RecruitingEarly Phase 1

SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

China150 participantsStarted 2022-01-21

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
✕. Known active infection within 2 weeks prior to baseline.
✕. Subjects with third space fluid that can not be controled.
✕. 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.

Dose-limiting toxicity (DLT)

Timeframe: Up to 24 days

Maximum tolerated dose（MTD）

Timeframe: Up to 24 days

Number of patients with adverse events

Timeframe: Up to 2 years

NCT IDNCT05245058

SponsorShanghai Pharmaceuticals Holding Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-21

Xingchen Wang

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
✕. Known active infection within 2 weeks prior to baseline.
✕. Subjects with third space fluid that can not be controled.
✕. 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.