Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours

Conditions

• Locally Advanced or Metastatic Solid Tumours

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• AZD0171 — DRUG
  AZD0171
• Durvalumab — DRUG
  Durvalumab
• Gemcitabine — DRUG
  Chemotherapy (Standard-of-Care)
• Nab-paclitaxel — DRUG
  Chemotherapy (Standard-of-Care)

Study Details

The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).

Key Dates

Start date

Dec 10, 2021

Status verified

Apr 2026

Primary completion

Oct 7, 2024

Completion

Jun 30, 2026

Study Design

Enrollment

126 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: AZD0171 + Durvalumab + chemotherapy
  Participants will receive AZD0171 (intravenous \[IV\]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel).

Primary Outcome Measure

Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs) [ Time Frame: From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months ]

Locations (16)

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