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New treatment option for Liposarcoma
Official title APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04785196
What this study is testing
What is APG-115?
APG-115 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for liposarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Part 1 is a phase Ib standard "3 + 3" design, will be employed to determine the MTD of APG-115 by assessing the DLT of APG-115 in combination with PD-1 inhibitor(toripalimab) in advanced solid tumors. Part 2 is a Simon two-stage phase II study design.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent;
- ECOG PS 0-1;
- Phase Ib: Histologically confirmed, advanced liposarcoma or advanced solid tumor patients who failed standard of care therapy; Phase II...
- The expected survival period is more than 12 weeks;
- Measurable disease on CT or MRI by RECIST 1.1.
You likely can't join if
- Patients who have previously been treated with MDM2-p53 inhibitor;
- Known hypersensitivity reaction to PD-(L)1 inhibitors, or any prior ≥ Grade 3 irAE;
- Prior treatment consisted of any kinds of immunotherapies, like PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, OX-40 et.al( for phase II);
- Has known active central nervous (CNS) metastases and/or carcinomatous meningitis;
- Has any active or history of autoimmune disease;
- Active infection or unexplained fever \> 38.5 ° C two weeks before first dose;
See the full eligibility criteria
- Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent;
- ECOG PS 0-1;
- Phase Ib: Histologically confirmed, advanced liposarcoma or advanced solid tumor patients who failed standard of care therapy; Phase II: Histologically confirmed, advanced liposarcoma with TP53 wide-type and MDM2...
- The expected survival period is more than 12 weeks;
- Measurable disease on CT or MRI by RECIST 1.1.
- Adequate bone marrow and organ function as indicated by: the following laboratory values without continuous supportive treatment (such as blood transfusion, coagulation factors and/or platelet infusion, red/white blood...
- ANC≥1.5 x 10\^9/ L;
- PLT≥100 x 10\^9/ L;
- Hgb≥90 g/L;
- Alb≥30 g/L;
- AST and AST ≤3 \ ULN (for hepatic metastases, ALT and AST≤5\ ULN);
- Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance (CCr) ≥ 50ml / min.
- Patients who have previously been treated with MDM2-p53 inhibitor;
- Known hypersensitivity reaction to PD-(L)1 inhibitors, or any prior ≥ Grade 3 irAE;
- Prior treatment consisted of any kinds of immunotherapies, like PD-(L)1 inhibitors, anti-PD-L2 antibodies, CTLA-4, OX-40 et.al( for phase II);
- Has known active central nervous (CNS) metastases and/or carcinomatous meningitis;
- Has any active or history of autoimmune disease;
- Active infection or unexplained fever \> 38.5 ° C two weeks before first dose;
- Patients with any severe and/or uncontrolled diseases, including: hypertension and uncontrollable levels of normal anti-hypertensive medication; clinically significant cardiovascular and cerebrovascular diseases...
- Poorly controlled arrhythmia (including QTc interval ≥450 ms for males and ≥470 ms for females).
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Hangzhou, Zhejiang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Hangzhou, Zhejiang, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.