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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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).
Phase II
Mol. targeted/Immunotherapy/Biologics
Keedy, Vicki
Vanderbilt University


18 Years
Inclusion Criteria:

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

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/L

Platelets 100,000/L

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

Exclusion Criteria:

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

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)

To learn more about any of our clinical
trials, call 615-936-8422.