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Liposarcoma, DedifferentiatedPhase 2NCT05580588

Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas

A Phase 2 study testing SPH4336 in people with Liposarcoma, Dedifferentiated, run by Shanghai Pharma Biotherapeutics USA Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liposarcoma, Dedifferentiated
What is being tested?
SPH4336
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
9 sitesUnited States
Study dates
31 Aug 2023to 31 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent
  • ≥ 18 years of age
  • ECOG performance status 0 or 1
  • Histologically confirmed, locally advanced or metastatic sarcoma
  • Dedifferentiated or well-differentiated/dedifferentiated liposarcomas
  • No more than 3 prior lines of treatment
Show all 21Show fewer
  • Evidence of progression as evidenced by at least one of the following within the past 3 months:
  • An increase of at least 20% in measurable tumors
  • The appearance of new lesions
  • Unequivocal progression of non-measurable lesions
  • Measurable disease per RECIST v1.1
  • If residual treatment-related toxicity from prior therapy:
  • All treatment-related toxicity resolved to Grade 1 or baseline (alopecia excepted)
  • ANC ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Hgb ≥ 9.0 g/dL (in the absence of pRBC transfusion over the prior 4 weeks)
  • Estimated glomerular filtration rate of ≥ 60 mL/min (based on the Cockcroft and Gault formula for individualized estimates of GFR)
  • Total bilirubin ≤ 1.5 x the Upper Limit of Normal (ULN) or ≤ 3 x ULN if known Gilbert's disease
  • AST and ALT ≤ 3 x ULN or ≤ 5 x ULN if malignant involvement of the liver
  • Sterile or willing to use effective contraception (approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings or hormonally-impregnated intrauterine device (IUD), or an IUD in women of childbearing potential and a condom in men) during the study and for 3 months following the last dose of study drug
  • Availability of archived tumor tissue or willingness to undergo a baseline tumor biopsy, and in the first 10 study subjects, to determine baseline tumor biomarker levels and a willingness to undergo a second tumor biopsy at C1D15 to assess treatment-induced changes in tumor biomarker levels

Who cannot join

  • Prior treatment with a CDK4/6-targeted agent
  • Patient's tumor known to be CDK4 negative
  • Anticancer therapy (e.g., chemotherapy, biologics, irradiation) within 14 days or 5 half-lives (whichever is greater) of screening
  • Major surgery within 28 days of screening
  • Requirement for systemic treatment with strong CYP3A4 inhibitors or inducers of CYP3A4 at study entry
  • Central nervous system metastases or leptomeningeal disease, unless appropriately treated and neurologically stable without steroids for ≥ 28 days
Show all 16Show fewer
  • Other malignancy unless disease-free for ≥ 2 years and not expected to relapse or require treatment during study participation
  • Active systemic infection or severe localized infection
  • Known HIV-positive with CD4+ cell counts < 350 cells/uL or a history of an AIDS-defining opportunistic infection
  • Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with viral load above the limit of quantification
  • Active COVID-19 infection
  • Major cardiac abnormalities (e.g., uncontrolled angina, unstable arrhythmias, myocardial infarction, NYHA Class ≥ 3 CHF) ≤ 6 months of C1D1
  • Persistent (3 ECGs ≥ 5 mins apart) prolongation of the QTcF (Fridericia) > 470 msec
  • [Females] Pregnant or nursing
  • Any other medical or psychiatric condition, or laboratory abnormality that would result in an unacceptable risk with study participation
  • Presence of active gastrointestinal disease or other condition expected to interfere significantly with absorption, distribution, metabolism or excretion of oral therapy (e.g., ulcerative disease, uncontrolled nausea, vomiting, chronic diarrhea, malabsorption syndrome)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Seidman Cancer Center, University Hospitals

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • City of Hope

    Duarte, California, 91010

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • University of Miami

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

Other trials in United States

About this study

Official title: A Phase 2 Multicenter, Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas

Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with specific types of liposarcomas (tumors expressing the target of the study drug).

Read the detailed description

Study SPH4336-US-01 is a multicenter, non-randomized, open-label Phase 2 study of SPH4336 with a safety lead-in in subjects with CDK4-positive liposarcomas (dedifferentiated or well-differentiated/dedifferentiated liposarcomas). SPH4336 is an orally administered, molecularly targeted chemotherapy drug called a cyclin-dependent kinase inhibitor (CDK4/6 inhibitor), which acts to block the ability of cancer cells to divide and thus prevents tumors from growing. SPH4336 (tablets) will be administered orally once each day in successive 28-day cycles until demonstration of progressive disease or the development of unacceptable toxicity.

The study will incorporate a safety lead-in for the initial 10 subjects. Safety will be evaluated after 10 subjects (minimum 1 cycle completed) by a Safety Review Committee (SRC). The study will be stopped if unacceptable toxicity is observed in more than 2 subjects.

Tumor assessments according to RECIST v1.1 will be performed at baseline and every 6 weeks (from Cycle 1, Day 1 (C1D1)) for 36 weeks, then every 12 weeks thereafter. Plasma samples for pharmacokinetics will be collected in all subjects. Baseline (pretreatment) tumor tissue (archival or fresh) will be collected from all subjects to confirm histologically a liposarcoma with a dedifferentiated component and CDK4 positivity. Tumor tissue biomarkers (e.g., phospho-Rb, Ki-67) will be analyzed in the first 10 study subjects in baseline (pretreatment) and C1D15 tumor tissue samples.

Being tested
SPH4336
Keywords
CDK4/6 inhibitor
Medical subject headings
Liposarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPH4336Drug

    400 mg SPH4336 PO QD

Study groups in NCT05580588
Study groupRoleWhat they receive
SPH4336Experimental400 mg (2 - 200 mg tablets) PO QD
Receives: Drug: SPH4336

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) at 12 Weeks

    Number of total patients who are progression-free, as defined as RECIST v1.1 (a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions), at 12 weeks

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start31 Aug 2023
  3. Primary completion4 Oct 2024
  4. Study completion31 Oct 2024

Why it stopped: Although no safety issues with SPH4336 were identified, efficacy in liposarcoma patient was less than anticipated.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580588
Sponsor's protocol ID
SPH4336-US-01
Status last verified
Jun 2025
First submitted
11 Oct 2022
Last updated
13 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SPH4336 in people with Liposarcoma, Dedifferentiated, run by Shanghai Pharma Biotherapeutics USA Inc. at 9 sites in United States.

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 21 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580588.

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 13 Jun 2025.

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