Evaluating SPH5030 tablets for advanced HER2-positive solid tumors

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

This study is testing if SPH5030 tablets are safe and tolerable for people with advanced HER2-positive solid tumors that haven't responded to other treatments.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (industry)
• Locations: 17 sites (Hefei, Anhui and 16 other locations)
• Trial ID: NCT05245058 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and tolerability of SPH5030 tablets in patients with advanced HER2-positive solid tumors. Participants must have measurable lesions and a confirmed diagnosis of HER2-positive metastatic solid tumors that have either failed prior treatments or lack standard treatment options. The study will monitor various health parameters to ensure participant safety and evaluate the drug's effects. It is an early-phase trial, indicating that it is among the first steps in testing this new treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals with HER2-positive advanced solid tumors who have not responded to standard treatments.

Not a fit: Patients with uncontrolled infections or severe cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced HER2-positive solid tumors.

How similar studies have performed: While this approach is novel, similar studies targeting HER2-positive tumors have shown promise in the past.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 16 other locations

• Anhui provincial hospital — Hefei, Anhui, China (RECRUITING)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• Guangxi Cancer Hospital — Nanning, Guangxi, China (RECRUITING)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)
• Anyang Cancer Hospital — Anyang, Henan, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (RECRUITING)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (RECRUITING)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
• Linyi Cancer Hospital — Linyi, Shandong, China (RECRUITING)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (RECRUITING)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, China (RECRUITING)
• The second people's hospital of neijiang — Neijiang, China (RECRUITING)
• Tianjin Cancer Hospital Airport Hospital — Tianjin, China (RECRUITING)

Study contacts

• Principal investigator: Binghe Xu — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Xingchen Wang

Conditions: HER2-positive Advanced Solid Tumors