CompletedPhase 1

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

China161 participantsStarted 2019-10-11

Plain-language 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.

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.

✓. Age ≥18 years at the time of study registration (men and women eligible);
✓. Phase Ia dose-escalation study:
✓. HER2 expression: IHC3+, IHC2+/FISH+
✓. HER2 expression: IHC1+, IHC2+/FISH-
✓. HER2 positive (defined as IHC3+ or IHC2+/FISH+);
✓. For patients with advanced breast cancer who had previously failed anti-HER2 therapy and had received at least 2-line therapy, postoperative adjuvant therapy which could be considered as a treatment line number if disease progression during treatment and within 12 months after completion of treatment.
✓. 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.

✕. 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.
✕. 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 previously treated with anti-HER2 ADC drugs.
✕. Patients with central nervous system metastasis.
✕. Clinically uncontrolled mass pleural effusion, pericardial effusion, or abdominal effusion (2 weeks before first administration).
✕. Non-recovery of toxic effects from previous antitumor therapy (\> NCI-CTCAE 5.0 grade 1) alopecia, neurotoxicity, or other toxicity that had become chronic as assessed by the investigator and did not affect the safety of the investigational medication was admitted to NCI-CTCAE 5.0 grade 2 or below.
✕. Patients with corneal epitheliopathy (other than mild punctiform keratopathy or existing eye diseases affecting the evaluation of ocular toxicity after trial administration) or who were unwilling to stop wearing contact lenses during the study.
✕. Patients take medications that prolong the QTc interval (mainly Ia, Ic, Class III antiarrhythmic drugs) or have risk factors that prolong the QTc interval, such as uncorrectable hypokalemia, hereditary long QT syndrome;

DLT of first single dose of FS-1502.

Timeframe: At the end of Cycle 1 (each cycle is 28 days or 21 days) in Phase Ia.

MTD of single dose of FS-1502

Timeframe: At the end of Cycle 1 (each cycle is 28 days or 21 days) in Phase Ia.

Recommend Phase 2 Dose(RP2D) of single dose of FS-1502

Timeframe: Throughout the Phase Ia

Overall response rate (ORR) assessed by IRC

Timeframe: Approximately 2 years in Phase Ib.

NCT IDNCT03944499

SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-20

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.

✓. Age ≥18 years at the time of study registration (men and women eligible);
✓. Phase Ia dose-escalation study:
✓. HER2 expression: IHC3+, IHC2+/FISH+
✓. HER2 expression: IHC1+, IHC2+/FISH-
✓. HER2 positive (defined as IHC3+ or IHC2+/FISH+);
✓. For patients with advanced breast cancer who had previously failed anti-HER2 therapy and had received at least 2-line therapy, postoperative adjuvant therapy which could be considered as a treatment line number if disease progression during treatment and within 12 months after completion of treatment.
✓. 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.

✕. 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.
✕. 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 previously treated with anti-HER2 ADC drugs.
✕. Patients with central nervous system metastasis.
✕. Clinically uncontrolled mass pleural effusion, pericardial effusion, or abdominal effusion (2 weeks before first administration).
✕. Non-recovery of toxic effects from previous antitumor therapy (\> NCI-CTCAE 5.0 grade 1) alopecia, neurotoxicity, or other toxicity that had become chronic as assessed by the investigator and did not affect the safety of the investigational medication was admitted to NCI-CTCAE 5.0 grade 2 or below.
✕. Patients with corneal epitheliopathy (other than mild punctiform keratopathy or existing eye diseases affecting the evaluation of ocular toxicity after trial administration) or who were unwilling to stop wearing contact lenses during the study.
✕. Patients take medications that prolong the QTc interval (mainly Ia, Ic, Class III antiarrhythmic drugs) or have risk factors that prolong the QTc interval, such as uncorrectable hypokalemia, hereditary long QT syndrome;

What they're measuring

DLT of first single dose of FS-1502.

Timeframe: At the end of Cycle 1 (each cycle is 28 days or 21 days) in Phase Ia.

MTD of single dose of FS-1502

Timeframe: At the end of Cycle 1 (each cycle is 28 days or 21 days) in Phase Ia.

Recommend Phase 2 Dose(RP2D) of single dose of FS-1502

Timeframe: Throughout the Phase Ia

Overall response rate (ORR) assessed by IRC

Timeframe: Approximately 2 years in Phase Ib.