Pancreatic Cancer
Conditions
Brief summary
This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.
Detailed description
This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. It is planned to enroll 201 participants, and participants will be randomized to receive IBI343 plus BSC or placebo plus BSC in a 2:1 ratio.
Interventions
DRUGIBI343
Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
DRUGPlacebo
Subjects in the control arm will receive placebo 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycle
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sign the written informed consent form (ICF) and be willing and able to comply with the visits and related procedures stipulated in the plan. 2. Histologically confirmed unresectable locally advanced, or metastatic pancreatic cancer. 3. Have received and progression after at least two systemic therapies(must including a fluorouracil-based and a gemcitabine-based therapy). 4. ECOG PS score of 0 or 2. 5. Adequate bone marrow and organ function 6. Confirmed as CLDN18.2 positive.
Exclusion criteria
1. Participation in another interventional study, except observational or post-intervention follow-up. 2. Prior treatment with topoisomerase inhibitor-based ADC. 3. Has received the last dose of an anti-cancer therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. 4. Plans to receive other anti-tumor treatments during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed) . 5. Symptomatic CNS metastasis; asymptomatic brain metastases may be allowed with specific criteria. 6. History of other primary malignancies, except cured or low-risk of recurrence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | approximately 24 months | Overall survival (OS) is defined as the time from randomization to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | approximately 24 months | ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) per RECIST v1.1. |
| disease control rate (DCR) | approximately 24 months | DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) per RECIST v1.1 criteria. |
| duration of response (DoR) | approximately 24 months | DoR is defined as the time from the first CR or PR to disease progression or death from any cause, whichever occurs first for subjects with ORR per RECIST v1.1 criteria. |
| time to response (TTR) | approximately 24 months | TTR is defined as the time from randomization to the first CR or PR for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria. |
| progression free survival(PFS) | approximately 24 months | Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause. |
| Area under the plasma concentration versus time curve (AUC) | approximately 24 months | area under the curve (AUC) of single and multiple doses of IBI343 |
| immunogenicity | approximately 24 months | anti-drug antibody and/or neutralizing antibody |
| maximum concentration (Cmax) | approximately 24 months | maximum concentration (Cmax) of single and multiple doses of IBI343 |
| time to maximum concentration (Tmax) | approximately 24 months | time to maximum concentration (Tmax) of single and multiple doses of IBI343 |
| Adverse Event | approximately 24 months | Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0. |
Countries
China
Contacts
Primary ContactPenglei Zheng
Outcome results
None listed