Clinical Trials

Inclusion Criteria:

- Provision of signed and dated, written informed consent form (ICF) in accordance with
ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or
analyses.

- Male or female patients ≥18 years old at the time of signature of the informed consent
form (ICF). Women of childbearing potential (WOCBP) and men able to father a child
must be ready and able to use 2 medically acceptable methods of birth control per ICH
M3 (R2) that result in a low failure rate of less than 1% per year when used
consistently and correctly beginning at screening, during trial participation, and
until 6 months and 12 days after last dose for women and 102 days after last dose for
men. A list of contraception methods meeting these criteria is provided in the patient
information.

- Histologically proven locally advanced or metastatic, unresectable (surgery morbidity
would outweigh potential benefits), progressive or recurrent dedifferentiated
liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted
for entry into this trial but will be confirmed by independent pathological review
while the patients receive treatment in this trial.

- Written pathology report indicating the diagnosis of DDLPS with positive mouse double
minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by
fluorescence in situ hybridization or next generation sequencing (NGS) must be
available.

- Formalin fixed paraffin embedded tumor blocks or slides must be available for
retrospective histopathological central review.

- Presence of at least one measurable target lesion according to Response Evaluation
Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one target
lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of
the target lesion.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

- Patient must be willing to donate blood samples for the pharmacokinetics,
pharmacodynamics, and tumor mutation analysis.

- Patient willing to undergo a mandatory tumor biopsy at the time point specified in the
flowchart unless exempt.

- Adequate organ function

Exclusion Criteria:

- Known mutation in the TP53 gene (screening for TP53 status is not required).

- Major surgery (major according to the investigator's assessment) performed within 4
weeks prior to randomization or planned within 6 months after screening.

- Prior systemic therapy for liposarcoma in any setting (including adjuvant,
neoadjuvant, maintenance, palliative).

- Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the
previous 5 years, except effectively treated non-melanoma skin cancers, carcinoma in
situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered
cured by local treatment.

- Previous treatment with anthracyclines in any setting (systemic treatment with other
anticancer agents is allowed if completed at least 5 years prior to study entry with
the exception of hormone therapy).

- Patients who must or intend to continue the intake of restricted medications or any
drug considered likely to interfere with the safe conduct of the trial.

- Currently enrolled in another investigational device or drug trial, or less than 30
days since ending another investigational device or drug trial(s) or receiving other
investigational treatment(s).

- Patients not expected to comply with the protocol requirements or not expected to
complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other
condition that, in the investigator's opinion, makes the patient an unreliable trial
participant).

- Further exclusion criteria apply

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/6/23. Questions regarding updates should be directed to the study team contact