A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

NCT05745740 | Unknown Phase 1

• 1 other identifier: RC48-C021
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• maximal tolerance dose (MTD) of RC48-ADC combined with Pyrotinib

  Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.

  DLT will be evaluated on 28 days of observation period

Secondary Outcomes (5)

• Overall response rate (ORR)

  Up to approximately 3 years

• Disease control rate (DCR)

  Up to approximately 3 years

• Duration of relief (DOR)

  Up to approximately 3 years

• Progression-free survival (PFS)

  Up to approximately 3 years

• Overall survival (OS)

  Up to approximately 3 years

Study Arms (1)

RC48-ADC + Pyrotinib

EXPERIMENTAL

Drug: RC48-ADC; Drug: Pyrotinib

Interventions

RC48-ADC DRUG

RC48-ADC 1.5/2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle

Also known as: DV

RC48-ADC + Pyrotinib

Pyrotinib DRUG

Pyrotinib 400 mg by oral once a day.

RC48-ADC + Pyrotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary agreement to provide written informed consent.
• Predicted survival ≥ 12 weeks.
• According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC.
• Is willing and able to provide an adequate archival tumor tissue sample
• Has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy.
• Measurable lesion according to RECIST 1.1.
• Documented HER2 exon 20 insertion mutation.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Adequate organ function.
• For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. Male subjects: Patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study.
• Willing and able to follow trial and follow-up procedures.

You may not qualify if:

• No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.
• Patient has had previous treatment with HER2-targeted therapy prior to study participation.
• History of major surgery within 4 weeks of planned start of trial treatment.
• Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
• Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
• NYHA Class III heart failure.
• Suffering from active infection requiring systemic treatment.
• Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD.
• Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pyrotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jianmin Fang, Ph.D

CONTACT

+8610-58075763; jianminfang@hotmail.com

Na Su

CONTACT

+8610-58075763; na.su@remegen.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-03

Locations

CN (1)