Advanced Solid TumorPhase 1NCT05429398
A Study of Linperlisib Combination With Camrelizumab in Patients With Solid Tumor
A Phase 1 study testing Linperlisib Tablet in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Linperlisib Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor
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.
Read the detailed 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- Linperlisib Tablet
- Keywords
- PI3K inhibitor, PD-1 inhibitor, advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linperlisib TabletDrug
Also called Camrelizumab for Injection
- Linperlisib Tablet Oral administration, once a day, for 21 consecutive days as a treatment cycle;
- Camrelizumab for Injection 200 mg intravenously every 3 weeks. Camrelizumab should be administered prior to Linperlisib.
| Study group | Role | What they receive |
|---|---|---|
| Linperlisib +Camrelizumab 200mgQ3w | Experimental | 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. Receives: Drug: Linperlisib Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
dose limited toxicities
Measured: At the end of Cycle 1 (each cycle is 21 days)
TEAEs
treatment emergent adverse events
Measured: from day 1after taking the investigational product till 30 days after withdrew from the study
Secondary outcomes (3)
Drug exposure
Peak Plasma Concentration (Cmax)
Measured: At the end of Cycle 1 (each cycle is 21 days)
PK parameters
Area under the plasma concentration versus time curve (AUC).etc.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Effectiveness evaluation index
ORR、DOR、DCR、TTR、PFS、OS
Measured: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start30 Jun 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Doctor, Principal investigator, Cancer Hospital affiliated to Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429398
- Sponsor's protocol ID
- YY-20394-013
- Status last verified
- Jun 2022
- First submitted
- 5 May 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter,Phase I Study of Linperlisib Combination With Camrelizumab in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05429398
- Acronym / sponsor ID
- YY-20394-013
- Conditions
- Advanced Solid Tumor
- Keywords
- PI3K inhibitor, PD-1 inhibitor, advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linperlisib +Camrelizumab 200mgQ3w | Experimental | Drug: Linperlisib TabletLinperlisib 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linperlisib TabletAlso: Camrelizumab for Injection1. Linperlisib Tablet Oral administration, once a day, for 21 consecutive days as a treatment cycle; 2. Camrelizumab for Injection 200 mg intravenously every 3 weeks. Camrelizumab should be administered prior to Linperlisib. | Drug | Linperlisib +Camrelizumab 200mgQ3w |
Primary outcome
DLTs
Time frame: At the end of Cycle 1 (each cycle is 21 days)
dose limited toxicities
TEAEs
Time frame: from day 1after taking the investigational product till 30 days after withdrew from the study
treatment emergent adverse events
3 secondary outcomes
Drug exposure
Time frame: At the end of Cycle 1 (each cycle is 21 days)
PK parameters
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Effectiveness evaluation index
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang, Doctor principal investigator
Cancer Hospital affiliated to Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Linperlisib Tablet in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Doctor (13902282893, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.