AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer

Phase 1

Recruiting

• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: AK112, nab-paclitaxel, gemcitabine; Drug: nab-paclitaxel, gemcitabine; Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

• Registration Number: NCT06646055
• Lead Sponsor: Akeso

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-17
• Status Verified: 2025-01
• Study Start: 2025-01-21
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK112 + nab-paclitaxel + gemcitabine(phase II)	AK112, nab-paclitaxel, gemcitabine	AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
nab-paclitaxel + gemcitabine(phase II)	nab-paclitaxel, gemcitabine	Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)	AK112, Cadonilimab, nab-paclitaxel, gemcitabine	Cadonilimab will be administered at a selected dose every 4 weeks (q4w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)	AK112, Cadonilimab, nab-paclitaxel, gemcitabine	Cadonilimab will be administered at a selected dose every 2 weeks (q2w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II)	AK112, Cadonilimab, nab-paclitaxel, gemcitabine	Cadonilimab will be administered at a selected dose and frequency from phase Ib. AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs) and serious adverse events (SAEs)	28days+28days	Frequency of AEs and SAEs for all Arms in phase Ib.
Overall Response Rate (ORR)	Up to approximately 2 years	ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Up to approximately 2 years	Evaluation of DCR based on RECIST v1.1.
Duration of Response (DoR)	Up to approximately 2 years	Evaluation of DoR based on RECIST v1.1.
Time to Response (TTR)	Up to approximately 2 years	Evaluation of TTR based on RECIST v1.1.
Progression-Free Survival (PFS)	Up to approximately 2 years	Evaluation of PFS based on RECIST v1.1.
Overall survival (OS)	Up to approximately 2 years	Evaluation of OS based on RECIST v1.1.
Pharmacokinetics (PK)	Up to Cycle 12	PK parameters: serum concentrations of AK112 and Cadonilimab at different point of time
Anti-Drug Antibodies(ADAs)	Up to approximately 2 years	Number and percentage of patients with detectable anti-drug antibodies

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.; 🇨🇳 Wuhan, Hubei, China