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

NCT06646055 | Active Not Recruiting Phase 1

• 1 other identifier: AK112-210
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Frequency of adverse events (AEs) and serious adverse events (SAEs)

  Frequency of AEs and SAEs for all Arms in phase Ib.

  28days+28days

• Overall Response Rate (ORR)

  ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

  Up to approximately 2 years

Secondary Outcomes (7)

• Pharmacokinetics (PK)

  Up to Cycle 12

• Anti-Drug Antibodies(ADAs)

  Up to approximately 2 years

• Progression-Free Survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

Study Arms (5)

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

EXPERIMENTAL

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.

Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

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

EXPERIMENTAL

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.

Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

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

EXPERIMENTAL

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.

Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

AK112 + nab-paclitaxel + gemcitabine(phase II)

EXPERIMENTAL

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.

Drug: AK112, nab-paclitaxel, gemcitabine

nab-paclitaxel + gemcitabine(phase II)

ACTIVE COMPARATOR

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

Drug: nab-paclitaxel, gemcitabine

Interventions

AK112, nab-paclitaxel, gemcitabine DRUG

IV infusion, specified dose on specified days.

AK112 + nab-paclitaxel + gemcitabine(phase II)

nab-paclitaxel, gemcitabine DRUG

IV infusion, specified dose on specified days.

nab-paclitaxel + gemcitabine(phase II)

AK112, Cadonilimab, nab-paclitaxel, gemcitabine DRUG

IV infusion, specified dose on specified days.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• ≥18 years old and ≤ 75 years (regardless of sex).
• ECOG performance status 0-1
• Life expectancy longer than 3 months.
• Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal carcinoma (PDAC).
• No prior systemic anti-tumor therapy for metastatic PDAC.
• Adequate organ function.
• Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

You may not qualify if:

• Histological or cytological diagnosis of other pathological types.
• BRCA1/2 or PALB2 mutations.
• Participating in another clinical research.
• Active central nervous system (CNS) metastases.
• Undergoing systemic antiangiogenic therapy.
• Acute or subacute pancreatitis.
• Other known malignancies within five years.
• Active infection requiring systemic therapy.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

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

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)