Clinical Trials Directory

Trials / Completed

CompletedNCT04504669

First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
60 (actual)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years – 101 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

Detailed description

This is a Phase I, First in Human, multicentre, open-label, multiple arm study with dose escalations and expansions at selected doses. Dose-escalation will occur with AZD8701 in monotherapy (Part 1) and in combination with durvalumab (Part 3) in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastroesophageal cancer, melanoma, cervical cancer, small-cell lung cancer and/or participants with solid tumours who have demonstrated a response to prior PD-(L)1 treatment. Disease specific expansions will occur with a selected dose of AZD8701 in participants with NSCLC (Part 2) and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC (Part 4).

Conditions

Interventions

TypeNameDescription
DRUGAZD8701FOXP3 antisense oligonucleotide
BIOLOGICALDurvalumabanti PDL-1 monoclonal antibody

Timeline

Start date
2020-08-18
Primary completion
2024-10-07
Completion
2024-10-07
First posted
2020-08-07
Last updated
2024-11-05

Locations

13 sites across 4 countries: United States, Canada, France, Spain

Regulatory

Source: ClinicalTrials.gov record NCT04504669. Inclusion in this directory is not an endorsement.