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A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor

S

Shanghai Yingli Pharmaceutical

Status and phase

Not yet enrolling
Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: Linperlisib Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT05429398
YY-20394-013

Details and patient eligibility

About

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.

Full description

The trial can be divided into two parts: dose escalation part and dose expansion part.

Camrelizumab will be administrated intravenously in a predetermined fixed dose(200mgQ3w)in both parts.

In dose escalation part,Linperlisib will be administrated from 40mgQD,60mgQD to 80 mgQD in sequence with the classic "3+3" design.The purposes of this part are figuring out the MTD and RP2D of Linperlisib combination with Camrelizumab in treating patients with advanced solid tumor,and observing the PK characteristics of Linperlisib when using combination with Camrelizumab.

When finishing the dose escalation part,one combination dose of Linperlisib with Carelizumab will be selected to be studied on a wider scale of patients with advantage solid tumor in dose expansion part.Purposes of this part are further observing the PK characteristics of Linperlisib when using combination with Camrelizumab,while observing the preliminary efficacy of Linperlisib when using combination with Camrelizumab.

Enrollment

118 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

118 participants in 1 patient group

Linperlisib +Camrelizumab 200mgQ3w
Experimental group
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.
Treatment:
Drug: Linperlisib Tablet

Trial contacts and locations

0

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Central trial contact

Li Zhang, Doctor

Data sourced from clinicaltrials.gov

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