Trial Outcomes & Findings for Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas (NCT NCT05580588)

Last Updated: 2025-06-13

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-06-13

Participant Flow

Study terminated for efficacy lower than company standards

Study participants required to meet all I/E criteria prior to enrollment

Participant milestones

Participant milestones
Measure	SPH4336 400 mg (2 - 200 mg tablets) PO QD SPH4336: 400 mg SPH4336 PO QD
Overall Study STARTED	14
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	SPH4336 400 mg (2 - 200 mg tablets) PO QD SPH4336: 400 mg SPH4336 PO QD
Overall Study Lack of Efficacy	12

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPH4336 n=14 Participants 400 mg (2 - 200 mg tablets) PO QD SPH4336: 400 mg SPH4336 PO QD
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	11 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	SPH4336 n=14 Participants 400 mg (2 - 200 mg tablets) PO QD SPH4336: 400 mg SPH4336 PO QD
Progression-free Survival (PFS) at 12 Weeks	2 Participants

Adverse Events

SPH4336

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SPH4336 n=14 participants at risk 400 mg (2 - 200 mg tablets) PO QD SPH4336: 400 mg SPH4336 PO QD
Investigations elevated ALT	14.3% 2/14 • Number of events 2 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).
Investigations elevated AST	14.3% 2/14 • Number of events 2 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).

Other adverse events

Other adverse events
Measure	SPH4336 n=14 participants at risk 400 mg (2 - 200 mg tablets) PO QD SPH4336: 400 mg SPH4336 PO QD
Gastrointestinal disorders diarrhea	71.4% 10/14 • Number of events 10 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).
Gastrointestinal disorders vomiting	14.3% 2/14 • Number of events 2 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).
Investigations blood creatinine	14.3% 2/14 • Number of events 2 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).
Investigations neutrophil count decreased	14.3% 2/14 • Number of events 2 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).
General disorders fatigue	35.7% 5/14 • Number of events 5 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).
General disorders decreased appetite	14.3% 2/14 • Number of events 2 • Adverse events were collected for individual patients from signing of the Informed Consent until their discontinuation from the study due to disease progression, pregnancy, serious adverse events, death, or termination of the study by the Sponsor (on average, less than 1 year).

Additional Information

CSO

Shanghai Pharma Biotherapeutics USA Inc.

Phone: 8587755354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place