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AZD4785

Phase 1

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

AZD4785 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

AZD4785 clinical trials

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 541 trials

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK37PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3ABBV-1480, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab
AstraZeneca PLCAZN68PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE20PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS12PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
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Frequently asked questions about AZD4785

What is AZD4785 used for?

AZD4785 is an investigational small molecule developed for the treatment of non-small cell lung cancer and other advanced solid tumors. It was studied in a Phase 1 dose-escalation trial in adults with advanced disease. It is not an approved therapy and remains in clinical development.

Who is developing AZD4785?

AZD4785 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 1 dose-escalation study of the compound in patients with advanced solid tumors, including non-small cell lung cancer.

What phase is AZD4785 in?

AZD4785 is in Phase 1 development. One Phase 1 dose-escalation trial has been completed, and no trials of the drug are currently active. The study enrolled 28 patients and was conducted in the United States and the United Kingdom.

What clinical trials is AZD4785 in?

AZD4785 was evaluated in one Phase 1 trial, NCT03101839, titled a Phase I Dose-Escalation Study of AZD4785 in Patients With Advanced Solid Tumours. The trial enrolled 28 adults, was uncontrolled and open-label, and has completed. It included patients with non-small cell lung cancer and advanced solid tumors.

Is AZD4785 FDA approved?

AZD4785 is not approved. It is an investigational agent that has completed a single Phase 1 dose-escalation trial in advanced solid tumors, including non-small cell lung cancer. No active trials of AZD4785 are ongoing, and the compound remains in early clinical development.

Was AZD4785 studied in biomarker-selected patients?

Yes. The Phase 1 trial of AZD4785, NCT03101839, was biomarker-selected, meaning enrollment was guided by a molecular biomarker rather than an unselected patient population. The study enrolled 28 adults with advanced solid tumors, including non-small cell lung cancer, across sites in the United States and the United Kingdom.