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OncoMatch/Clinical Trials/NCT05859750

A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer

Is NCT05859750 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for pancreatic cancer.

Phase 2RecruitingAkesoNCT05859750Data as of Jun 2026Location: China

Treatment: AK104 · AK104 · Gemcitabine · Nab-Paclitaxel · Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate · Oxaliplatin + Irinotecan + 5-Fluorouracil/LeucovorinThis study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104,a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

GemcitabineNab-PaclitaxelLiposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinateOxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin

Other

AK104AK104

Cancer type

Pancreatic Cancer

Biomarker criteria

Excluded: BRCA1 germline mutation

Excluded: BRCA2 germline mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: treatment targeting the mechanism of tumor immunity

Patients who received any prior treatments targeting the mechanism of tumor immunity [excluded].

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT05859750 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Are patients with BRCA1 alterations eligible?

No. BRCA1 germline mutation is an exclusion criterion.

Are patients with BRCA2 alterations eligible?

No. BRCA2 germline mutation is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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