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JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors

NCT04280341 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-08-25

No results posted yet for this study

Summary

This is a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in Treatment of HER2-Positive Advanced Malignant Solid Tumors.

Conditions

  • HER2-Positive Solid Tumors

Interventions

BIOLOGICAL

RC48-ADC in combinaton with JS001

The study has 2 parts which include dose escalation phase and dose extension phase. Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with HER2-Positive Advanced Malignant Solid Tumors sequentially at escalating doses of 2.0mg/kg and 2.5mg/kg to RC48-ADC and JS001 is fixed dose of 3.0mg/mg

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    collaborator INDUSTRY

  • Peking University

    lead OTHER

Principal Investigators

  • Lin Shen, professor · Peking University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04280341 on ClinicalTrials.gov