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RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

Primary Purpose

Advanced Gastroesophageal Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
RC48-ADC
S-1
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastroesophageal Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • At the same time, patients voluntarily participated in the study and signed informed consent;
  • Either male or female, aged 18 or older;
  • Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination;
  • No previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
  • HER2 IHC 2+ and FISH-;
  • ECOG scores 0-1;
  • Estimated survival ≥3 months;
  • Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
  • Patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.

Exclusion Criteria:

  • Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer;
  • Known hypersensitivity to RC48-ADC;
  • HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
  • History of HIV infection;
  • History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment;
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Sites / Locations

  • Beijing Friendship HospitalRecruiting
  • Chinese PLA General HospitalRecruiting
  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RC48-ADC Combined With S-1

Arm Description

Outcomes

Primary Outcome Measures

dose-limiting toxity
ORR（Objective Response Rate）
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.

Secondary Outcome Measures

PFS(progression-free survival)
Time from randomness to the first occurrence of disease progression or death from any cause.
DOR(Duration of Response )
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
OS(Overall Survival)
Time from randomization to death from any cause
AE(Adverse Event)
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0

Full Information

First Posted
May 6, 2022
Last Updated
September 14, 2022
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05403242
Brief Title
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
Official Title
A Multicenter, Open Label，Single Arm，Phase Ib/II Study to Evaluate the Effect and Safety of RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

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 study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastroesophageal Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RC48-ADC Combined With S-1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RC48-ADC
Intervention Description
2.0 mg/kg, IV, d1, every 2 weeks; or 2.5 mg/kg, IV, d1, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
40-60 mg, bid po, d1-10, every 2 weeks
Primary Outcome Measure Information:
Title
dose-limiting toxity
Time Frame
through study completion, an average of 1 year
Title
ORR（Objective Response Rate）
Description
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.
Time Frame
Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
Secondary Outcome Measure Information:
Title
PFS(progression-free survival)
Description
Time from randomness to the first occurrence of disease progression or death from any cause.
Time Frame
Imaging tests were performed every 8 weeks (±7 days) from the first year of treatment to assess efficacy, and every 7 weeks (±7 days) after 1 year
Title
DOR(Duration of Response )
Description
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Time Frame
Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
Title
OS(Overall Survival)
Description
Time from randomization to death from any cause
Time Frame
From date of randomization until the date of death from any cause, assessed up to 24 months
Title
AE(Adverse Event)
Description
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At the same time, patients voluntarily participated in the study and signed informed consent; Either male or female, aged 18 or older; Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination; No previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment; HER2 IHC 2+ and FISH-; ECOG scores 0-1; Estimated survival ≥3 months; Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug; Patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen. Exclusion Criteria: Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer; Known hypersensitivity to RC48-ADC; HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCV antibody positive; History of HIV infection; History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment; Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru Jia
Phone
13811721720
Email
ashleyjr@163.com
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bangwei Cao
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghai Dai
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quanli Han

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

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