Advanced Solid Tumors That Are MTAP DeficientPhase 1/2PRIMROSENCT06130553
A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing AZD3470 and Datopotamab deruxtecan in people with Advanced Solid Tumors That Are MTAP Deficient, run by AstraZeneca at 21 sites in 8 countries.
Trial summary
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors That Are MTAP Deficient
- What is being tested?
- AZD3470 and Datopotamab deruxtecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 18 Jan 2024to 4 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria (All Modules) Participants are ≥ 18 years (or the legal age of consent in the jurisdiction) at the time of signing the informed consent form.
Participants are able to provide written informed consent and are willing and able to comply with study procedures.
Participants are willing to provide archival and/or newly obtained (baseline) tumor tissue for central testing, including required biomarker assessment(s) (and any module-specific biomarker requirements).
Participants have tumors meeting the protocol-defined MTAP-deficiency requirement, based on acceptable prior testing and/or central testing per protocol.
Participants have received prior systemic therapy appropriate for the tumor type and disease stage and have disease progression on or after prior therapy; participants must have had ≥ 1 prior line of systemic treatment in the recurrent/metastatic (advanced) setting.
Participants have ECOG performance status 0-1. Participants have life expectancy ≥ 12 weeks, in the opinion of the Investigator.
Participants have measurable disease per RECIST v1.1. Participants have adequate organ and bone marrow function per protocol-defined laboratory/assessment criteria.
Participants have a treatment-free interval ≥ 3 weeks from prior anticancer therapy before starting study drug (with any additional protocol-defined washout requirements for certain therapies/procedures).
Contraception use by men and women is consistent with local regulations and protocol-defined requirements.
Additional Inclusion Criteria (Module 2: Non-squamous NSCLC) Participants have histologically or cytologically confirmed non-squamous NSCLC, Stage IIIB/IIIC not amenable to curative therapy or Stage IV.
Participants have documented radiographic extracranial disease progression while on or after the most recent treatment regimen for advanced/metastatic NSCLC (CNS-only progression is not eligible).
NSCLC of mixed histology is allowed if not predominantly squamous; no small cell or large cell neuroendocrine components.
Participants meet one of the following:
Tumor has a documented EGFR alteration eligible for EGFR-directed therapy (per protocol-defined criteria) and the participant has received prior systemic therapy appropriate for EGFR-altered advanced/metastatic NSCLC (per protocol), OR Tumor is negative for EGFR alterations eligible for EGFR-directed therapy, has no other known actionable genomic alterations for which locally approved/available targeted therapies exist (per protocol-defined criteria), meets any additional protocol-required biomarker criteria for this cohort (as applicable), and the participant has received prior systemic therapy appropriate for non-actionable-alteration advanced/metastatic NSCLC (per protocol).
Exclusion Criteria (All Modules) Participants have spinal cord compression, or symptomatic and unstable brain metastases, leptomeningeal disease, or primary CNS malignancy. Participants with asymptomatic, radiographically stable brain metastases who do not require steroids (or who have completed definitive therapy and are neurologically stable off steroids, per protocol) may be eligible.
Participants have a history of allogeneic organ transplantation. Participants have any clinically significant abnormal laboratory finding or severe and uncontrolled medical condition that, in the Investigator's opinion, makes participation unsafe, including active infection requiring systemic treatment.
Participants have clinically significant cardiovascular disease or risk factors (including reduced LVEF, cardiomyopathy, clinically active cardiovascular disease, recent major ischemic events or revascularization procedures, uncontrolled angina, severe valvular disease, uncontrolled hypertension, clinically significant heart failure, or recent stroke/TA clinically significant ECG abnormalities, prolonged QTc, or conditions/medications that increase risk of QTc prolongation or arrhythmic events)..
Participants require therapeutic anticoagulation for treatment of acute thromboembolic events, per protocol.
Participants have active hepatitis B or hepatitis C infection (including detectable viral load, per protocol-defined testing).
Participants have known HIV infection. Participants have current ILD/pneumonitis, or a history of (non-infectious) ILD/pneumonitis requiring systemic steroids or supplemental oxygen, or suspected ILD/pneumonitis that cannot be ruled out by screening imaging.
Participants have active gastrointestinal disease, malabsorption, or other GI condition/surgery that would significantly interfere with oral drug absorption or tolerability.
Participants have a history of another primary malignancy. Participants have unresolved clinically significant toxicity from prior anticancer therapy (typically Grade ≥ 2).
Participants have had prior treatment with a PRMT5 inhibitor Participants are pregnant, breastfeeding, or intend to become pregnant during study participation.
Additional Exclusion Criteria (Module 2 Only) Participants have inaccessible veins and/or inability to place required venous access (e.g., port), per Investigator judgment.
Participants have contraindication to required CNS imaging (brain MRI preferred or CT with contrast).
Participants have clinically significant corneal disease. Participants have known active tuberculosis infection, per clinical evaluation and local practice.
Participants have significant third-space fluid (e.g., pleural effusion/ascites) not amenable to required repeated drainage, per Investigator judgment.
Participants have severe pulmonary function compromise due to intercurrent pulmonary illness (e.g., severe COPD/asthma/restrictive lung disease, recent pulmonary embolism), per protocol.
Participants have recent radiotherapy that does not meet protocol-defined washout requirements and/or ongoing radiation-related toxicities requiring corticosteroids.
Participants have had prior treatment with protocol-prohibited anticancer therapies.
Trial locations and contacts
21 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
21 sites in 8 countries
United States8 sites, 7 recruiting
- Recruiting
Research Site
Baltimore, Maryland, 21231
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
New Haven, Connecticut, 06510
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Research Site
Portland, Oregon, 97239
- Recruiting
Research Site
Providence, Rhode Island, 02903
- Recruiting
Research Site
San Francisco, California, 94143
- Withdrawn
Research Site
West Hollywood, California, 90048
China4 sites, 4 recruiting
- Recruiting
Research Site
Beijing, 100142
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Shanghai, 200433
- Not yet recruiting
Research Site
Wuhan, 430030
Japan2 sites, 2 recruiting
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Kashiwa, 227-8577
South Korea2 sites, 2 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 06351
Spain2 sites, 2 recruiting
- Recruiting
Research Site
Barcelona, 8035
- Recruiting
Research Site
Madrid, 28027
About this study
Official title: PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced/Metastatic Solid Tumors That Are MTAP Deficient
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.
Read the detailed description
This first time in human, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency follows a modular design. Module 1 Part A will include the dose escalation cohorts. Part B will include the dose optimization and expansion cohorts. The purpose of the Phase 2 Module 2 is to evaluate the efficacy and safety of AZD3470 in combination with Dato-DXd versus Dato-DXd alone - dose optimization and expansion. New modules for combination treatments may be added in the future based on emerging data.
- Being tested
- AZD3470, Datopotamab deruxtecan
- Keywords
- solid tumor, MTAP deficient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3470Drug
AZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5.
Datopotamab deruxtecanDrug
Also called Dato-DXd
AZD3470 in combination with Dato-DXd + Dato-Dxd monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Module 1: AZD3470 Monotherapy | Experimental | Part A dose escalation and back-fill cohorts and Part B dose optimization and expansion cohorts of varying doses of AZD3470 Receives: Drug: AZD3470 |
| Module 2: AZD3470 in combination with Dato-DXd | Experimental | Varying doses of AZD3470 in combination with Dato-Dxd Receives: Drug: AZD3470; Drug: Datopotamab deruxtecan |
| Module 2: Dato-DXd alone | Experimental | Control arm Receives: Drug: Datopotamab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Modules: Incidence of adverse events (AEs) and serious adverse events (SAEs). To determine the RP2D of AZD3470 as monotherapy and in combination with anticancer agents
Number of participants with AEs and SAEs.
Measured: From time of informed consent to 28 days post last dose of study treatment
Module 1: Incidence of dose-limiting toxicities (DLT)
Incidence of dose-limiting toxicities (DLT) as determined by number of patients with at least 1 dose-limiting toxicity (DLT)
Measured: From first dose of study treatment until the end of Cycle 1 (each cycle is 21 days)
Module 2: Progression Free Survival assessed by the Investigator according to RECIST v1.1
PFS - defined as time from date of randomization until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause.
Measured: From date of randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
Secondary outcomes (19)
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - ORR (Objective Response Rate)
Proportion of participants who have a complete or partial radiological response as determined by the Investigator according to RECIST v1.1
Measured: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - DoR (Duration of Response)
DoR - the time from date of first documented objective response until date of documented disease progression per Tumor RECIST v1.1 as assessed by the Investigator at local site or death due to any cause.
Measured: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - Best percentage change in tumor size
Best percentage change from baseline in TL (target lesion) tumor size is based on the RECIST 1.1. TL measurements as assessed by the Investigator.
Measured: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
Module 1: Progression Free Survival assessed by the Investigator evaluated according to RECIST v1.1
PFS - defined as time from date of first dose (nonrandomized study parts) or date of randomization (randomized study parts) until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause.
Measured: From date of first dose/randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - DCR (Disease Control Rate) at 12 weeks
DCR at 12 weeks defined as the percentage of participants who have a CR (complete response) or PR (partial response) or who have SD (stable disease) per RECIST 1.1 as assessed by the Investigator at local site and derived from the raw tumor data for at least 11 weeks after date of first dose to allow for an early assessment within the assessment window.
Measured: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks).
All modules: Overall Survival (OS)
Overall Survival (OS) - defined as time from date of first dose (nonrandomized study parts) or date of randomization (randomized study parts) until the date of death due to any cause.
Measured: From date of first dose of AZD3470 up until the date of death due to any cause (approximately 2 years).
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: AUC
Part A (Dose escalation) Measurement of PK parameters: Area under the concentration time curve (AUC).
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: C-max
Part A (Dose escalation) Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max).
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: half life
Part A (Dose escalation) Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: Ae (excreted in urine)
Part A (Dose escalation) Measurement of PK parameters: amount of AZD3470 excreted in urine (Ae).
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: Clr (renal clearance)
Part A (Dose escalation) Measurement of PK parameters: renal clearance (Clr).
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A drug-drug interaction (DDI) - Measurement of PK parameters of Midazolam: Cmax
Part A (DDI)- Plasma geometric mean ratio (Maximum observed plasma concentration of the study drug (C-max)) of Midazolam evaluated with and without AZD3470
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Midazolam: AUC
Part A (DDI) - Plasma geometric mean ratio (Area under the concentration time curve (AUC)) of Midazolam evaluated with and without AZD3470
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: Cmax
Part A (DDI)- Plasma geometric mean ratio (Maximum observed plasma concentration of the study drug (C-max)) of Dextromethorphan evaluated with and without AZD3470
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: AUC
Part A (DDI) - Plasma geometric mean ratio (Area under the concentration time curve (AUC)) of Dextromethorphan evaluated with and without AZD3470
Measured: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A pharmacodynamic backfill cohorts - Measurement of SDMA in tumor.
Part A pharmacodynamic backfill- Percentage change from baseline tumor SDMA as measured by immunohistochemistry.
Measured: From screening baseline timepoint to up to four weeks on treatment timepoint.
Module 2: Time to response (TTR)
The time from date of randomization until the date of first documented objective response, per RECIST 1.1. as assessed by the investigator
Measured: From randomization until the date of first documented objective response, per RECIST v1.1 as assessed by the investigator
Module 2: PK parameters of AZD3470 and Dato-DXd
Measurement of PK parameters:
- Maximum total plasma concentration Cmax
- Time to maximum concentration Tmax
- Area under total plasma concentration curve AUC
Measured: From C1D1 until EOT/28 Day Follow Up
Module 2: Presence of ADAs (anti-drug antibody) for Dato-DXd
To evaluate the immunogenicity of Dato-DXd Presence of ADAs (anti-drug antibody) for Dato-DXd
Measured: From C1D1 until EOT/28 Day Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start18 Jan 2024
- Primary completion4 Dec 2028 (estimated)
- Study completion4 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors That Are MTAP DeficientStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a FTiH (first time in human), modular Phase I/IIa, open-label, multi-centre study of AZD3470 as Monotherapy and in Combination with Anti-cancer agents, in participants with MTAP deficient advanced/metastatic solid tumors. The study consists of individual modules, each evaluating safety and tolerability of AZD3470 dosed as a monotherapy or in combination with specific treatments. Module 1 describes AZD3470 monotherapy, and will have at least two parts. Part A consisting of dose escalation cohorts and Part B consisting of optimization and expansion cohorts. Module 2 describes AZD3470 in combination with Dato-DXd and will consist of cohorts of AZD3470 in combination with Dato-DXd and a cohort of Dato-DXd as monotherapy
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130553
- Sponsor's protocol ID
- D9970C00001
- Other IDs
- 165618
- Acronym
- PRIMROSE
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced/Metastatic Solid Tumors That Are MTAP Deficient
- ClinicalTrials.gov ID
- NCT06130553
- Acronym / sponsor ID
- PRIMROSE / D9970C00001
- Keywords
- solid tumor, MTAP deficient
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 4 Dec 2028 (estimated)
- Study completion
- 4 Dec 2028 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.
Detailed description
This first time in human, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency follows a modular design. Module 1 Part A will include the dose escalation cohorts. Part B will include the dose optimization and expansion cohorts. The purpose of the Phase 2 Module 2 is to evaluate the efficacy and safety of AZD3470 in combination with Dato-DXd versus Dato-DXd alone - dose optimization and expansion. New modules for combination treatments may be added in the future based on emerging data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a FTiH (first time in human), modular Phase I/IIa, open-label, multi-centre study of AZD3470 as Monotherapy and in Combination with Anti-cancer agents, in participants with MTAP deficient advanced/metastatic solid tumors. The study consists of individual modules, each evaluating safety and tolerability of AZD3470 dosed as a monotherapy or in combination with specific treatments. Module 1 describes AZD3470 monotherapy, and will have at least two parts. Part A consisting of dose escalation cohorts and Part B consisting of optimization and expansion cohorts. Module 2 describes AZD3470 in combination with Dato-DXd and will consist of cohorts of AZD3470 in combination with Dato-DXd and a cohort of Dato-DXd as monotherapy
| Arm | Type | Receives |
|---|---|---|
| Module 1: AZD3470 Monotherapy | Experimental | Drug: AZD3470Part A dose escalation and back-fill cohorts and Part B dose optimization and expansion cohorts of varying doses of AZD3470 |
| Module 2: AZD3470 in combination with Dato-DXd | Experimental | Drug: AZD3470, Drug: Datopotamab deruxtecanVarying doses of AZD3470 in combination with Dato-Dxd |
| Module 2: Dato-DXd alone | Experimental | Drug: Datopotamab deruxtecanControl arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD3470AZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5. | Drug | Module 1: AZD3470 Monotherapy, Module 2: AZD3470 in combination with Dato-DXd |
| Datopotamab deruxtecanAlso: Dato-DXdAZD3470 in combination with Dato-DXd + Dato-Dxd monotherapy | Drug | Module 2: AZD3470 in combination with Dato-DXd, Module 2: Dato-DXd alone |
Primary outcome
All Modules: Incidence of adverse events (AEs) and serious adverse events (SAEs). To determine the RP2D of AZD3470 as monotherapy and in combination with anticancer agents
Time frame: From time of informed consent to 28 days post last dose of study treatment
Number of participants with AEs and SAEs.
Module 1: Incidence of dose-limiting toxicities (DLT)
Time frame: From first dose of study treatment until the end of Cycle 1 (each cycle is 21 days)
Incidence of dose-limiting toxicities (DLT) as determined by number of patients with at least 1 dose-limiting toxicity (DLT)
Module 2: Progression Free Survival assessed by the Investigator according to RECIST v1.1
Time frame: From date of randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
PFS - defined as time from date of randomization until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause.
19 secondary outcomes
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - ORR (Objective Response Rate)
Time frame: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - DoR (Duration of Response)
Time frame: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - Best percentage change in tumor size
Time frame: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
Module 1: Progression Free Survival assessed by the Investigator evaluated according to RECIST v1.1
Time frame: From date of first dose/randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - DCR (Disease Control Rate) at 12 weeks
Time frame: From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks).
All modules: Overall Survival (OS)
Time frame: From date of first dose of AZD3470 up until the date of death due to any cause (approximately 2 years).
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: AUC
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: C-max
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: half life
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: Ae (excreted in urine)
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (Dose escalation) Measurement of PK parameters: Clr (renal clearance)
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A drug-drug interaction (DDI) - Measurement of PK parameters of Midazolam: Cmax
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Midazolam: AUC
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: Cmax
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A (DDI) - Measurement of PK parameters of Dextromethorphan: AUC
Time frame: At predefined intervals throughout the treatment period (for each patient this is expected to be measured up to approximately 4 weeks)
Module 1 Endpoints Part A pharmacodynamic backfill cohorts - Measurement of SDMA in tumor.
Time frame: From screening baseline timepoint to up to four weeks on treatment timepoint.
Module 2: Time to response (TTR)
Time frame: From randomization until the date of first documented objective response, per RECIST v1.1 as assessed by the investigator
Module 2: PK parameters of AZD3470 and Dato-DXd
Time frame: From C1D1 until EOT/28 Day Follow Up
Module 2: Presence of ADAs (anti-drug antibody) for Dato-DXd
Time frame: From C1D1 until EOT/28 Day Follow Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD3470 and Datopotamab deruxtecan in people with Advanced Solid Tumors That Are MTAP Deficient, run by AstraZeneca at 21 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, China, Japan, South Korea, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Modules: Incidence of adverse events (AEs) and serious adverse events (SAEs). To determine the RP2D of AZD3470 as monotherapy and in combination with anticancer agents (time frame: From time of informed consent to 28 days post last dose of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.