SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

Shanghai Pharmaceuticals

Status and phase: Enrolling; Early Phase 1

Conditions: HER2-positive Advanced Solid Tumors

Treatments: Drug: SPH5030 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05245058

SPH5030-101

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ECOG performance status of 0 to 1.

2. Life expectancy of more than 3 months.

3. At least one measurable lesion exists.(RECIST 1.1)

4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.

5. 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

6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.

7. Blood pregnancy test was negative within 3 days prior to first dose.

Exclusion criteria

1. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
2. Known active infection within 2 weeks prior to baseline.
3. Subjects with third space fluid that can not be controled.
4. Subjects with uncontrolled or severe cardiovascular disease.
5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
6. Subjects with severe lung disease.
7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
10. Uncured other tumors within 5 years.
11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
12. Evidence of chronic active hepatitis B or C
13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
14. Receive any live or attenuated live vaccine within 28 days prior to baseline.
15. Evidence of severe allergies.
16. Evidence of alcohol or drug abuse.
17. Evidence of neurological or psychiatric disorders.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

SPH5030 tablets

Experimental group

Description:

Subjects will take SPH5030 tablets orally on an empty stomach once or twice a day. Each subject will receive only one corresponding dose, and there were five dose groups: 50mg/ d, 100mg/ d, 200mg/ d, 300mg/ d and 400mg/ d.

Treatment:

Drug: SPH5030 tablets