Clinical trial · Interventional
First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors
NCT02937116CI-TRIAL-00061469completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Solid Tumor | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI308 | Drug | Sintilimab | ALIAS |
| IBI308\cisplatin\gemcitabine | Drug | — | UNRESOLVED |
| IBI308\Cisplatinum\Pemetrexed | Drug | — | UNRESOLVED |
| IBI308\etoposide\cisplatin | Drug | — | UNRESOLVED |
| IBI308\irinotecan\5-FU | Drug | — | UNRESOLVED |
| IBI308\oxaliplatin\capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Phase 1a
- description
- Participants will receive IBI308 1mg/kg, 3mg/kg or 10mg/kg intravenous every 2 weeks, or 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity. Drug: IBI308
- interventionNames
- Drug: IBI308
- type
- EXPERIMENTAL
- label
- Phase 1b Cohort A
- description
- Participants will receive IBI308 200mg intravenous every 3 weeks and will be continued until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308
- interventionNames
- Drug: IBI308
- type
- EXPERIMENTAL
- label
- Phase 1b Cohort B
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1 * Adequate bone marrow, liver, and renal function defined as: 1) Absolute neutrophil count \>= 1.5\* 10\^9 cells/litre (L); 2) Platelets \>=100 x 10\^9 cells/L; 3) Hemoglobin \>= 9 gram/deciliter (g/dL); 4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 \* upper limit of normal (ULN) for participants without hepatic cell cancer and hepatic metastasis, ALT and AST \<= 5 \* ULN for participants with hepatic cell cancer or hepatic metastasis; 5) Total bilirubin (TBIL) \< 1.5 \* ULN for participants without hepatic cell cancer, hepatic metastasis and confirmed/suspicious Gilbert syndrome, TBIL \< 3 \* ULN for participants with hepatic cell cancer, hepatic metastasis or confirmed/suspicious Gilbert syndrome; 6) Creatinine determined by serum creatinine levels \<=1.5 \* ULN or a calculated creatinine clearance of \>= 50 mL/min/1.73 m\^2; 7) urine protein -\~+, 24 hour urine \< 1 gram for participants with urine protein ++ or above; 8) activated partial thromboplastin time and international normalized ratio \<= 1.5 \* ULN; 9) thyroid stimulating hormone and free thyroxine 4 within normal range * Tumor type * Phase 1a: advanced solid tumors after failure of standard therapy * Phase 1b Cohort A: cytologically or histologically confirmed advanced melanoma * Phase 1b Cohort B: cytologically or histologically confirmed advanced malignancies of the digestive system after failure of at least 1 line of standard therapy * Phase 1b Cohort C: cytologically or histologically confirmed advanced NSCLC without known epithelial growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement after failure of 1st line standard therapy * Phase 1b Cohort D: treatment naive cytologically or histologically confirmed inoperable locally advanced (stage IIIB) or advanced (stage IV) nsNSCLC without known EGFR mutation and ALK rearrangement, participants with disease recurrence or progression within 6 months after completion of prior platinum doublet-based chemotherapy regimen as neoadjuvant or adjuvant therapy are not eligible * Phase 1b Cohort E: Cytologically or histologically confirmed, treatment naïve locally advanced, recurrent or metastatic squamous NSCLC without known EGFR mutation and ALK rearrangement. Participants with Stage IIIB NSCLC who progressed within 6 months after completion of platinum-based chemotherapy are not eligible. * Phase 1b Cohort F: Histologically confirmed locally advanced, recurrent or metastatic gastric or esophagogastric junction adenocarcinoma without known HER2 amplification. * Phase 1b Cohort G: Cytologically or histologically confirmed, treatment naïve locally advanced, recurrent or metastatic high grade(G3) neuroendocrine tumor with Ki-67\>20%. * Phase 1b Cohort H: Cytologically or histologically confirmed advanced high grade(G3) neuroendocrine tumor with Ki-67\>20% after failure of first line standard therapy. Participants progressed within 6 months after completion of adjuvant or neoadjuvant chemotherapy are eligible. * At least 1 measurable site of disease per RECIST v1.1 Exclusion Criteria: * Prior treatment of any antibody of PD-1 or PD-L1 * Prior treatment of ipilimumab, unless all the following requirements are met: * Full resolution of ipilimumab related adverse effects (including immune related adverse effects) and no treatment for these adverse events (AEs) for at least 4 weeks prior to the time of enrollment * Minimum of 12 weeks from the first dose of ipilimumab and \>6 weeks from the last dose * No history of severe immune related adverse effects from ipilimumab (CTCAE Grade 4; CTCAE Grade 3 requiring treatment \>4 weeks) * Unequivocal PD following a dose of ipilimumab * HIV infection * Active HBV or HCV infection * Uncontrolled complication including but not limited to : * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias or congestive heart failure * History of stroke, myocardial infarction or intracranial hemorrhage within 6 months prior to the enrolment * History or risk of autoimmune disease * Known interstitial lung disease
References
Publications (6)
- RESULTJiang H, Zheng Y, Qian J, Mao C, Xu X, Li N, Xiao C, Wang H, Teng L, Zhou H, Wang S, Zhu D, Peng B, Shen L, Xu N. Safety and efficacy of sintilimab combined with oxaliplatin/capecitabine as first-line treatment in patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma in a phase Ib clinical trial. BMC Cancer. 2020 Aug 14;20(1):760. doi: 10.1186/s12885-020-07251-z. PMID 32795349
- RESULTJiang H, Zheng Y, Qian J, Mao C, Xu X, Li N, Xiao C, Wang H, Teng L, Zhou H, Wang S, Zhu D, Sun T, Yu Y, Guo W, Xu N. Efficacy and safety of sintilimab in combination with chemotherapy in previously untreated advanced or metastatic nonsquamous or squamous NSCLC: two cohorts of an open-label, phase 1b study. Cancer Immunol Immunother. 2021 Mar;70(3):857-868. doi: 10.1007/s00262-020-02738-x. Epub 2020 Oct 17. PMID 33070260
- DERIVEDWei J, Lu X, Liu Q, Fu Y, Liu S, Li L, Liu F, Fan X, Yang J, Yang Y, Zhao Y, Guan W, Liu B. Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial. Cancer Manag Res. 2022 Jun 17;14:2007-2015. doi: 10.2147/CMAR.S355687. eCollection 2022. PMID 35747712
- DERIVEDJia R, Li Y, Xu N, Jiang HP, Zhao CH, Liu RR, Shi Y, Zhang YY, Wang SY, Zhou H, Xu JM. Sintilimab in Patients with Previously Treated Metastatic Neuroendocrine Neoplasms. Oncologist. 2022 Aug 5;27(8):e625-e632. doi: 10.1093/oncolo/oyac097. PMID 35647908
- DERIVEDJiang H, Li N, Wang H, Chen Z, Zheng Y, Qian J, Mao C, Xu X, Xiao C, Zhang X, Zhou H, Wang S, Chen W, Yin X, Sun J, Peng B, Teng L, Xu N. Assessment of TMB, PD-L1, and lymphocyte to monocyte ratio as predictive potential in a phase Ib study of sintilimab in patients with advanced solid tumors. Am J Cancer Res. 2021 Sep 15;11(9):4259-4276. eCollection 2021. PMID 34659886
- DERIVEDZhang J, Wu L, Liu J, Lin M. A metastatic intrahepatic cholangiocarcinoma treated with programmed cell death 1 inhibitor: a case report and literature review. Immunotherapy. 2020 Jun;12(8):555-561. doi: 10.2217/imt-2019-0100. Epub 2020 May 6.