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

NCT ID: NCT06646055

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2027-12-30

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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)

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.

Group Type: EXPERIMENTAL

AK112, Cadonilimab, nab-paclitaxel, gemcitabine

Intervention Type: DRUG

IV infusion, specified dose on specified days.

Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)

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.

Group Type: EXPERIMENTAL

AK112, Cadonilimab, nab-paclitaxel, gemcitabine

Intervention Type: DRUG

IV infusion, specified dose on specified days.

Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II)

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.

Group Type: EXPERIMENTAL

AK112, Cadonilimab, nab-paclitaxel, gemcitabine

Intervention Type: DRUG

IV infusion, specified dose on specified days.

AK112 + nab-paclitaxel + gemcitabine(phase II)

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.

Group Type: EXPERIMENTAL

AK112, nab-paclitaxel, gemcitabine

Intervention Type: DRUG

IV infusion, specified dose on specified days.

nab-paclitaxel + gemcitabine(phase II)

Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.

Group Type: ACTIVE_COMPARATOR

nab-paclitaxel, gemcitabine

Intervention Type: DRUG

IV infusion, specified dose on specified days.

Interventions

AK112, Cadonilimab, nab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

Intervention Type: DRUG

AK112, Cadonilimab, nab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

Intervention Type: DRUG

AK112, Cadonilimab, nab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

Intervention Type: DRUG

AK112, nab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

Intervention Type: DRUG

nab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenting Li, MD

Role: CONTACT

clinicaltrials@akesobio.com

+86(0760)89873999

Xianglin Yuan, MD

Role: CONTACT

Other Identifiers

AK112-210

Identifier Type: -

Identifier Source: org_study_id