NCT03556345

Brief Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

June 1, 2018

Last Update Submit

January 12, 2022

Conditions

Gastric CancerHER2 Overexpressing Gastric Carcinoma

Keywords

RC48-ADCHER2 overexpressionGastric cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate （ORR）

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

    up to 24 months

Secondary Outcomes (2)

  • Progression Free Survival (PFS) as Assessed by investigator

    up to 24 months

  • Overall Survival(OS)

    up to 24 months

Study Arms (1)

RC48-ADC

EXPERIMENTAL

Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).

Drug: RC48-ADC

Interventions

RC48-ADCDRUG

2.5 mg/kg IV every 2 weeks

Also known as: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
RC48-ADC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary agreement to provide written informed consent.
  • Male or female, Age ≥ 18 years and ≤ 80 years.
  • Predicted survival ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
  • Adequate organ function.
  • Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
  • HER2 overexpression defined as HER2 IHC 2+ or 3+.
  • Measurable disease according to RECIST 1.1.

You may not qualify if:

  • Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
  • History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
  • History of major surgery within 4 weeks of planned start of trial treatment.
  • Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

  • Peng Z, Liu T, Wei J, Wang A, He Y, Yang L, Zhang X, Fan N, Luo S, Li Z, Gu K, Lu J, Xu J, Fan Q, Xu R, Zhang L, Li E, Sun Y, Yu G, Bai C, Liu Y, Zeng J, Ying J, Liang X, Xu N, Gao C, Shu Y, Ma D, Dai G, Li S, Deng T, Cui Y, Fang J, Ba Y, Shen L. Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single-arm phase II study. Cancer Commun (Lond). 2021 Nov;41(11):1173-1182. doi: 10.1002/cac2.12214. Epub 2021 Oct 19.

    PMID: 34665942DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 14, 2018

Study Start

July 10, 2018

Primary Completion

June 1, 2020

Study Completion

August 31, 2020

Last Updated

January 13, 2022

Record last verified: 2022-01

Locations

CN(1)