Advanced Solid TumorsPhase 1/2NCT05905614
Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors
A Phase 1/2 study testing SPH4336 Tablets in people with Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 4 sites in China.
Trial summary
This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SPH4336 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesChina
- Study dates
- 3 Nov 2020to 26 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced solid tumors；
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1；
- Life expectancy ≥ 3 months；
- Good organ function；
- According to the investigator's judgment, the patient could comply with the trial protocol;
- Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
Who cannot join
- Received other antineoplastic therapy before the first dose；
- Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication;
- Enroll in other clinical trials and receive treatment as a subject before initial medication;
- Patients with allergic constitution or history of severe allergy;
- Hepatitis B surface antigen [HBsAg] positive and HBV-DNA copy number ≥500 copies /ml or 100 IU/ml, HCV-Ab positive and HCV-RNA higher than the detection limit of the research center; A history of immunodeficiency;
- Cardiac criteria: presence of factors that may cause QTc prolongation or arrhythmia such as congestive heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, and other concomitant medications known to prolong the QT interval. The presence of any unstable cardiovascular disease;
Show all 13Show fewer
- Hypertension that cannot be effectively controlled after treatment;
- Have severe lung disease;
- Pregnant and lactating women;
- Female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial;
- Concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment;
- Had a definite history of neurological or mental disorders;
- Other circumstances considered by the investigator to be inappropriate for participation in the study.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University Cancer Hospital
Beijing, 100142
West China Hospital，Sichuan University
Chengdu, Sichuan, 610044
Chongqing University Cancer Hospital
Chongqing, 400030
Jinan Central Hospital
Jinan, Shandong, 250013
About this study
Official title: An Open-label, Dose-escalation, Phase I Clinical Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPH4336 Tablets in the Treatment of Advanced Solid Tumors
This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SPH4336 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH4336 TabletsDrug
Open-label SPH4336 Tablets ：Administered by oral
| Study group | Role | What they receive |
|---|---|---|
| SPH4336 Tablets | Experimental | SPH4336 Tablets Receives: Drug: SPH4336 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose（MTD）
Measurement of MTD of SPH4336 in all subjects
Measured: Up to 28 days
Dose-limiting toxicity (DLT)
Measurement of DLT of SPH4336 in all subjects
Measured: Up to 28 days
Secondary outcomes (7)
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: Up to 1 year
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Measured: Up to 1 year
Cmax
PK (Pharmacokinetics) parameters
Measured: predose,1,2,4,5,6,8,10,12,24 hours post-dose
Tmax
PK (Pharmacokinetics) parameters
Measured: predose,1,2,4,5,6,8,10,12,24 hours post-dose
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Measured: Up to 1 year
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Measured: Up to 1 year
Safety and tolerability
Adverse event type, incidence, duration, correlation with study drug.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start3 Nov 2020
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905614
- Sponsor's protocol ID
- SPH4336-101
- Status last verified
- Jun 2024
- First submitted
- 29 May 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang Y, Liang X, Sun ML, Gao G, Gong Y, Li HP, Liu J, Wang YS. Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. Oncologist. 2025 Jun 4;30(6):oyaf077. doi: 10.1093/oncolo/oyaf077.
PubMed 40586764
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation, Phase I Clinical Trial to Explore the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPH4336 Tablets in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05905614
- Acronym / sponsor ID
- SPH4336-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPH4336 Tablets | Experimental | Drug: SPH4336 TabletsSPH4336 Tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed advanced solid tumors；
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1；
- Life expectancy ≥ 3 months；
- Good organ function；
- According to the investigator's judgment, the patient could comply with the trial protocol;
Key exclusion criteria (13 listed)
- Received other antineoplastic therapy before the first dose；
- Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication;
- Enroll in other clinical trials and receive treatment as a subject before initial medication;
- Patients with allergic constitution or history of severe allergy;
- Hepatitis B surface antigen [HBsAg] positive and HBV-DNA copy number ≥500 copies /ml or 100 IU/ml, HCV-Ab positive and HCV-RNA higher than the detection limit of the research center; A history of immunodeficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPH4336 TabletsOpen-label SPH4336 Tablets ：Administered by oral | Drug | SPH4336 Tablets |
Primary outcome
Maximum tolerated dose（MTD）
Time frame: Up to 28 days
Measurement of MTD of SPH4336 in all subjects
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days
Measurement of DLT of SPH4336 in all subjects
7 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 1 year
Progression-free survival (PFS)
Time frame: Up to 1 year
Cmax
Time frame: predose,1,2,4,5,6,8,10,12,24 hours post-dose
Tmax
Time frame: predose,1,2,4,5,6,8,10,12,24 hours post-dose
Disease control rate (DCR)
Time frame: Up to 1 year
Duration of remission (DOR)
Time frame: Up to 1 year
Safety and tolerability
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Derived from this study: PubMed 40586764Jiang Y, Liang X, Sun ML, Gao G, Gong Y, Li HP, Liu J, Wang YS. Phase I trial of SPH4336, a novel cyclin-dependent kinase 4/6 inhibitor, in patients with advanced solid tumors. Oncologist. 2025 Jun 4;30(6):oyaf077. doi: 10.1093/oncolo/oyaf077.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SPH4336 Tablets in people with Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 4 sites in China.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose（MTD） (time frame: Up to 28 days). The study lists 2 primary outcomes in all. 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 NCT05905614, which also lists 1 linked publication.
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 17 Jun 2024.