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

NCT05580588 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: SPH4336-US-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Liposarcoma, Dedifferentiated

Keywords

CDK4/6 inhibitor

Outcome Measures

Primary Outcomes (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

  12 weeks

Study Arms (1)

SPH4336

EXPERIMENTAL

400 mg (2 - 200 mg tablets) PO QD

Drug: SPH4336

Interventions

SPH4336 DRUG

400 mg SPH4336 PO QD

SPH4336

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/μL
• Platelets ≥ 100,000/μL

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pharma Biotherapeutics USA Inc.: lead

Study Sites (9)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Seidman Cancer Center, University Hospitals

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Liposarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Results Point of Contact

• Title: CSO
• Organization: Shanghai Pharma Biotherapeutics USA Inc.

kenneth@sphbio.com

8587755354

Study Officials

• Kenneth W Locke, PhD

  Shanghai Pharma Biotherapeutics USA Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: August 31, 2023
• Primary Completion: October 4, 2024
• Study Completion: October 31, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)