SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

  • End date
    Jun 21, 2024
  • participants needed
  • sponsor
    Shanghai Pharmaceuticals Holding Co., Ltd
Updated on 15 March 2022


To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors

Condition HER2-positive Advanced Solid Tumors
Treatment SPH5030 tablets
Clinical Study IdentifierNCT05245058
SponsorShanghai Pharmaceuticals Holding Co., Ltd
Last Modified on15 March 2022


Yes No Not Sure

Inclusion Criteria

Aged ≥18 and ≤75 years
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

Exclusion Criteria

Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment, target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy
Known active infection within 2 weeks prior to baseline
Subjects with third space fluid that can not be controled by drainage or other methods
Subjects with uncontrolled or severe cardiovascular disease
Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry
Subjects with severe lung disease
Subjects 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
Subjects 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note