Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Breast Neoplasms

Triple Negative Breast Neoplasms

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Carcinoma

Neoplasms, Squamous Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms by Histologic Type

Skin Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Breast Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Small Cell Lung Cancer

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Durvalumab

Atezolizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.

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.

AZD8701

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).

This is a Phase I, FIH, multicentre, open-label, multiple arm study. Dose-escalation will occur with AZD8701 in monotherapy and in combination with durvalumab in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastroesophgeal 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 and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC.

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.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Determined according to Incidence and treatment related AEs and SAEs

Determined according to Incidence of DLTs (during the first 28 day cycle)

Determined according to Incidence of abnormal vital signs and laboratory parameters

Safety and tolerability of the MTD/OBD/MFD assessed through incidence of AEs and SAEs

The proportion of subjects achieving a confirmed complete or partial response according to RECIST 1.1 by investigator assessment

Time from start of study treatment to the date of objective disease progression or death (by any cause in the absence of progression)

Time from first documented response (that is subsequently confirmed) to the date of objective disease progression or death (by any cause in the absence of progression)

The proportion of subjects with a best response of CR or PR in the first 16 weeks or SD for at least 16 weeks according to RECIST 1.1 by investigator assessment

Time from the start of study treatment until the date of first documented response (which is subsequently confirmed)

Best percentage change from baseline in sum of the diameters of target lesions

The survival rate of subjects at 18 months from start of treatment

Maximum concentration (Cmax) of AZD8701 in plasma

Time to maximum concentration (tmax) of AZD8701 in plasma

Exposure to AZD8701 through measurement of area under the curve (AUC) in plasma

Maximum concentration (Cmax) of AZD8701 in urine

Time to maximum concentration (tmax) of AZD8701 in urine

Exposure to AZD8701 through measurement of area under the curve (AUC) in urine

Urine samples will be collected to assess urine concentrations of AZD8701 at a series of timepoints to derive renal clearance

Maximum concentration (Cmax) of Durvalumab in serum

Minimum concentration (Cmin) of Durvalumab in serum

Percentage change in FOXP3 mRNA expression from pre-treatment (baseline) to post treatment

Spots Global Cancer Trial Database for ccrenal cancer