A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

Akeso

Status and phase: Not yet enrolling; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: AK112; Drug: AK130

Study type: Interventional

Funder types: Industry

Identifiers

NCT07114315

AK130-202

Details and patient eligibility

About

This is an open-label, multi-center phase II clinical study consisting of two parts:

Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer.

Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be able and willing to provide written informed consent.
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
5. According to RECIST v1.1, there is at least one measurable lesion.
6. Has adequate organ function.
7. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 90 days after the last dose of study treatment.
8. Able to to comply with all requirements of study participation (including all study procedures).

Exclusion criteria

1. Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.
2. There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
3. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
4. Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.
5. There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
6. History of severe bleeding tendency or coagulation dysfunction.
7. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
8. Pregnant or lactating female subject.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

AK112 in combination with AK130

Experimental group

Treatment:

Drug: AK130

Drug: AK112

AK112

Experimental group

Treatment:

Drug: AK112