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Trial Title:
AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer
NCT ID:
NCT06646055
Condition:
Metastatic Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK112, Cadonilimab, nab-paclitaxel, gemcitabine
Description:
IV infusion, specified dose on specified days.
Arm group label:
Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
Intervention type:
Drug
Intervention name:
AK112, Cadonilimab, nab-paclitaxel, gemcitabine
Description:
IV infusion, specified dose on specified days.
Arm group label:
Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
Intervention type:
Drug
Intervention name:
AK112, Cadonilimab, nab-paclitaxel, gemcitabine
Description:
IV infusion, specified dose on specified days.
Arm group label:
Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II)
Intervention type:
Drug
Intervention name:
AK112, nab-paclitaxel, gemcitabine
Description:
IV infusion, specified dose on specified days.
Arm group label:
AK112 + nab-paclitaxel + gemcitabine(phase II)
Intervention type:
Drug
Intervention name:
nab-paclitaxel, gemcitabine
Description:
IV infusion, specified dose on specified days.
Arm group label:
nab-paclitaxel + gemcitabine(phase II)
Summary:
This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC)
patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The
purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab
combined with chemotherapy as first-line treatment for patients with metastatic
pancreatic cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Be able and willing to provide written informed consent and to comply with all
requirements of study participation (including all study procedures).
2. ≥18 years old and ≤ 75 years (regardless of sex).
3. ECOG performance status 0-1
4. Life expectancy longer than 3 months.
5. Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal
carcinoma (PDAC).
6. No prior systemic anti-tumor therapy for metastatic PDAC.
7. Adequate organ function.
8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST)
1.1.
Exclusion Criteria:
1. Histological or cytological diagnosis of other pathological types.
2. BRCA1/2 or PALB2 mutations.
3. Participating in another clinical research.
4. Active central nervous system (CNS) metastases.
5. Undergoing systemic antiangiogenic therapy.
6. Acute or subacute pancreatitis.
7. Other known malignancies within five years.
8. Active infection requiring systemic therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 10, 2024
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646055
