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AZD4785

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Oct 4, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

AZD4785 · 1 trial · 2 indications

Phase 1 1
NCT03101839Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid TumoursNon-Small Cell Lung Cancer
COMPLETED28 Analytics
PHASE1COMPLETED
Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid Tumours
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD)
Minimum of 28 days for a patient

Determined through the evaluation of dose-limiting toxicity (DLT), adverse events, clinical laboratory test results, clinical evaluation and patient reported symptoms

Secondary Endpoints

Peak plasma concentration (Cmax) of AZD4785
Samples for determination of AZD4785 plasma conc. will be collected at multiple times on Day 1 Cycle 1, pre-dose on Days 3, 5, and 8 of Cycle 1, Day 22 of Cycle 2, and Day 1 of Cycles 3 and 4. Time points may be adjusted based on emerging data.
Area under the plasma concentration versus time curve (AUC) for AZD4785
Samples for determination of AZD4785 plasma conc. will be collected at multiple times on Day 1 Cycle 1, pre-dose on Days 3, 5, and 8 of Cycle 1, Day 22 of Cycle 2, and Day 1 of Cycles 3 and 4. Time points may be adjusted based on emerging data.
Objective Clinical Response
Every 8 weeks up to 12 months.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD4785EXPERIMENTALThis is a single-arm study in which all patients will receive AZD4785 by IV infusion. Patients will continue to receive treatment with AZD4785 until disease progression, intolerable toxicity, or discontinuation criteria are met.

Interventions

NameTypeDescription
AZD4785DRUGKRAS Antisense Oligonucleotide
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria Part A Dose Escalation: Patients must have histological or cytological confirmation of a solid tumour known to harbour KRAS mutations (e.g., NSCLC, mCRC, pancreatic or cholangiocarcinoma), and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ie...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about AZD4785

What is AZD4785 used for?

AZD4785 is an investigational small molecule being developed for the treatment of Non-Small Cell Lung Cancer. It was studied in patients with advanced solid tumours, including Non-Small Cell Lung Cancer, in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes AZD4785?

AZD4785 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company conducted a Phase 1 clinical trial of AZD4785 in patients with advanced solid tumours.

What phase is AZD4785 in?

AZD4785 is in Phase 1 clinical development. A Phase 1 dose-escalation study of AZD4785 in patients with advanced solid tumours has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD4785 in?

AZD4785 was studied in one clinical trial, identified as NCT03101839, titled 'Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid Tumours'. This trial enrolled 28 participants and was conducted in the United States and United Kingdom. The trial has been completed.

Is AZD4785 the same as any other drug?

No alternative names for AZD4785 have been disclosed. The drug is identified by its code name AZD4785 in clinical trial records and is being developed by AstraZeneca PLC.