Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer.

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study comprises two phases: Phase 1a and Phase 1b. The purpose of the study is to observe the safety， tolerability and efficacy of FS-1502.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Fosun Pharmaceutical Development Co, Ltd.

Criteria

Inclusion Criteria:

1. Age ≥18 years at the time of study registration (men and women eligible);

2. Phase Ia dose-escalation study:

Patients with HER2 expressed advanced malignant solid tumor had failed to standard therapy (including surgery, chemotherapy, radiation therapy or biotherapy), or can not receive standard therapy, or no standard therapy is available.

1. HER2 overexpression: IHC3+, IHC2+/FISH+, or FISH+

2. HER2 low expression: IHC1+, IHC2+/FISH-

Phase Ib dose-expanded study:

Histologically or cytologically confirmed breast cancer patients who have failed to prior trastuzumab treatment. Including patients with locally advanced or metastatic breast cancer and those who have relapsed after standard adjuvant chemotherapy (treatment for more than 3 months). Details as follows:

1. HER2 positive (defined as IHC3+ or IHC2+/FISH+);

2. At least one standard trastuzumab treatment or other biosimilar has been received and the treatment failed.

3. Provide evidence of disease progression or intolerable toxicity as confirmed by the investigator or medical history recorded prior to enrollment.

The enrollment can be based on written HER2 test report from certified local lab, and if patients had no HER2 test report, they should provide sufficient paraffin sections or fresh tumor tissue specimens which should be sent to the local lab or the central laboratory for testing and confirmation.

3. The ECOG performance status must be 0 or 1.

4. Expected survival for at least 12 weeks.

5. Has adequate organ and bone marrow function: absolute neutrophil count (ANC) ≥ 1.5x109/L; hemoglobin ≥ 90g/L (without red blood cell infusion within 14 days); platelet count ≥ 100x109/L; Total bilirubin ≤ 1.5x upper limit normal (ULN), or ≤ 3x ULN if with Gilbert syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN; AST and ALT ≤ 5x ULN if liver metastasis; Serum creatinine < 1.5x ULN and creatinine clearance ≥ 45mL/min (Cockroft-Gault formula calculation); albumin ≥ 3g/dL; left ventricular ejection fraction (LVEF) >50%.

6. Has at least one measurable lesion by RECIST version 1.1.

7. Male or female patients with fertility must agree to use effective contraceptive methods during the study period and within 30 days of the last dose of study therapy, such as dual barrier contraceptive methods, condoms, oral or injectable contraceptives, and intrauterine devices.

8. Ability to understand and voluntarily sign written informed consent.

Exclusion Criteria:

1. Patients who received chemotherapy, targeted therapy, radiotherapy, etc., 14 days or within 5 half-lives periods, whichever is shorter, prior to the start of dosing; Patients who received major surgery, tumor immunotherapy, or monoclonal antitumor therapy within 4 weeks prior to the start of dosing;

2. Patients who have participated in other clinical trials 4 weeks before the start of study drug administration or within 5 half-lives periods, whichever is shorter; patients who have received similar treatments.

3. Uncontrolled central nervous system metastasis or injury (Patients who have been treated with local therapy and have a stable disease for more than 3 months are allowed to enroll).

4. Patients with uncontrolled diabetes mellitus (Patients who are receiving an insulin regimen or a hypoglycemic regimen and are evaluated as having good glycemic control by a specialist are allowed to enroll).

5. Has not recovered from previous anti-tumor treatment-related toxic reactions (> NCI-CITCAE 5.0 Grade 2), except for hair loss. The neurotoxicity of patients who have previously received chemotherapy needs to be restored to NCI-CTCAE 5.0 level 2 or below.

6. Patients who are taking medications that prolong the QTc interval (mainly Ia, Ic, and III antiarrhythmic drugs) or patients with risk factors for QTc interval prolongation, such as uncorrectable hypokalemia, hereditary long QT syndrome. Drugs that potentially prolong the QTc interval can be found at https://crediblemeds.org/index.php/tools/pdfdownload?f=cql_en

7. Cardiac function and disease meeting one of the following conditions:

1. Three 12-lead electrocardiogram (ECG) measurements at the research center during the screening period. Calculate the average of three measurements based on the QTc formula, QTc > 470 milliseconds.

2. New York Heart Association (NYHA) graded ≥3 congestive heart failure.

3. Clinically significant arrhythmias, including but not limited to complete left bundle branch conduction abnormality, II degree atrioventricular block.

8. Pregnant or lactating woman.

9. Allergic to any excipients of FS-1502.

10. Clinically significant active bacterial, fungal or viral infections, including hepatitis B (hepatitis B virus surface antigen positive and hepatitis B virus DNA over 1000 IU/ml) or hepatitis C (hepatitis C virus RNA positive), human immunodeficiency virus infection ( HIV positive).

11. Any other disease or condition of clinical significance (eg, active or uncontrollable infection, etc.) considered by investigator that may affect protocol compliance or affect patient signature of ICF.