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APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors

ConditionsLiposarcomaAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.

About this trial

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. At RP2D of APG-115 in combination with toripalimab in advanced liposarcoma, approximately 34 patients will be treated with the combination until disease progression, unacceptable toxicity, or another discontinuation criterion is met.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 Amplification;

The expected survival period is more than 12 weeks;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • APG-115

    Drug

    Dose escalation of APG-115 in combination with label dose of toripalimab, four dose levels of APG-115 will be tested: 50, 100, 150, and 200mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as 3 weeks a cycle.

  • Toripalimab

    Drug

    Toripalimab is administrated following CDE approved label dose, i.e.: 240 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.

Treatment groups

95 Participants
are divided into 1 treatment group
Group A: APG-115+ToripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity (Phase I)

DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 3 weeks of study treatment. These will be assessed via CTCAE version 5.0.

Time frame
21 days
2

Recommended Phase II Dose

Phase I is aimed to generate data to select the recommended Phase II dose.

Time frame
21 days
3

Overall Response Rate (Phase II)

Phase II is to assess overall response rate of APG-115 in combination with toripalimab defined as the percentage of subjects with a best overall confirmed CR or a PR at any time as per RECIST v1.1.

Time frame
up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ascentage Pharma Group Inc.

Lead sponsor

Suzhou Yasheng Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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