A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: ONO-4538; Drug: Gemcitabine; Drug: ONO-7475; Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06532331

ONO-7475-04

Details and patient eligibility

About

This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment

Enrollment: 87 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with metastatic pancreatic cancer
2. Patients have an ECOG performance status of 0 to 1
3. Patients with a life expectancy of at least 6 months

Exclusion criteria

1. Patients are unable to swallow oral medications
2. Patients with severe complication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

ONO-7475+GnP

Experimental group

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: ONO-7475

ONO-7475＋ONO-4538＋GnP

Experimental group

Treatment:

Drug: Nab-paclitaxel

Drug: Gemcitabine

Drug: ONO-7475

Drug: ONO-4538