Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Infections

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Stomach Neoplasms

Esophageal Neoplasms

Urinary Bladder Neoplasms

Melanoma

Carcinoma, Renal Cell

Carcinoma, Merkel Cell

Neoplasms, Second Primary

Neoplastic Processes

Stomach Cancer

Esophageal Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Merkel Cell Carcinoma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Aldesleukin

Immunomodulating Agents

Immunoglobulins

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

AU-007 (Q2w) will be administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort

AU-007 (Q2w) will be administered at a fixed dose in combination with a single dose of aldesleukin with the initial AU-007 dose. The aldesleukin dose will be escalated with each Dose Escalation Cohort

AU-007 will be administered at a fixed dose in combination with a aldesleukin, both administered Q2w. The aldesleukin dose will be escalated with each Dose Escalation Cohort

AU-007

John Powderly, MD

Meredith McKean

George Blumenschein

Drew Rasco

Siwen Hu-Lieskovan

Paul DeSouza

Elizabeth Ahern

Andrew Weickhardt

Andrew Haydon, MD

Catherine Oakman

James Vasselli, MD

This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w)

This is a first in human, multicenter, open-label Phase 1-2 study evaluating the safety, tolerability, and initial efficacy of AU-007 with or without aldesleukin, in patients with unresectable locally advanced or metastatic cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy. Phase 1 consists of 3 escalation Arms, each starting with a single 1+2 escalation cohort followed by 3+3 escalation cohorts to define the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD). The study begins in Arm A evaluating escalating doses of AU-007 (Q2w) in sequential escalation cohorts to define the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Arm B, AU-007 (Q2w) is evaluated in combination with a single dose of aldesleukin given with the first AU-007 dose. AU-007 is administered at a fixed dose (Q2w) with an escalating single aldesleukin dose in sequential escalation cohorts. In Arm C, AU-007 is evaluated in combination with aldesleukin both given Q2w. AU-007 will be administered at a fixed dose with an escalating dose of aldesleukin in each sequential Arm C escalation cohort. The Phase 2, cohort expansion portion of the study consists of three expansion Arms evaluating the initial efficacy of the RP2D from corresponding dose escalation Arms A, B, and C in selected solid tumor types. Initially, melanoma and renal cell cancer will be evaluated in each Arm. Other eligible cancers include but not limited to Merkel Cell Carcinoma, non-small cell lung cancer and urothelial cancer.

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Measured by the frequency of DLTs (Dose limiting Toxicity) and safety profile

With AU-007 alone or in combination with aldesleukin measured by PK, PD, and Biomarkers

The AUC of AU-007 will be measured at different timepoints after AU-007 administration

The Cmax of AU-007 will be measured at different timepoints after AU-007 administration

The Tmax of AU-007 will be measured at different timepoints after AU-007 administration

The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration

Assessed by summarizing the number of patients who develop detectable anti-drug antibodies (ADAs) at different timepoints after AU-007 alone or in combination with aldesleukin

Clinical anti-tumor activity will be evaluated using conventional Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST v1.1.

Aulos Bioscience, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Triple Negative Breast Neoplasms

Uterine Cervical Neoplasms

Small Cell Lung Carcinoma

Head and Neck Neoplasms

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

Small Cell Lung Cancer

Durvalumab

Atezolizumab

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer	NCT05267626	Advanced Solid ... Metastatic Canc...	AU-007 Aldesleukin	18 Years -	Aulos Bioscience, Inc.
First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours	NCT04504669	Clear Cell Rena... Non-Small-Cell ... Triple Negative... Squamous Cell C... Small Cell Lung... Gastroesophagea... Melanoma Cervical Cancer Advanced Solid ...	AZD8701 Durvalumab	18 Years - 101 Years	AstraZeneca

Spots Global Cancer Trial Database for clear cell renal cell cancer