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

NCT03944499 | Completed Phase 1

• 1 other identifier: FS-CY1502-Ph1-01
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Solid Tumor; Breast Cancer

Outcome Measures

Primary Outcomes (4)

• DLT of first single dose of FS-1502.

  DLT is defined as a dose-limiting toxicity event occurring during the DLT observation period that, as determined by the Investigator and/or Sponsor to be at least possibly related to FS-1502, is classified using NCI-CTCAE version 5.0 as conforming to AE or laboratory anomalies specified in the protocol.

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

• MTD of single dose of FS-1502

  MTD was defined as the maximum dose of \< 33% DLT events observed in patients with evaluable DLT events (i.e., 1 in 6 patients at most or 0 in 3 patients).

  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

  If the MTD is not observed, the appropriate therapeutic exposure dose or RP2D is determined based on the antitumor efficacy evaluation, safety data, and PK data.

  Throughout the Phase Ia

• Overall response rate (ORR) assessed by IRC

  Percentage of patients with confirmed CR or PR as evaluated by RECIST version 1.1

  Approximately 2 years in Phase Ib.

Secondary Outcomes (14)

• TEAE

  Approximately 3 years.

• SAE and AE that leading to treatment permanent discontinuation

  Approximately 2 years.

• Incidence of deaths and causes

  Approximately 3 years.

• Progression free survival (PFS)

  Approximately 2 years.

• Overall survival (OS)

  Approximately 3 years.

Study Arms (1)

FS-1502

EXPERIMENTAL

Phase Ia: Patients enrolled on the 1.2 and 2.0 regimens: FS-1502 monotherapy every 4 weeks with intravenous drip, 28 days as a cycle; Patients enrolled on the 3.0 regimens: starting from the 1.0mg/kg dose group, FS-1502 monotherapy every 3 weeks with intravenous drip, 21 days as a cycle; Phase Ib: FS-1502 monotherapy, the dose and frequency of administration for Stage Ib will be obtained according to Phase Ia (RP2D). All patients will continue treatment until no clinical benefit occurs, or intolerable toxicity occurs, or death occurs, or the investigator decides, or patients voluntarily withdraw from the study. Study end is defined as the last patient's treatment ended or 2 years after the last patient's treatment began(depending on which happens earlier).

Drug: FS-1502

Interventions

FS-1502 DRUG

Dose-Escalation Phase (Phase 1a)： FS-1502 dose-escalation will be proceeded on standard 3+3 design with starting dose of 0.1 mg/kg, IV, once per 28 days, 28 days as a cycle in the V1.2 and V2.0 regimens; IV, once per 21 days, 21 days as a cycle in the V3.0 regimens.. Dose level 1: 0.1 mg/kg; Dose level 2: 0.2 mg/kg; Dose level 3: 0.4 mg/kg; Dose level 4: 0.6 mg/kg; Dose level 5: 0.8 mg/kg; Dose level 6: 1.0 mg/kg; Dose level 7: 1.3 mg/kg. If 1.3mg/kg is still tolerated safely and in line with linear kinetic characteristics, and combined with the results of PK, PD, safety and effectiveness, a comprehensive assessment is made to determine whether to continue the dose escalating. The subsequent dose increase ratio is 33% (the dose increase ratio can be adjusted according to the previous data results) until MTD or RP2D. Dose-expansion Phase (Phase 1b) : RP2D determined in phase 1a, IV.

FS-1502

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of study registration (men and women eligible);
• Phase Ia dose-escalation study:
• Patients with HER2-expressing advanced malignant solid tumors who had failed to standard therapy(including surgery, chemotherapy, radiation therapy or biotherapy) , or can not receive standard therapy, or no standard therapy is available.
• HER2 expression: IHC3+, IHC2+/FISH+
• HER2 expression: IHC1+, IHC2+/FISH-
• Phase Ib dose-expanded study:
• Histologically or cytologically confirmed HER2-positive patients with advanced breast cancer who had previously received at least 2 line therapy and had failed anti-HER2 therapy. Details as follows:
• 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.
• Pivotal clinical study:
• Patients with locally advanced or relapsed metastatic breast cancer who have been histologically or cytologically confirmed to be HER2-positive and who have received two or more lines of anti-HER2 therapy in the past. Details as follows:
• Previous treatment with two or more lines of anti-HER2 therapy, neoadjuvant therapy or adjuvant therapy can be used as a treatment line number if the disease progresses during or within 12 months after treatment.
• Evidence of investigator-confirmed or documented disease progression or intolerance of toxicity prior to enrollment.

You may not qualify if:

• 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;
• Cardiac function and disease conform to one of the following conditions:
• Three 12-lead electrocardiogram (ECG) measurements were performed at the research center during the screening period, and three mean values were calculated according to the QTc formula adopted by the instrument, QTc \> 470 ms;
• New York Heart Association (NYHA)Grade ≥ 2 for congestive heart failure;
• arrhythmia of clinical significance grade ≥ 2.
• History of myocardial infarction or severe arteriovenous thrombosis within 6 months.
• Pregnant or lactating women;
• Known allergy to any excipients of FS-1502;

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead

Study Sites (12)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

Jilin Cancer Hospital

Jilin, Changchun, China

Location

Sun Yat-sen University Cancer Prevention Center

Guangzhou, Guangdong, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, China

Location

Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences

Shenzhen, Guangdong, 518000, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Shandong Cancer Hospital

Jinan, Shandong, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

Run Run Shaw Hospital Affiliated to Medical College of Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• BINGHE XU, PhD

  Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 9, 2019
• Study Start: October 11, 2019
• Primary Completion: May 20, 2024
• Study Completion: August 12, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)