted for this study.