Cancer, Solid TumorPhase 1NCT02937116

First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors

A Phase 1 study testing IBI308, IBI308\Cisplatinum\Pemetrexed and IBI308\cisplatin\gemcitabine in people with Cancer, Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cancer, Solid Tumor
What is being tested?: IBI308, IBI308\Cisplatinum\Pemetrexed and IBI308\cisplatin\gemcitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 233 participants
Where: 1 siteChina
Study dates: 19 Oct 2016to 30 Sep 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

China1 site

The fifth medical center of the PLA general hospital
Beijing

Other trials in China

About this study

Official title: An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors

Read the 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.

Conditions: Cancer, Solid Tumor
Being tested: IBI308, IBI308\Cisplatinum\Pemetrexed, IBI308\cisplatin\gemcitabine, IBI308\oxaliplatin\capecitabine, IBI308\etoposide\cisplatin
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IBI308Drug
IBI308\Cisplatinum\PemetrexedDrug
IBI308\cisplatin\gemcitabineDrug
IBI308\oxaliplatin\capecitabineDrug
IBI308\etoposide\cisplatinDrug
IBI308\irinotecan\5-FUDrug

Study groups in NCT02937116
Study group	Role	What they receive
Phase 1a	Experimental	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 Receives: Drug: IBI308
Phase 1b Cohort A	Experimental	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 Receives: Drug: IBI308
Phase 1b Cohort B	Experimental	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 Receives: Drug: IBI308
Phase 1b Cohort C	Experimental	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 Receives: Drug: IBI308
Phase 1b Cohort D	Experimental	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 Receives: Drug: IBI308\Cisplatinum\Pemetrexed
Phase 1b Cohort E	Experimental	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 Receives: Drug: IBI308\cisplatin\gemcitabine
Phase 1b Cohort F	Experimental	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 Receives: Drug: IBI308\oxaliplatin\capecitabine
Phase 1b Cohort G	Experimental	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 Receives: Drug: IBI308\etoposide\cisplatin
Phase 1b Cohort H	Experimental	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 Receives: Drug: IBI308\irinotecan\5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Measured: Up to 28 days in Cycle 1
Number of All Study Participants Who Demonstrate a Tumor Response
Measured: 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
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.
Measured: Through out the study (up to 2 years)

Secondary outcomes (10)

PFS According to RECIST 1.1 as Assessed by Investigator
Measured: Through out the study (up to 2 years)
DOR According to RECIST 1.1 as Assessed by Investigator
Measured: Through out the study (up to 2 years)
TTR According to RECIST 1.1 as Assessed by Investigator
Measured: Through out the study (up to 2 years)
OS for Participants
Measured: Through out the study
Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 201630 Sep 2020

First posted18 Oct 2016 (estimated)
Study start19 Oct 2016
Primary completion30 Sep 2020
Study completion30 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Cancer, Solid TumorStudies of the same condition, open and under way.
More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02937116
Sponsor's protocol ID: CIBI308A101
Status last verified: Sep 2022
First submitted: 8 Oct 2016
Last updated: 14 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Jiang 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.
PubMed 32795349
Jiang 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.
PubMed 33070260
Wei 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.
PubMed 35747712
Jia 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.
PubMed 35647908
Jiang 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.
PubMed 34659886
Zhang 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.
PubMed 32372672

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cancer, Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter Study of IBI308 in Subjects With Selected Advanced Solid Tumors
ClinicalTrials.gov ID: NCT02937116
Acronym / sponsor ID: CIBI308A101
Conditions: Cancer, Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 19 Oct 2016 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 18 Oct 2016 (estimated)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Phase 1a	Experimental	Drug: IBI308Participants 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
Phase 1b Cohort A	Experimental	Drug: IBI308Participants 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
Phase 1b Cohort B	Experimental	Drug: IBI308Participants 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
Phase 1b Cohort C	Experimental	Drug: IBI308Participants 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
Phase 1b Cohort D	Experimental	Drug: IBI308\Cisplatinum\PemetrexedParticipants 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
Phase 1b Cohort E	Experimental	Drug: IBI308\cisplatin\gemcitabineParticipants 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
Phase 1b Cohort F	Experimental	Drug: IBI308\oxaliplatin\capecitabineParticipants 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
Phase 1b Cohort G	Experimental	Drug: IBI308\etoposide\cisplatinParticipants 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
Phase 1b Cohort H	Experimental	Drug: IBI308\irinotecan\5-FUParticipants 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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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
At least 1 measurable site of disease per RECIST v1.1

Key exclusion criteria (13 listed)

Prior treatment of any antibody of PD-1 or PD-L1
Prior treatment of ipilimumab, unless all the following requirements are met:
HIV infection
Active HBV or HCV infection
Uncontrolled complication including but not limited to :

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IBI308	Drug	Phase 1a, Phase 1b Cohort A, Phase 1b Cohort B, Phase 1b Cohort C
IBI308\Cisplatinum\Pemetrexed	Drug	Phase 1b Cohort D
IBI308\cisplatin\gemcitabine	Drug	Phase 1b Cohort E
IBI308\oxaliplatin\capecitabine	Drug	Phase 1b Cohort F
IBI308\etoposide\cisplatin	Drug	Phase 1b Cohort G
IBI308\irinotecan\5-FU	Drug	Phase 1b Cohort H

Primary outcome

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.

10 secondary outcomes

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

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)	3	0
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)	3	0
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)	3	0
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)	3	0
MEL: Sintilimab 200mg Q3W (Cohort A)	22	0
Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)	87	0
NSCLC: Sintilimab 200mg Q3W (Cohort C)	37	0
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)	21	0
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)	20	0
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)	20	0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)	7	0
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)	7	0

Primary outcome: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

Time frame: Up to 28 days in Cycle 1. Number. Unit: Participants

Measure	Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) n = 3	Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) n = 3	Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) n = 3	Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) n = 3	MEL: Sintilimab 200mg Q3W (Cohort A) n = 0	Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) n = 0	NSCLC: Sintilimab 200mg Q3W (Cohort C) n = 0	nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) n = 0	scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) n = 0	Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) n = 0	Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) n = 0	Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) n = 0
Value	0	0	0	0	–	–	–	–	–	–	–	–

Population analysed: All participants in Parts A1 to A4 who received ≥1 dose of study treatment and either 1) had a DLT in Cycle 1 or 2) received ≥90% of the prescribed dose of Sintilimab in Cycle 1 and completed all safety evaluations ≥28 days after the first administration of Sintilimab without experiencing DLT. Per protocol, cohort A to H were not analyzed.

Primary outcome: Number of All Study Participants Who Demonstrate a Tumor Response

Time frame: Through out the study (up to 2 years). Number. Unit: Participants

Measure	Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) n = 3	Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) n = 3	Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) n = 3	Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) n = 3	MEL: Sintilimab 200mg Q3W (Cohort A) n = 22	Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) n = 87	NSCLC: Sintilimab 200mg Q3W (Cohort C) n = 37	nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) n = 21	scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) n = 20	Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) n = 20	Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) n = 7	Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) n = 7
Value	0	1	0	1	1	13	5	13	11	17	3	1

Primary outcome: 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). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) n = 0	Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) n = 0	Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) n = 0	Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) n = 0	MEL: Sintilimab 200mg Q3W (Cohort A) n = 22	Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) n = 87	NSCLC: Sintilimab 200mg Q3W (Cohort C) n = 37	nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) n = 21	scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) n = 20	Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) n = 20	Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G) n = 7	Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H) n = 7
Value	–	–	–	–	4.5 (0.1 to 22.8)	14.9 (8.2 to 24.2)	13.5 (4.5 to 28.8)	61.9 (38.4 to 81.9)	55.0 (31.5 to 76.9)	85.0 (62.1 to 96.8)	42.9 (9.9 to 81.6)	14.3 (0.4 to 57.9)

Population analysed: Participants from cohort A to H that received ≥1 dose of study treatment. Per protocol, Part A1 to A4 (dose-escalation) was not analyzed for efficacy.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 90 days (through Final Database cut-off date of 30-Oct-2017) for Phase Ia (Part A1 to A4); Up to approximately 90 days (through Final Database cut-off date of 17-Apr-2019) for Phase Ib (Cohort A to F); Up to approximately 90 days (through Final Database cut-off date of 30-Sep-2019) for Phase Ib (Cohort G to H);. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2)	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3)	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4)	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
MEL: Sintilimab 200mg Q3W (Cohort A)	0 of 22 (0%)	18 of 22 (81.8%)	12 of 22
Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B)	18 of 87 (20.7%)	82 of 87 (94.3%)	57 of 87
NSCLC: Sintilimab 200mg Q3W (Cohort C)	11 of 37 (29.7%)	35 of 37 (94.6%)	25 of 37
nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D)	3 of 21 (14.3%)	19 of 21 (90.5%)	9 of 21
scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E)	9 of 20 (45%)	20 of 20 (100%)	8 of 20
Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F)	6 of 20 (30%)	20 of 20 (100%)	3 of 20
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort G)	2 of 7 (28.6%)	7 of 7 (100%)	0 of 7
Neuroendocrine Tumors: Sintilimab 200mg Q3W + Chemotherapy (Cohort H)	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32795349Jiang 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.
Results publication: PubMed 33070260Jiang 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.
Derived from this study: PubMed 35747712Wei 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.
Derived from this study: PubMed 35647908Jia 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.
Derived from this study: PubMed 34659886Jiang 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.
Derived from this study: PubMed 32372672Zhang 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.
Abstract for Cohort E on Jtho.2018Link provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI308, IBI308\Cisplatinum\Pemetrexed and IBI308\cisplatin\gemcitabine in people with Cancer, Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-limiting Toxicities (DLTs) (time frame: Up to 28 days in Cycle 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02937116, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.