Study identifier:D9950C00001
ClinicalTrials.gov identifier:NCT04504669
EudraCT identifier:2019-004539-22
CTIS identifier:N/A
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.
Clear Cell Renal Cell Cancer
Phase 1
No
AZD8701
All
63
Interventional
18 Years - 101 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
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
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).
Location
Location
Huntersville, NC, United States, 28078
Location
Madison, WI, United States, 53792
Location
Franklin, TN, United States, 37067
Location
Saint Louis, MO, United States, 63110
Location
Madrid, Spain, 28027
Location
Villejuif Cedex, France, 94805
Location
Toronto, ON, Canada, M5G 2M9
Location
Barcelona, Spain, 08035
Arms | Assigned Interventions |
---|---|
Experimental: Monotherapy Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years. | Drug: AZD8701 FOXP3 antisense oligonucleotide |
Experimental: Combination Therapy Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years. | Drug: AZD8701 FOXP3 antisense oligonucleotide Biological/Vaccine: Durvalumab anti PDL-1 monoclonal antibody Other Name: MEDI4736 |
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