Advanced Solid TumorsPhase 1/2NCT05944224
A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
A Phase 1/2 study testing SPH4336 and Cadonilimab in people with Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 16 sites in China.
Trial summary
This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SPH4336 and Cadonilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 16 sitesChina
- Study dates
- 17 Oct 2023to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study and sign informed consent.
- Expected survival ≥3 months.
- Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
- According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
- The laboratory test results meet the organ function requirements before starting the study treatment.
- Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.
- Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.
Who cannot join
- Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
- Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
- Had a history of other malignancies before starting the study.
- History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
- Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
- Previous history of organ transplantation.
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- Before starting the study, HBsAg positive patients with HBV DNA > 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.
- Accompanied by any other serious, progressive, or uncontrolled disease.
- Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
- History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.
- Women who are pregnant or breastfeeding.
- Any other reason for which patients are ineligible for the study as assessed by the investigator.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Mei Guan
- Recruiting
Peking University People's Hospital
Beijing
Xin Sun
Xiaodong Tang
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Bin Li
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan
Yu Jiang
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Yu Chen
- Recruiting
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong
Jingnan Shen
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhaoming Ye
- Recruiting
Zhejiang cancer Hospital
Hangzhou, Zhejiang
Meiyu Fang
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Biqiang Zheng
- Recruiting
Shanghai Sixth People's Hospital
Shanghai
Haiyan Hu, 0086-020-87343535, xuri1104@163.com
- Recruiting
Liaoning Cancer Hospital & Institute
Shenzhen, Liaoning
Xiaojing Zhang
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Jilong Yang
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Jing Chen
- Recruiting
Xijing Hospital
Xi’an, Shanxi
Hongmei Zhang
- Recruiting
The Central Hospital of Yongzhou
Yongzhou, Hunan
Sijuan Ding
- Recruiting
Henan Cancer Hospital
Zhengzhou, He'nan
Peng Zhang
About this study
Official title: A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.
This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SPH4336, Cadonilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH4336Drug
SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
CadonilimabDrug
Intravenous infusion, 6mg/Kg,28 days/cycle
| Study group | Role | What they receive |
|---|---|---|
| SPH4336 | Experimental | Not described Receives: Drug: SPH4336 |
| Cadonilimab | Experimental | Not described Receives: Drug: Cadonilimab |
| SPH4336+ Cadonilimab | Experimental | Not described Receives: Drug: SPH4336; Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Measured: Approximately 2 years
Secondary outcomes (8)
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Measured: Approximately 2 years
progression-free rate（PFR）
Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.
Measured: Approximately 2 years
Cmax
PK (Pharmacokinetics) parameters.
Measured: Approximately 2 years
Tmax
PK (Pharmacokinetics) parameters.
Measured: Approximately 2 years
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Measured: Approximately 2 years
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: Approximately 2 years
Overall Survival (OS)
Determination of the overall survival times of all patients.
Measured: Approximately 8 years
Incidence of Adverse event
Safety and tolerability
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start17 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
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
- NCT05944224
- Sponsor's protocol ID
- SPH4336-201
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.
- ClinicalTrials.gov ID
- NCT05944224
- Acronym / sponsor ID
- SPH4336-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jul 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 is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPH4336 | Experimental | Drug: SPH4336 |
| Cadonilimab | Experimental | Drug: Cadonilimab |
| SPH4336+ Cadonilimab | Experimental | Drug: SPH4336, Drug: Cadonilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects voluntarily participate in this study and sign informed consent.
- Expected survival ≥3 months.
- Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
- According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
- The laboratory test results meet the organ function requirements before starting the study treatment.
Key exclusion criteria (12 listed)
- Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
- Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
- Had a history of other malignancies before starting the study.
- History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
- Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
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 |
|---|---|---|
| SPH4336SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle | Drug | SPH4336, SPH4336+ Cadonilimab |
| CadonilimabIntravenous infusion, 6mg/Kg,28 days/cycle | Drug | Cadonilimab, SPH4336+ Cadonilimab |
Primary outcome
Progression-free survival (PFS)
Time frame: Approximately 2 years
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
8 secondary outcomes
Objective response rate (ORR)
Time frame: Approximately 2 years
progression-free rate（PFR）
Time frame: Approximately 2 years
Cmax
Time frame: Approximately 2 years
Tmax
Time frame: Approximately 2 years
Disease control rate (DCR)
Time frame: Approximately 2 years
Duration of remission (DOR)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 8 years
Incidence of Adverse event
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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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.
16 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 and Cadonilimab in people with Advanced Solid Tumors, run by Shanghai Pharmaceuticals Holding Co., Ltd at 16 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Hu (0086-020-87343535, xuri1104@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.