RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC

NCT05821933 | Recruiting Phase 1

• 1 other identifier: RC108-C003
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

an open, single-arm, multicenter phase Ib/II study

Conditions

NSCLC

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

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

  up to 24 months

• Dose limiting toxicity (DLT)

  To observe the durability and safety of RC108 plus Furmonertinib or plus Furmonertinib and Toripalimab in patients with advanced after single and multiple administration, observe the dose limiting toxicity (DLT)and the reversibility of toxicity

  21-days

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  up to 24 months

• Duration of Response (DOR)

  up to 24 months

• Disease control rate (DCR)

  up to 24 months

• Overall Survival(OS)

  up to 24 months

• Maximum tolerated dose (MTD)

  21-days

Study Arms (4)

cohort 1 RC108 plus Furmonertinib

EXPERIMENTAL

phaes 1: RC108 plus Furmonertinib

Drug: RC108

cohort 2 RC108 plus Furmonertinib and Toripalimab

EXPERIMENTAL

phaes 1: RC108 plus Furmonertinib and Toripalimab

Drug: RC108

cohort 3 RP2D RC108 plus Furmonertinib

EXPERIMENTAL

phaes 2: RP2D RC108 plus Furmonertinib

Drug: RC108

cohort 4 RP2D RC108 plus Furmonertinib and Toripalimab

EXPERIMENTAL

phaes 2: RP2D RC108 plus Furmonertinib and Toripalimab

Drug: RC108

Interventions

RC108 DRUG

RC108 plus Furmonertinib and/or Toripalimab

Also known as: Furmonertinib, Toripalimab

cohort 1 RC108 plus Furmonertinib; cohort 2 RC108 plus Furmonertinib and Toripalimab; cohort 3 RP2D RC108 plus Furmonertinib; cohort 4 RP2D RC108 plus Furmonertinib and Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agree to participate in the study and sign an informed consent form.
• Age between 18 and 75 years old (inclusive).
• Expected survival period of at least 12 weeks as determined by the investigator.
• ECOG performance status of 0 or 1.
• For female subjects: must be surgically sterile, postmenopausal, or willing to use a medically accepted contraceptive method (such as an intrauterine device, birth control pills, or condoms) during the study treatment period and for 6 months after the end of the study treatment. A negative pregnancy test within 7 days before study treatment initiation is required, and the subject must not be breastfeeding. For male subjects: must be surgically sterile or willing to use a medically accepted contraceptive method during the study treatment period and for 6 months after the end of the study treatment.
• Able to understand the trial requirements, willing and able to comply with trial and follow-up procedures.
• Bone marrow function:
• Hemoglobin ≥9 g/dL Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L Platelet count ≥100 × 10\^9/L
• Liver function (based on the clinical trial center's normal values):
• Serum total bilirubin ≤1.5 times the upper limit of normal (ULN) ALT and AST ≤2.5 × ULN and serum total bilirubin ≤1.5 times the ULN if there is no liver metastasis; ALT and AST ≤5 × ULN and serum total bilirubin ≤2 times the ULN if there is liver metastasis.
• Kidney function (based on the clinical trial center's normal values):
• Serum creatinine ≤1.5 × ULN, or calculated creatinine clearance (CrCl) by the Cockcroft-Gault formula ≥60 mL/min, or measured 24-hour urine CrCl ≥60 mL/min.
• Heart function:
• NYHA class \<3 Left ventricular ejection fraction (LVEF) ≥50% QTc interval ≤450 ms
• All subjects must have locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by histology or cytology.

You may not qualify if:

• Have used an investigational drug within 4 weeks prior to the start of study dosing.
• Have undergone major surgery within 4 weeks prior to the start of study dosing and have not fully recovered.
• Received a live vaccine within 4 weeks prior to the start of study dosing or are scheduled to receive any vaccine (except novel inactivated coronavirus vaccine) during the study period.
• An arterial/venous thrombotic event such as a cardiovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months prior to study dosing.
• Clinically significant QT interval prolongation or other arrhythmias or clinical states that, in the opinion of the investigator, have the potential to increase the risk of QT interval prolongation; e.g., resting state ECG QTc \&gt; 450 ms, complete left bundle branch block, third degree AV block, congenital long QT syndrome, severe hypokalemia, or ongoing medication that can cause QT interval prolongation.
• The presence of preexisting or ongoing interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonia requiring steroid medication, or those with clinical manifestations of suspected interstitial lung disease.
• The presence of clinically uncontrollable third interstitial fluid, such as pleural effusion, peritoneal effusion, or pericardial effusion that is clinically symptomatic and cannot be controlled by drainage or other means and is, in the judgment of the investigator, unenrollable.
• Suffering from systemic diseases that are not under stable control, including diabetes, hypertension, pulmonary fibrosis, acute and chronic lung disease, interstitial lung disease, cirrhosis of the liver, etc.
• Known to have a psychiatric or substance abuse disorder that may have an impact on compliance with trial requirements
• Ongoing active infection requiring systemic treatment, such as severe pneumonia, sepsis, etc.
• The presence or suspicion of active tuberculosis.
• Known presence and activity of any of the following infectious diseases: positive HIV antibody test result; positive HBsAg with positive HBV DNA (i.e., copy number ≥ 2000 copies/ml); positive HCV antibody with positive HCV RNA.
• Those who have used a strong inhibitor of cytochrome P450 3A4 (CYP3A4) within 7 days prior to the first dose or a strong inducer of CYP3A4 within 21 days
• Have any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that is inappropriate for the use of the study drug, or that will affect the interpretation of the study results, or that places the patient at high risk
• Women who are pregnant or breastfeeding or women/men who are planning to have children.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

aflutinib; toripalimab

Study Officials

• Jianmin Fang, Ph.D

  RemeGen Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Jianmin Fang, Ph.D

CONTACT

+8610-58075763; Jianminfang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 20, 2023
• Study Start: September 7, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CN (1)