Clinical trial · Interventional
A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor
A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor
NCT05429398CI-TRIAL-00059271unknownPhase 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)
It is a single-arm, open-label, multicenter, phase I trial,aiming at exploring the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,observing the preliminary efficacy.
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 |
|---|---|---|---|
| Linperlisib Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Linperlisib +Camrelizumab 200mgQ3w
- description
- Linperlisib will be administrated orally from 40mgQD, 60mgQD to 80mgQD in sequence during dose excalation part and a selected dose in dose expansion part,for 21 consecutive days as a treatment cycle; Camrelizumab will be administrated intravenously 200mg every 3 weeks in all patients just before the administration of Linperlisib.
- interventionNames
- Drug: Linperlisib Tablet
Primary outcomes (2)
- measure
- DLTs
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
- description
- dose limited toxicities
- measure
- TEAEs
- timeFrame
- from day 1after taking the investigational product till 30 days after withdrew from the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old≦age≦75 years old; * Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors； * Failure of previous standard treatment (sufficient prior treatment and no better treatment than participating in clinical research); * Qualified basic organ function and body condition; * The expected survival is greater than 3 months; * Adequate washout period. Exclusion Criteria: * Prior allergy to study drug components; * Chronic metabolic diseases that are poorly controlled by medication; * Brain metastases, infection, hemorrhage, autoimmune disease or cardiovascular disease, whichever is in active state; * Digestive tract diseases that affect absorption of studied drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.