Advanced Gastroesophageal AdenocarcinomaPhase 1/2NCT05403242
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
A Phase 1/2 study testing RC48-ADC and S-1 in people with Advanced Gastroesophageal Adenocarcinoma, run by Chinese PLA General Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastroesophageal Adenocarcinoma
- What is being tested?
- RC48-ADC and S-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesChina
- Study dates
- 20 Sep 2022to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing
Bangwei Cao
- Recruiting
Chinese PLA General Hospital
Beijing
Guanghai Dai
- Recruiting
Chinese PLA General Hospital
Beijing
Quanli Han
About this study
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
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.
- Conditions
- Advanced Gastroesophageal Adenocarcinoma
- Being tested
- RC48-ADC, S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48-ADCDrug
2.0 mg/kg, IV, d1, every 2 weeks; or 2.5 mg/kg, IV, d1, every 2 weeks
S-1Drug
40-60 mg, bid po, d1-10, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| RC48-ADC Combined With S-1 | Experimental | Not described Receives: Drug: RC48-ADC; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxity
Measured: through study completion, an average of 1 year
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.
Measured: 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 outcomes (4)
PFS(progression-free survival)
Time from randomness to the first occurrence of disease progression or death from any cause.
Measured: 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
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
Measured: 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
OS(Overall Survival)
Time from randomization to death from any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 24 months
AE(Adverse Event)
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start20 Sep 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403242
- Sponsor's protocol ID
- S2022-132-01
- Status last verified
- Jan 2024
- First submitted
- 6 May 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05403242
- Acronym / sponsor ID
- S2022-132-01
- Conditions
- Advanced Gastroesophageal Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48-ADC Combined With S-1 | Experimental | Drug: RC48-ADC, Drug: S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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-;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC48-ADC2.0 mg/kg, IV, d1, every 2 weeks; or 2.5 mg/kg, IV, d1, every 2 weeks | Drug | RC48-ADC Combined With S-1 |
| S-140-60 mg, bid po, d1-10, every 2 weeks | Drug | RC48-ADC Combined With S-1 |
Primary outcome
dose-limiting toxity
Time frame: through study completion, an average of 1 year
ORR（Objective Response Rate）
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
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.
4 secondary outcomes
PFS(progression-free survival)
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
DOR(Duration of Response )
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
OS(Overall Survival)
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months
AE(Adverse Event)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RC48-ADC and S-1 in people with Advanced Gastroesophageal Adenocarcinoma, run by Chinese PLA General Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru Jia (13811721720, ashleyjr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxity (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.