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Ib/II Phase Study of SHR-A1811 Injection in HER2 Positive Breast Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05353361
Collaborator
(none)
402
Enrollment
4
Arms
43.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the safety, tolerability and efficacy of SHR-A1811 combined with pyrrolidone or patrozumab or SHR-1316 or albumin paclitaxel in patients with HER2 positive non resectable or metastatic breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a multi center, open, dose exploration and efficacy expansion phase Ib / II study. The first stage is the dose exploration stage, which adopts the 3 + 3 way to climb the slope; The second stage is the curative effect expansion stage, which is divided into random groups.This study is a multi center, open, dose exploration and efficacy expansion phase Ib / II study. The first stage is the dose exploration stage, which adopts the 3 + 3 way to climb the slope; The second stage is the curative effect expansion stage, which is divided into random groups.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Multicenter Ib/II Phase Study of SHR-A1811 Plus Pyrrodinib or Ptutuzumab or SHR-1316 or Albumin Paclitaxel in the Treatment of HER2 Positive Non Resectable or Metastatic Breast Cancer
Anticipated Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-A1811combined pyrroltinib

Drug: SHR-A1811：Pyrroltinib
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrroltinib：Tablet, 160mg / tablet, 80mg / tablet, oral
Experimental: SHR-A1811Combined pertuzumab

Drug: SHR-A1811；Pertuzumab
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip
Experimental: SHR-A1811Combined SHR-1316

Drug: SHR-A1811；SHR-1316
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip SHR-1316：Injection, 12ml: 0.6g/bottle, intravenous drip
Experimental: SHR-A1811Combined Albumin paclitaxel

Drug: SHR-A1811；Albumin paclitaxel
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip

Outcome Measures

Primary Outcome Measures

  1. DLT（Phase I (dose exploration phase) main study endpoint） [21 days after the first administration of each subject]

  2. AE（Phase I (dose exploration phase) main study endpoint） [Two years after the last subject was enrolled in the group]

  3. Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) main study endpoint） [Two years after the last subject was enrolled in the group]

  4. Objective response rate（The main end points of the second stage (efficacy expansion stage)） [Two years after the last subject was enrolled in the group]

Secondary Outcome Measures

  1. Toxin binding antibody to shr-a1811（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  2. Total antibody to shr-a1811（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  3. Plasma concentration of free toxin shr169265（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  4. Plasma concentration of pyrroltinib（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  5. Plasma concentration of SHR-1316（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  6. Anti shr-a1811 antibody positive（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  7. The positive status of neutralizing antibody against shr-a1811（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  8. Anti shr-1316 antibody positive（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  9. The positive status of neutralizing antibody against shr-1316（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  10. Objective Response Rate（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  11. Duration of response（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  12. Progression Free Survival（Phase I secondary endpoint） [Two years after the last subject was enrolled in the group]

  13. AE（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  14. Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  15. Toxin binding antibody to shr-a1811（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  16. Total antibody to shr-a1811（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  17. Plasma concentration of free toxin shr169265（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  18. Plasma concentration of pyrroltinib（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  19. Plasma concentration of SHR-1316（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  20. Anti shr-a1811 antibody positive（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  21. The positive status of neutralizing antibody against shr-a1811（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  22. Anti shr-1316 antibody positive（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  23. The positive status of neutralizing antibody against shr-1316（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  24. Duration of response（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

  25. Progression Free Survival（Phase II secondary study endpoint） [Two years after the last subject was enrolled in the group]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Women aged 18 to 75 (inclusive)

  2. HER2 positive (IHC3+ or ISH+) confirmed by histology or cytology is not resectable or metastatic breast cancer.

  3. ECoG score is 0 or 1

  4. Expected survival ≥ 12 weeks

  5. According to RECIST v1 1 standard at least one measurable lesion。

  6. Good level of organ function

  7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

  1. Other malignant tumors in the past 5 years

  2. Active central nervous system metastasis without surgery or radiotherapy

  3. There is uncontrollable third space effusion

  4. Receive other anti-tumor treatment within 4 weeks before the first

  5. medicationImmunosuppressant or systemic hormone therapy was used within 2 weeks before the first medication

  6. Any active autoimmune disease or history of autoimmune disease

  7. History of immune deficiency

  8. Clinically significant cardiovascular diseases

  9. Clinically significant history of lung disease

  10. The toxicity caused by previous anti-tumor treatment has not recovered to ≤ grade I

  11. There is a tendency of hereditary or acquired bleeding and thrombosis

  12. Active hepatitis and liver cirrhosis

  13. There are other serious physical or mental diseases or laboratory abnormalities

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05353361
Other Study ID Numbers:
  • SHR-A1811-II-202
First Posted:
Apr 29, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Paclitaxel
Pertuzumab

Study Results

No Results Posted as of Apr 29, 2022