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

C

Chinese PLA General Hospital (301 Hospital)

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Advanced Gastroesophageal Adenocarcinoma

Treatments

Drug: RC48-ADC
Drug: S-1

Study type

Interventional

Funder types

Other

Identifiers

NCT05403242
S2022-132-01

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

RC48-ADC Combined With S-1
Experimental group
Treatment:
Drug: S-1
Drug: RC48-ADC

Trial contacts and locations

2

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Central trial contact

Ru Jia

Data sourced from clinicaltrials.gov

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