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

Akeso

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Treatments

Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

Drug: AK112, nab-paclitaxel, gemcitabine

Drug: nab-paclitaxel, gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06646055

AK112-210

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 5 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

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

Experimental group

Description:

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.

Treatment:

Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

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

Experimental group

Description:

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.

Treatment:

Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine

AK112 + nab-paclitaxel + gemcitabine(phase II)

Experimental group

Description:

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.

Treatment:

Drug: AK112, nab-paclitaxel, gemcitabine

nab-paclitaxel + gemcitabine(phase II)

Active Comparator group

Description:

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

Treatment:

Drug: nab-paclitaxel, gemcitabine