Clinical trial NCT06883630: A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC
Official title: A Phase Ib, Multi-Cohort, Open-Label, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of RC148 Injection as Monotherapy or Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of RC148 injection as a single agent or in combination for the treatment of locally advanced or metastatic non-small cell lung cancer

Detailed description: Primary objective: to evaluate the efficacy of RC148 injection as monotherapy or combination therapy in patients locally advanced or metastatic non-small cell lung cancer;

Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate in the study and signed the ICF;
2. Be willing to and able to act on the trial and the follow up procedures;
3. Male or female, aged 18-80 years;
4. Expected survival ≥ 3 months;
5. ECOG PS score 0 or 1;
6. All participants to be enrolled in cohorts 1-5 must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced or metastatic NSCLC (stage IIIB//IIIC/IV according to the 8th edition of UICC/AJCC) and not amendable to curative surgery or radiation as assessed by investigator.

Exclusion Criteria:

1. Histopathologically or cytologically confirmed small cell lung cancer;
2. Received major surgeries and still in recovery within 28 days before the first dose;
3. Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study (except for COVID-19 vaccine);
4. Received immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor treatment within 28 days prior to the first dose, or experienced prior permanent immunotherapy discontinuation due to immunotoxicity;
5. Participated in other clinical trials and received other investigational anti-tumor therapy within 28 days prior to the first dose;
6. Poor compliance and unable to complete the study procedures as assessed by investigator;
7. Have any other medical conditions, abnormal physical examinations or laboratory examinations that would be suspected interfere with participation or evaluation of the trial or increase the risk to the participant, in view of the investigator.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: 24 months
measure: Duration of Response (DOR)
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: Number of participants with adverse events (AEs)
timeFrame: 24 months
measure: Incidence of RC148 anti-drug antibody (ADA)
timeFrame: 24 months
measure: Maximum observed concentration (Cmax) of RC148
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital of Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical University
state: Guangdong
city: Foshan
country: China
facility: The First People's Hospital of Shunde
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Gulin
country: China
facility: The Second Affiliated Hospital of Guilin Medical College
state: Guangxi
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Hanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
city: Zhengzhou
country: China
facility: Henan cancer hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University Of Science And Technologe
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Sun Yat-sen University
name: li zhang
role: STUDY_DIRECTOR
References: