First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT02937116 |
Recruitment Status :
Completed
First Posted : October 18, 2016
Results First Posted : February 21, 2021
Last Update Posted : October 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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Cancer, Solid Tumor | Drug: IBI308 Drug: IBI308\Cisplatinum\Pemetrexed Drug: IBI308\cisplatin\gemcitabine Drug: IBI308\oxaliplatin\capecitabine Drug: IBI308\etoposide\cisplatin Drug: IBI308\irinotecan\5-FU | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 233 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors |
Actual Study Start Date : | October 19, 2016 |
Actual Primary Completion Date : | September 30, 2020 |
Actual Study Completion Date : | September 30, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Phase 1a
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 |
Drug: IBI308 |
Experimental: Phase 1b Cohort A
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 |
Drug: IBI308 |
Experimental: Phase 1b Cohort B
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 |
Drug: IBI308 |
Experimental: Phase 1b Cohort C
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 |
Drug: IBI308 |
Experimental: Phase 1b Cohort D
Participants will receive IBI308 200mg in combination with cisplatin 75mg/m2 and pemetrexed 500mg/m2 intravenously every 3 weeks for upto 4 cycles, and those who haven't progressed will receive maintenance treatment of IBI308 200mg in combination with pemetrexed 500mg/m2 intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308/Cisplatinum/Pemetrexed |
Drug: IBI308\Cisplatinum\Pemetrexed |
Experimental: Phase 1b Cohort E
Participants will receive IBI308 200mg and cisplatin 75mg/m2 intravenously every 3 weeks in combination with gemcitabine 1250mg/m2 intravenously day 1 and 8 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\gemcitabine\cisplatin |
Drug: IBI308\cisplatin\gemcitabine |
Experimental: Phase 1b Cohort F
Participants will receive IBI308 200mg and oxaliplatin 130mg/m2 intravenously every 3 weeks in combination with capecitabine 1000mg/m2 orally day 1 to 14 of every 3 weeks for upto 6 cycles, and those those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\oxaliplatin\capecitabine |
Drug: IBI308\oxaliplatin\capecitabine |
Experimental: Phase 1b Cohort G
Participants will receive IBI308 200mg in combination with cisplatin 75mg/m2 intravenously and etoposide 100mg/m2 intravenously day 1 to 3 of every 3 weeks for upto 6 cycles. Those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\etoposide\cisplatin |
Drug: IBI308\etoposide\cisplatin |
Experimental: Phase 1b Cohort H
Participants will receive IBI308 200mg in combination with irinotecan 125mg/m2 intravenously day 1and 8 and 5-FU 1000mg/m2 intravenously day 1 to 3 of every 3 weeks for upto 6 cycles.Those who haven't progressed will receive maintenance treatment of IBI308 200mg intravenously every 3 weeks until disease progression or unacceptable toxicity or withdrawal of informed consent or up to 24 months of treatment. Drug: IBI308\irinotecan\5-FU |
Drug: IBI308\irinotecan\5-FU |
- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 28 days in Cycle 1 ]
- Number of All Study Participants Who Demonstrate a Tumor Response [ Time Frame: Through out the study (up to 2 years) ]
- Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator [ Time Frame: Through out the study (up to 2 years) ]ORR was defined as the percentage of participants in the analysis population who had achieved BOR of CR or PR according to RECIST 1.1.
- PFS According to RECIST 1.1 as Assessed by Investigator [ Time Frame: Through out the study (up to 2 years) ]
- DOR According to RECIST 1.1 as Assessed by Investigator [ Time Frame: Through out the study (up to 2 years) ]
- TTR According to RECIST 1.1 as Assessed by Investigator [ Time Frame: Through out the study (up to 2 years) ]
- OS for Participants [ Time Frame: Through out the study ]
- Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t) [ Time Frame: Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29 ]
- Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants [ Time Frame: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 ]
- Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants [ Time Frame: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 ]
- The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration [ Time Frame: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 ]
- Volume of Distribution of IBI308 in Plasma After Single Dose Administration [ Time Frame: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 ]
- Clearance of IBI308 in Plasma After Single Dose Administration [ Time Frame: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937116
China | |
The fifth medical center of the PLA general hospital | |
Beijing, China |
Documents provided by Innovent Biologics (Suzhou) Co. Ltd.:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Innovent Biologics (Suzhou) Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT02937116 |
Other Study ID Numbers: |
CIBI308A101 |
First Posted: | October 18, 2016 Key Record Dates |
Results First Posted: | February 21, 2021 |
Last Update Posted: | October 14, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Neoplasms Gemcitabine Cisplatin Capecitabine Oxaliplatin Irinotecan Etoposide Pemetrexed Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |