AK130 combined with AK112 for advanced pancreatic cancer

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

This phase II test looks at whether combining AK130 with AK112, or giving AK112 alone, can help people with advanced pancreatic cancer who have progressed after up to two prior systemic therapies.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07114315 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter phase II program for adults with advanced or metastatic pancreatic ductal adenocarcinoma who have progressed on no more than two prior systemic treatments. Part I gives patients the combination of AK130 plus AK112 to collect safety and early efficacy data, while Part II evaluates AK112 as monotherapy or in combination with AK130. Eligible patients must have measurable disease by RECIST v1.1, ECOG performance status 0–1, adequate organ function, and a life expectancy of at least three months. Regular imaging and safety monitoring are performed at participating oncology centers in China.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically or cytologically confirmed metastatic or unresectable pancreatic ductal adenocarcinoma, ECOG 0–1, measurable disease, life expectancy ≥3 months, adequate organ function, and progression after ≤2 prior systemic therapies.

Not a fit: Patients with recent other malignancies within five years (other than PDAC), active central nervous system metastases or spinal/meningeal involvement, ECOG >1, or who have received more than two prior systemic regimens are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, these regimens could provide a new treatment option that slows disease progression and may extend survival for some patients with advanced pancreatic cancer.

How similar studies have performed: While combination immune-targeted strategies have shown activity in some tumor types, they have generally yielded limited benefit in pancreatic cancer to date, so this approach remains exploratory.

Eligibility criteria

Inclusion Criteria:

* Be able and willing to provide written informed consent.
* Have a life expectancy of at least 3 months.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
* According to RECIST v1.1, there is at least one measurable lesion.
* Has adequate organ function.
* 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.
* Able to to comply with all requirements of study participation (including all study procedures).

Exclusion Criteria:

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

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Zhongshan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wenting Li

Conditions Pancreatic Cancer