IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
ConditionAdvanced Pancreatic Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
This study is a phase II study to evaluate the safety, tolerability and efficacy of IBI343 combined with chemotherapy in patients with advanced pancreatic cancer, including Part1 (safe lead-in phase) and Part2 (extension phase). In part1, patients with CLDN18.2-positive advanced pancreatic adenocarcinoma who had or had not previously received systemic therapy were treated with chemotherapy in IBI343 with AG regimen (albumin paclitaxel with gemcitabine). In part2, 40 patients with CLDN18.2-positive advanced PDAC will be enrolled, 1:1 randomized to Arm A and Arm B, respectively. In Arm A, patients will receive IBI343 TBD + gemcitabine TBD + albumin-bound paclitaxel TBD; and in Arm B, patients will receive gemcitabine 1000mg / m2 d1, d8 Q3W + albumin-bound paclitaxel 125mg / m2d1, d8 Q3W treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent, willing and able to comply with the protocol specified visits and related procedures.
Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic pancreatic adenocarcinoma.
Subjects must not be eligible for radical treatment such as radical radiotherapy and / or surgery; time to disease recurrence / metastasis> 6 months for subjects with previous (new) adjuvant / adjuvant / radiotherapy) chemotherapy / radical chemoradiotherapy. In part 1: locally advanced or recurrent / metastatic stage with or without systemic therapy (including chemotherapy, targeted therapy, tumor immunotherapy, etc.). In part 2: The locally advanced or recurrent / metastasis phase has not received any systemic therapy (including chemotherapy, targeted therapy, tumor immunotherapy, etc.).
At least 1 measurable lesion (no previous radiotherapy) for solid tumors RECIST v1.1.(At baseline, computed tomography or magnetic resonance imaging showed the long diameter of 10 mm (except for lymph nodes, the short axis of the lymph node must be 15 mm), the diameter of the target lesion is 2 times the imaging layer thickness and the lesion is suitable for repeated accurate measurement. If a lesion located in the previously irradiated area clearly demonstrates a progression meeting the RECIST V1.1 criteria, the lesion acts as a measurable lesion).
Disqualifiers
Is participating in another interventional clinical study, except for an observational (non-interventional) clinical study or is in the survival follow-up phase of the interventional study.
Treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the study drug.
The last anti-tumor therapy within 4 weeks before the first dose of the study drug or within 5 half-lives of the anti-tumor treatment (whichever is shorter) (2 weeks for washout with no exact half-life).
Received therapeutic or palliative radiotherapy within 2 weeks prior to the first administration of the study drug.
Trial design
Design model
Parallel
Treatments tested in this trial
IBI343
DrugIBI343 is a recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate
Gemcitabine+Albumin-bound paclitaxel
DrugGemcitabine+ Albumin-bound paclitaxel is one of the recommended first line regime for advanced pancreatic cancer
Treatment groups
64 Participants
are divided into 3 treatment groupsGroup A: Part 1Experimental treatment 2 interventions
Group B: Part 2: Arm AExperimental treatment 2 interventions
Group C: Part 2: Arm BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study.
Time frame
Up to 2 years2
Adverse Event
Safety evaluation，such as hematotoxicity, hepatotoxicity, and renal function lab test, done continuously during treatment and the level of serum creatinine will be evaluated by using CTCAE 5.0 during study.
Time frame
Up to 2 years.Secondary outcomes
1
Progression-free Survival
The time from enrolled to disease pregression or death from any cause during the whole study.
Time frame
Up to 2 years.2
Duration of Response
The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during the whole study.
Time frame
Up to 2 years.3
Disease Control Rate
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.
Time frame
Up to 2 years.4
Time to Response
The time from the first treatment to the first assessment of the tumor as CR or PR during the whole study.
Time frame
Up to 2 years.Other outcomes
1
CLDN18.2 expression levels in tumor tissues
To evaluate the correlation of CLDN18.2 expression levels in tumor tissues and the efficacy of IBI343 combination therapy
Time frame
Up to 2 years.Sponsors and contacts
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Source ClinicalTrials.gov