Phase 1
Completed N=233
First in Human Study of IBI308 in Chinese Subjects With Advanced Solid Tumors
Cancer, Solid Tumor
Source: ClinicalTrials.gov NCT02937116 ↗
Enrolled (actual)
233
Serious AEs
23.6%
Results posted
Feb 2021
Primary outcomePrimary: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Dose-limiting Toxicities (DLTs) |
0; 0; 0; 0 | — |
| PRIMARY Number of All Study Participants Who Demonstrate a Tumor Response |
0; 1; 0; 1; 1; 13 | — |
| PRIMARY Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by Independent Review Committee by Investigator |
4.5; 14.9; 13.5; 61.9; 55.0; 85.0 | — |
| SECONDARY PFS According to RECIST 1.1 as Assessed by Investigator |
62.0; 66.0; 84.0; 377.0; 194.0; 230.0 | — |
| SECONDARY DOR According to RECIST 1.1 as Assessed by Investigator |
NA; NA; 368.0; NA; 170.5; 181.0 | — |
| SECONDARY TTR According to RECIST 1.1 as Assessed by Investigator |
63.0; 64.0; 63.0; 63.0; 62.0; 63.0 | — |
| SECONDARY OS for Participants |
518.0; 342.0; 431.0; 566.0; 461.0; NA | — |
| SECONDARY Area Under the Concentration-time Curve From Zero Time (Predose) to the Time of the Last Measurable Concentration (AUC0-t) |
4800; 12300; 39800; 10800 | — |
| SECONDARY Maximum Concentration (Cmax) of Sintilimab in Solid Tumor Participants |
21.9; 69.7; 220; 54.6 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Sintilimab in Solid Tumor Participants |
1.05; 2.07; 2.27; 1.93 | — |
| SECONDARY The Half-life (t1/2) of IBI308 in Plasma After Single Dose Administration |
17; 12.7; 12.5; 16.1 | — |
| SECONDARY Volume of Distribution of IBI308 in Plasma After Single Dose Administration |
5.02; 5.14; 5.95; 7.2 | — |
| SECONDARY Clearance of IBI308 in Plasma After Single Dose Administration |
8.53; 11.7; 13.7; 12.9 | — |
Eligibility Criteria
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) = 50 mL/min/1.73 m^2; 7) urine protein -~+, 24 hour urine 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
Data sourced from ClinicalTrials.gov (NCT02937116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.