Spots Global Cancer Trial Database for First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

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Trial Identification

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

Official Title: 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.

Study ID: NCT04504669

Conditions

Clear Cell Renal Cell Cancer

Non-Small-Cell Lung Cancer

Triple Negative Breast Neoplasms

Squamous Cell Cancer of Head and Neck

Small Cell Lung Cancer

Gastroesophageal Cancer

Melanoma

Cervical Cancer

Advanced Solid Tumours

Interventions

AZD8701

Durvalumab

Study Description

Brief 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).