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Tests treatment safety and results for Advanced Solid Tumors
Official title A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT05944224
What this study is testing
What is SPH4336?
SPH4336 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people 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...
- 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.
You likely can't join if
- 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...
- Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be...
- Previous history of organ transplantation.
See the full eligibility criteria
- people 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...
- people agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.
- 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.
- 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...
- Accompanied by any other serious, progressive, or uncontrolled disease.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Zhengzhou, He'nan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Yongzhou, Hunan, China
- Shenzhen, Liaoning, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Zhengzhou, He'nan, China; Wuhan, Hubei, China; Changsha, Hunan, China; Yongzhou, Hunan, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.