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New treatment option for HER2-positive Advanced Solid Tumors
Official title SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
ClinicalTrials.gov ID: NCT05245058
What this study is testing
What is SPH5030 tablets?
SPH5030 tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for her2-positive 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
- To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ECOG performance status of 0 to 1.
- Life expectancy of more than 3 months.
- At least one measurable lesion exists.(RECIST 1.1)
- Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
- Required laboratory values including following parameters: ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤...
You likely can't join if
- people who have received the prescribed treatment at the prescribed time prior to first dosing.
- Known active infection within 2 weeks prior to baseline.
- people with third space fluid that can not be controled.
- people with uncontrolled or severe cardiovascular disease.
- people with uncontrolled hypokalemia and hypomagnesemia before study entry.
- people with severe lung disease.
See the full eligibility criteria
- ECOG performance status of 0 to 1.
- Life expectancy of more than 3 months.
- At least one measurable lesion exists.(RECIST 1.1)
- Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
- Required laboratory values including following parameters: ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL/min
- Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.
- Blood pregnancy test was negative within 3 days prior to first dose.
- people who have received the prescribed treatment at the prescribed time prior to first dosing.
- Known active infection within 2 weeks prior to baseline.
- people with third space fluid that can not be controled.
- people with uncontrolled or severe cardiovascular disease.
- people with uncontrolled hypokalemia and hypomagnesemia before study entry.
- people with severe lung disease.
- people that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
- Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
- Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
- Uncured other tumors within 5 years.
- people with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
- Evidence of chronic active hepatitis B or C
- Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
- Receive any live or attenuated live vaccine within 28 days prior to baseline.
- Evidence of severe allergies.
- Evidence of alcohol or drug abuse.
- Evidence of neurological or psychiatric disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Zhengzhou, Henan, China
- Xiangyang, Hubei, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Linyi, Shandong, China
- Xi’an, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Bengbu, China
- Neijiang, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Shijiazhuang, Hebei, China; Harbin, Heilongjiang, China and 11 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.