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AZD7789

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Oct 9, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

AZD7789 · 1 trial · 3 indications

Phase 1 1
NCT04931654A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid CancerCarcinoma, Non-Small-Cell Lung
ACTIVE NOT_RECRUITING136 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
Carcinoma, Non-Small-Cell Lung
NCT04931654136
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Study Endpoints

Primary Endpoints

Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE)
From time of Informed Consent to 90 days post last dose of study intervention

Number of participants with AEs, SAEs, imAEs including AEs leading to discontinuation of study intervention and clinically significant alterations in vital signs, laboratory parameters and ECG results

Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol
From the first patient until the end of the dose escalation period; approximately 18 months.

A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

Preliminary anti-tumour activity of AZD7789
From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.

Objective response rate as defined by RECIST v1.1

Secondary Endpoints

Objective response rate
From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.
Disease control rate
From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
Duration of response
From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistanceEXPERIMENTALAZD7789 monotherapy
Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1EXPERIMENTALAZD7789 Monotherapy
Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1EXPERIMENTALAZD7789 Monotherapy
Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2EXPERIMENTALAZD7789 Monotherapy
Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1EXPERIMENTALAZD7789 monotherapy
Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1EXPERIMENTALAZD7789 monotherapy

Interventions

NameTypeDescription
AZD7789DRUGanti-PD-1 and anti-TIM-3 bispecific antibody
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Must be ≥ 18 years of age * Part A Dose-escalation cohorts and Part B Dose-expansion cohorts B1, B2, B3 and B5: Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation. * Part B Dose-expans...

Countries:United StatesCanadaChinaFranceGeorgiaJapanMoldovaNetherlandsSpainTurkey (Türkiye)
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Frequently asked questions about AZD7789

What is AZD7789 used for?

AZD7789 is an investigational small molecule being studied for the treatment of advanced or metastatic solid cancers, including non-small-cell lung carcinoma, gastric cancer, and gastroesophageal junction cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing AZD7789?

AZD7789 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced or metastatic solid tumors.

What phase is AZD7789 in?

AZD7789 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for any use. The ongoing Phase 1 trial is assessing its safety and efficacy in participants with advanced or metastatic solid cancers, including non-small-cell lung carcinoma.

What clinical trials is AZD7789 in?

AZD7789 is being studied in a Phase 1 clinical trial registered as NCT04931654. This trial, titled 'A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer,' is active but not recruiting participants. It has an enrollment of 136 participants and is being conducted in multiple countries.

Is AZD7789 being studied in non-small-cell lung cancer?

Yes, AZD7789 is being studied in non-small-cell lung carcinoma as part of a Phase 1 clinical trial. The trial also includes patients with gastric cancer and gastroesophageal junction cancer. The study is evaluating the drug's safety and efficacy in these advanced or metastatic solid tumor types.

Is AZD7789 a controlled trial?

Yes, the Phase 1 clinical trial of AZD7789 is a controlled study, but it is not double-blinded. The trial is randomized and includes a control group. It is actively enrolling or has enrolled participants aged 18 years and older, regardless of sex, at sites in the United States, Canada, China, and other countries.