Trial · NCT02937116
First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
NCT02937116, Phase 1, Completed, Innovent Biologics (Suzhou) Co. Ltd.; results first posted 2021-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors. Trials, record NCT02937116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02937116
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
- NCT number
- NCT02937116
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 233 participants, actual
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Conditions
- Cancer, Solid Tumor
- Interventions
- IBI308, IBI308\Cisplatinum\Pemetrexed, IBI308\cisplatin\gemcitabine, IBI308\oxaliplatin\capecitabine, IBI308\etoposide\cisplatin, IBI308\irinotecan\5-FU
- First posted
- 2016-10-18
- Last updated
- 2022-10-14
- Results first posted
- 2021-02-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Up to 28 days in Cycle 1 | |
| Primary | Number of All Study Participants Who Demonstrate a Tumor Response | Through out the study (up to 2 years) | |
| Primary | Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator | 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. |
| Secondary | PFS According to RECIST 1.1 as Assessed by Investigator | Through out the study (up to 2 years) | |
| Secondary | DOR According to RECIST 1.1 as Assessed by Investigator | Through out the study (up to 2 years) | |
| Secondary | TTR According to RECIST 1.1 as Assessed by Investigator | Through out the study (up to 2 years) | |
| Secondary | OS for Participants | Through out the study | |
| Secondary | Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t) | Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29 | |
| Secondary | Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants | Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 | |
| Secondary | Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants | Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Up to 28 days in Cycle 1 | 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. | Participants | NUMBER |
| PRIMARY | Number of All Study Participants Who Demonstrate a Tumor Response | Through out the study (up to 2 years) | Participants | NUMBER | |
| PRIMARY | Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator | Through out the study (up to 2 years) | 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. | percentage of participants | NUMBER |
| SECONDARY | PFS According to RECIST 1.1 as Assessed by Investigator | Through out the study (up to 2 years) | 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. | Days | MEDIAN |
| SECONDARY | DOR According to RECIST 1.1 as Assessed by Investigator | Through out the study (up to 2 years) | 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. | Days | MEDIAN |
| SECONDARY | TTR According to RECIST 1.1 as Assessed by Investigator | Through out the study (up to 2 years) | 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. | Days | MEDIAN |
| SECONDARY | OS for Participants | Through out the study | 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. | Days | MEDIAN |
| SECONDARY | Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t) | Cycle 1: pre-dose, post-dose at 0, 1, and 6 hours, and Days 2, 3, 8, 15, and 22, and 29 | All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC 0-t data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis.. | h*ug/ml | GEOMETRIC_MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants | Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 | All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available Cmax data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis. | ug/ml | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants | Cycle 1: pre-dose, post-dose at 0, 1, 6 hours, and Days 2, 3, 8, 15, and 22, and 29 | All participants in Parts A1 to A4 receiving a single dose of drug during Cycle 1 (28 days) and having available Tmax data. Per protocol, participants in cohort A to H were not included in the escalating dose PK analysis. | hours | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 0 | Participants | ||
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 0 | Participants | ||
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 0 | Participants | ||
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 0 | Participants | ||
| Number of All Study Participants Who Demonstrate a Tumor Response | Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 0 | Participants | ||
| Number of All Study Participants Who Demonstrate a Tumor Response | Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 1 | Participants | ||
| Number of All Study Participants Who Demonstrate a Tumor Response | Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 0 | Participants | ||
| Number of All Study Participants Who Demonstrate a Tumor Response | Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 1 | Participants | ||
| Number of All Study Participants Who Demonstrate a Tumor Response | MEL: Sintilimab 200mg Q3W (Cohort A) | 1 | Participants | ||
| Number of All Study Participants Who Demonstrate a Tumor Response | Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 13 | Participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 3 | |
| Overall Study | STARTED | Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 3 | |
| Overall Study | STARTED | Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 3 | |
| Overall Study | STARTED | Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 3 | |
| Overall Study | STARTED | MEL: Sintilimab 200mg Q3W (Cohort A) | 22 | |
| Overall Study | STARTED | Malignant Tumor of the Digestive System or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 87 | |
| Overall Study | STARTED | NSCLC: Sintilimab 200mg Q3W (Cohort C) | 37 | |
| Overall Study | STARTED | nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 21 | |
| Overall Study | STARTED | scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 20 | |
| Overall Study | STARTED | Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 20 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events2,868
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | MEL: Sintilimab 200mg Q3W (Cohort A) | 2 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 37 | 87 | |
| other | Anaemia | Blood and lymphatic system disorders | NSCLC: Sintilimab 200mg Q3W (Cohort C) | 10 | 37 | |
| other | Anaemia | Blood and lymphatic system disorders | nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 9 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 17 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 12 | 20 |
1 to 10 of 2,868Source ClinicalTrials.gov
See all 2,868 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Solid Tumors: Sintilimab 1mg/kg Q2W (Part A1) | 0 | 3 |
| Total, all-cause mortality | Solid Tumors: Sintilimab 3mg/kg Q2W (Part A2) | 2 | 3 |
| Total, all-cause mortality | Solid Tumors: Sintilimab 10mg/kg Q2W (Part A3) | 3 | 3 |
| Total, all-cause mortality | Solid Tumors: Sintilimab 200mg/kg Q3W (Part A4) | 1 | 3 |
| Total, all-cause mortality | MEL: Sintilimab 200mg Q3W (Cohort A) | 12 | 22 |
| Total, all-cause mortality | Malignant Tumor or Neuroendocrine Tumor: Sintilimab 200mg Q3W (Cohort B) | 57 | 87 |
| Total, all-cause mortality | NSCLC: Sintilimab 200mg Q3W (Cohort C) | 25 | 37 |
| Total, all-cause mortality | nsNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort D) | 9 | 21 |
| Total, all-cause mortality | scNSCLC: Sintilimab 200mg Q3W + Chemotherapy (Cohort E) | 8 | 20 |
| Total, all-cause mortality | Gastric or Gastroesophageal Junction Adenocarcinoma: Sintilimab 200mg Q3W + Chemotherapy (Cohort F) | 3 | 20 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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