SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 21, 2024
  • participants needed
    105
  • sponsor
    Shanghai Pharmaceuticals Holding Co., Ltd
Updated on 15 March 2022

Summary

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

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

Eligibility

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
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