A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC

NCT06883630
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
121
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Lead sponsor
RemeGen Co., Ltd.
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Start date
2025-03-13
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Number of sites
24
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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
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Short title
A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC
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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.
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-07-31
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First posted
2025-03-19
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Registry last updated
2026-03-05
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Primary completion date
2026-08-31
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Start date
2025-03-13
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Actual participants
121
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Participants
121
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
24
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Registry sponsor category
Industry
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Lead sponsor
RemeGen Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06883630
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ClinicalTrials.gov ID
NCT06883630
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Participants
Sources for study design
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  1. Objective Response Rate (ORR)

    Timeframe: 24 months

    Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.

  1. Disease Control Rate (DCR)

    Timeframe: 24 months

    Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.

  2. Duration of Response (DOR)

    Timeframe: 24 months

    Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.

  3. Progression-free survival (PFS)

    Timeframe: 24 months

    Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.

  4. Overall survival (OS)

    Timeframe: 24 months

    Tumor assessment will be performed until radiographic disease progression, initiation of new anticancer therapy, withdrawal of consent, death, loss to follow-up, or other end of study criterion is met, whichever is earlier.

  5. Number of participants with adverse events (AEs)

    Timeframe: 24 months

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  6. Incidence of RC148 anti-drug antibody (ADA)

    Timeframe: 24 months

    Serum samples will be collected from participants for ADA analysis of RC148. The blood sampling time points and time windows are described in protocol

  7. Maximum observed concentration (Cmax) of RC148

    Timeframe: 24 months

    Serum concentrations of RC148 in individual subjects at different time points after RC148 administration

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
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  • Beijing Tiantan Hospital of Capital Medical UniversityBeijing, China
  • Peking University Cancer HospitalBeijing, China
  • Shunde Hospital of Southern Medical UniversityFoshan, China
  • The First People's Hospital of ShundeFoshan, China
  • Sun Yat-sen University Cancer CenterGuangzhou, China
  • The First affiliated Hospital of Guangzhou Medical UniversityGuangzhou, China
  • Jiangmen Central HospitalJiangmen, China
  • The Second Affiliated Hospital of Guilin Medical CollegeGulin, China
  • Affiliated Cancer Hospital of Guangxi Medical UniversityNanning, China
  • Harbin Medical University Cancer HospitalHarbin, China
  • Nanyang Second General HospitalHanyang, China
  • The First Affiliated Hospital of Xinxiang Medical CollegeXinxiang, China
  • Henan cancer hospitalZhengzhou, China
  • Union Hospital Tongji Medical College Huazhong University Of Science And TechnologeWuhan, China
  • Hunan Cancer HospitalChangsha, China
  • The Affiliated Hospital of Xuzhou Medical UniversityXuzhou, China
  • Shengjing Hospital of China Medical UniversityShenyang, China
  • Binzhou Medical University HospitalBinzhou, China
  • Jinan Central HospitalJinan, China
  • Linyi Cancer HospitalLinyi, China
  • Tianjin Medical University Cancer Institute HospitalTianjin, China
  • Yunnan Cancer HospitalKunming, China
  • Zhejiang Cancer HospitalHangzhou, China
  • Taizhou Hospital of Zhejiang ProvinceTaizhou, China
Sources for sites
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Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (19)