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AZD7789

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04931654A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid CancerPHASE1 ACTIVE NOT_RECRUITING 136 — — Sep 28, 2021Aug 12, 2026Oct 9, 202521 United States, Canada +8
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04931654primaryCompletionDate: changed
LOWMay 24, 2026NCT04931654studyFirstPostDate: changed