First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
Condition: Cancer, Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and efficacy of IBI308
      monotherapy or in combination with chemotherapy in patients with certain types of advanced
      solid tumors. Another purpose is to determine the pharmacokinetics, pharmacodynamics and
      immunogenicity of IBI308.
    

Detailed description: 
      This is a study which consists of phase 1a study (dose escalation stage) and phase 1b study
      (expansion stage). Phase 1a study will adopt the classical 3+3 dose escalation design,
      exploring safety and tolerance of 4 dose cohorts (1mg/kg, 3mg/kg, 200mg and 10mg/kg) and
      determining the recommended dose for phase 1b study. Phase 1b is expansion study of 8 cohorts
      which will evaluate anti-tumor efficacy and safety of eight IBI308 monotherapy or in
      combination with chemotherapy. Cohort A is IBI308 monotherapy for advanced melanoma. Cohort B
      is IBI308 monotherapy for advanced digestive system carcinoma or neuroendocrine neoplasm
      after failure or intolerance of first line standard therapy. Cohort C is IBI308 monotherapy
      for advanced non-small cell lung cancer (NSCLC) after failure or intolerance of first line
      standard therapy. Cohort D is IBI308 in combination with cisplatin and pemetrexed for
      treatment naïve locally advanced, recurrent or metastatic non-squamous NSCLC. Cohort E is
      IBI308 in combination with gemcitabine and cisplatin for treatment-naïve locally advanced,
      recurrent or metastatic squamous NSCLC. Cohort F is IBI308 in combination with oxaliplatin
      and capecitabine for treatment naïve locally advanced gastric or gastroesophageal junction
      adenocarcinoma. Cohort G is IBI308 in combination with etoposide and cisplatin for treatment
      naïve locally advanced, recurrent or metastatic high grade(G3) neuroendocrine tumor. Cohort H
      is IBI308 in combination with irinotecan and 5-FU for advanced high grade(G3) neuroendocrine
      tumor after failure of first line standard therapy. Phase 1a and 1b consist of screening
      period (28 days before enrollment), treatment period and follow up period (every 3 months
      until death or the end of study). In phase 1a, dose limiting toxicity (DLT) will be recorded
      for up to 28 days after the 1st dose of IBI308. Efficacy will be evaluated by RECIST v1.1.
      Adverse events will be monitored throughout the study. Further exploration of
      pharmacokinetic/pharmacodynamics and immunogenicity information will be assessed throughout
      the trial.
    

Intervention name(s): IBI308; IBI308\Cisplatinum\Pemetrexed; IBI308\cisplatin\gemcitabine; IBI308\oxaliplatin\capecitabine; IBI308\etoposide\cisplatin; IBI308\irinotecan\5-FU
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cisplatin; Gemcitabine; Capecitabine; Oxaliplatin; Irinotecan; Etoposide; Pemetrexed
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment