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A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing

Primary Purpose

Advanced Salivary Gland Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-A1811
SHR 3680 + leuprolide
SHR-A1921
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Salivary Gland Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients volunteered to participate in this study and signed informed consent; Aged ≥ 18 but ≤ 75 years, male or female; Histologically confirmed to be locally advanced or metastatic salivary gland carcinoma; Arm1: salivary gland carcinoma patients with HER-2 alteration including HER-2 positive or mutation/amplification; Arm 2: salivary gland carcinoma patients with AR-positive; Arm 3: salivary gland carcinoma patients without HER-2 alteration or AR-positive; At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress); ECOG Perfomance Status: 0~1; Estimated survival time ≥ 12 weeks; The main organs function are normal, and meet the following requirements (within 7 days before the start of study treatment): Blood routine examination(no blood transfusion within 14 days before screening, no granulocyte colony stimulating factor (G-CSF), no medication corrected):1) Hemoglobin (HB)≥ 90g / L;2) Neutrophil count (ANC) ≥ 1.5 × 109 / L;3) platelets (PLT) ≥ 80 × 109 / L; Blood biochemical tests are subject to the following criteria (no albumin is delivered 14 days prior to screening):1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST])< 2.5 × ULN; if liver metastasis, ALT and AST ≤ 5 × ULN;3) Serum creatinine (Cr) ≤ 1 × ULN or endogenous creatinine clearance > 50ml / min (Cockcroft-Gault formula); International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the range of normal controls ≤ 6 seconds; Urine protein <2+ (if urine protein ≥ 2+, 24-hour urine protein can be quantified, 24-hour urine protein quantitation <1.0g can be included); Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and volunteer to use appropriate methods during the observation period and within 8 weeks after the last study drug administration; for men, sterilization surgery should be performed, or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; Patient who are expected to have good compliance and can accept follow-up visit for the efficacy and adverse reactions according to the program requirements. Exclusion Criteria: Have other active malignancies within 5 years or at the same time. Localized tumors that have been cured, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled. Other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, etc.) were used within 28 days prior to the first use of the study drug. if the last dose of anti-tumor drug had been stopped ≥ 5 half-life can be allowed. There are clinical symptoms or diseases of the heart that are not well controlled, such as: According to the New York Heart Association (NYHA) standard, level II or higher cardiac dysfunction or echocardiography: left ventricular ejection fraction<50%; unstable angina; Myocardial infarction occurred within 1 year before the start of treatment; Clinically significant supraventricular or ventricular arrhythmia that requires treatment or intervention; corrected QT interval(QTc) > 450ms (male); QTc > 470ms (female) (Calculation of QTc interval with Fridericia formula; if the QTc is abnormal, it can be detected three times at an interval of 2 minutes, and the average value is taken); Patients with high blood pressure who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (average of BP based on ≥2 measurements), allowing the use of antihypertensive treatment to achieve the above parameters. A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction) (Only apply for Arm 2 patients); Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) those with a history of melena and hematemesis within 3 months; Abnormal coagulation function (INR>1.5×ULN,activated partial thromboplastin time>1.5×ULN), with bleeding tendency.

Sites / Locations

  • Dongmei JiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

This arm for HER2-alteration salivray gland carcinoma.

This arm for AR-postive salivray gland carcinoma.

This arm for salivray gland carcinoma without HER-2 alteration or AR-postive.

Outcomes

Primary Outcome Measures

ORR
Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.

Secondary Outcome Measures

DCR
DCR defined as the patients confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Progression-free Survival (PFS)
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival (OS)
Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Adverse events
Hematologic and non hematologic adverse event (CTCAE 5.0)

Full Information

First Posted
June 21, 2023
Last Updated
July 31, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05924256
Brief Title
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Official Title
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-center, open-label, phase 2 study to evaluate the efficacy and safety of target therapy for patients with relapsed/metastastic salivary gland carcinoma based on molecular typing.
Detailed Description
Patients with IHC HER2 2+ or 3+ will be located into arm 1 to receive anti-her2 ADC(SHR- A1811) Patients with IHC AR positive will be located into arm 2 to receive anti-androgen therapy (SHR-3680)+leuprolide Patients with HER2 negative and AR negative will be located into arm 3 to receive anti-TROP2 ADC (SHR-A1921)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Salivary Gland Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
This arm for HER2-alteration salivray gland carcinoma.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
This arm for AR-postive salivray gland carcinoma.
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
This arm for salivray gland carcinoma without HER-2 alteration or AR-postive.
Intervention Type
Drug
Intervention Name(s)
SHR-A1811
Intervention Description
SHR-A1811
Intervention Type
Drug
Intervention Name(s)
SHR 3680 + leuprolide
Intervention Description
SHR 3680 + leuprolide
Intervention Type
Drug
Intervention Name(s)
SHR-A1921
Intervention Description
SHR-A1921
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.
Time Frame
at the end of every 2 cycles(for arm1 and arm3, each cycle is 21 days, for arm2, each cycle is 28 days)
Secondary Outcome Measure Information:
Title
DCR
Description
DCR defined as the patients confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Time Frame
at the end of every 2 cycles(for arm1 and arm3, each cycle is 21 days, for arm2, each cycle is 28 days)
Title
Progression-free Survival (PFS)
Description
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
up to 2 years
Title
Overall Survival (OS)
Description
Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Time Frame
up to 2 years
Title
Adverse events
Description
Hematologic and non hematologic adverse event (CTCAE 5.0)
Time Frame
Since the signing of informed consent forms to 30 days after the last cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients volunteered to participate in this study and signed informed consent; Aged ≥ 18 but ≤ 75 years, male or female; Histologically confirmed to be locally advanced or metastatic salivary gland carcinoma; Arm1: salivary gland carcinoma patients with HER-2 alteration including HER-2 positive or mutation/amplification; Arm 2: salivary gland carcinoma patients with AR-positive; Arm 3: salivary gland carcinoma patients without HER-2 alteration or AR-positive; At least one measurable lesion (according to RECIST v1.1, long diameter of measurable lesion scanned by spiral CT should be ≥ 10 mm or short diameter of swollen lymph node should be ≥ 15 mm; according to RECIST vl.1 standards, a previously treated lesion with local treatment can be used as target lesions after clear progress); ECOG Perfomance Status: 0~1; Estimated survival time ≥ 12 weeks; The main organs function are normal, and meet the following requirements (within 7 days before the start of study treatment): Blood routine examination(no blood transfusion within 14 days before screening, no granulocyte colony stimulating factor (G-CSF), no medication corrected):1) Hemoglobin (HB)≥ 90g / L;2) Neutrophil count (ANC) ≥ 1.5 × 109 / L;3) platelets (PLT) ≥ 80 × 109 / L; Blood biochemical tests are subject to the following criteria (no albumin is delivered 14 days prior to screening):1) Serum total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanine aminotransferase (ALT), aspartate aminotransferase (AST])< 2.5 × ULN; if liver metastasis, ALT and AST ≤ 5 × ULN;3) Serum creatinine (Cr) ≤ 1 × ULN or endogenous creatinine clearance > 50ml / min (Cockcroft-Gault formula); International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the range of normal controls ≤ 6 seconds; Urine protein <2+ (if urine protein ≥ 2+, 24-hour urine protein can be quantified, 24-hour urine protein quantitation <1.0g can be included); Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and volunteer to use appropriate methods during the observation period and within 8 weeks after the last study drug administration; for men, sterilization surgery should be performed, or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; Patient who are expected to have good compliance and can accept follow-up visit for the efficacy and adverse reactions according to the program requirements. Exclusion Criteria: Have other active malignancies within 5 years or at the same time. Localized tumors that have been cured, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be enrolled. Other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, etc.) were used within 28 days prior to the first use of the study drug. if the last dose of anti-tumor drug had been stopped ≥ 5 half-life can be allowed. There are clinical symptoms or diseases of the heart that are not well controlled, such as: According to the New York Heart Association (NYHA) standard, level II or higher cardiac dysfunction or echocardiography: left ventricular ejection fraction<50%; unstable angina; Myocardial infarction occurred within 1 year before the start of treatment; Clinically significant supraventricular or ventricular arrhythmia that requires treatment or intervention; corrected QT interval(QTc) > 450ms (male); QTc > 470ms (female) (Calculation of QTc interval with Fridericia formula; if the QTc is abnormal, it can be detected three times at an interval of 2 minutes, and the average value is taken); Patients with high blood pressure who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (average of BP based on ≥2 measurements), allowing the use of antihypertensive treatment to achieve the above parameters. A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction) (Only apply for Arm 2 patients); Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) those with a history of melena and hematemesis within 3 months; Abnormal coagulation function (INR>1.5×ULN,activated partial thromboplastin time>1.5×ULN), with bleeding tendency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongmei Ji, Doctor
Phone
13564183928
Email
jidongmei2000@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongmei Ji
Phone
13564183928
Email
jidongmei2000@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongmei Ji, Doctor
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongmei Ji
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongmei Ji, Doctor
Phone
13564183928
Email
jidongmei2000@126.com
First Name & Middle Initial & Last Name & Degree
Dongmei Ji, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing

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