SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pharmaceuticals Holding Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SPH5030 tablets

Treatment groups

150 Participants
are divided into 1 treatment group