Advanced Lung Cancer
Conditions
Brief summary
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
Interventions
BIOLOGICALIBI939
IBI939 injection
BIOLOGICALSintilimab
Sintilimab injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed the Informed Consent Form; 2. Male or female ≥ 18 and≤75 years of age; 3. Life expectancy ≥ 12 weeks; 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1 5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements. 6. Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer
Exclusion criteria
1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine; 2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug; 3. Received any investigational agent within 4 weeks prior to the first dose of study drug; 4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose; 5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | 3 months |
| Recommended Phase II Dose(RP2D) | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough concentration (Cmin) | 24 hours | — |
| Clearance (CL) | 24 hours | — |
| Volume of distribution (V) | 24 hours | — |
| Objective response rate(ORR) | 6 months | Proportion of subjects with complete response (CR) or partial response (PR). |
| Area under the plasma concentration-time curve (AUC) | 24 hours | — |
| Time to Objective Response (TTR) | 6 months | Time from randomization to first objective tumor response (CR or PR). |
| Duration of Response (DoR) | 6 months | The time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death. |
| Progression-free survival(PFS) | 6 months | The time from randomization to the first occurrence of objective disease progression or death |
| Half-life (t1/2) | 24 hours | — |
| Disease Control Rate(DCR) | 6 months | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). |
| Maximum concentration (Cmax) | 24 hours | — |
Countries
China
Outcome results
None listed