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Phase 1Recruiting
View on ClinicalTrials.gov

Comparing 3 approaches for advanced solid tumor

Official title: A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors

Condition: Advanced Solid TumorSponsor: Daiichi SankyoTarget enrollment: 108
  • Phase 1
  • 3 groups
  • One site, in Toronto
  • Recruiting
Princess Margaret Cancer Centre, University Health Network, Toronto

Interventions

  • Medication

    DS-1103a

    One IV infusion Q3W on Day 1 of each 21-day cycle

  • Medication

    T-DXd

    One IV infusion Q3W on Day 1 of each 21-day cycle

Canadian Sites (1)

1 of 1 recruiting

  • Princess Margaret Cancer Centre, University Health Network

    Toronto

    Recruiting

Eligibility Criteria

See who this study is looking for40 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Sign and date the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF), prior to the start of any study-specific qualification procedures
  • +Adults ≥18 years of age at the time the ICF is signed (please follow local regulatory requirements if the legal age of consent for study participation is \>18 years old)
  • +Pathologically documented HER2-expressing or HER2-mutated (activating mutation) solid tumor that is unresectable or metastatic
  • +Is willing and able to provide tumor tissue
  • +Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → assessment
  • +Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • +Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
  • +Has adequate organ and bone marrow function within 14 days before the start of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to Cycle 1 Day 1.
  • +Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
  • +Dose-escalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more → Phase:
  • +Has progressed or was non-responsive to available therapies and for which no standard or available anticancer therapy exists
  • +Has a pathologically documented HER2-expressing or HER2-mutated solid tumor
  • +Dose-expansion Phase:
  • +Has pathologically documented specific HER2 altered advanced solid tumor type
  • +Has received prior therapy as specified in the protocolProtocolThe detailed plan a study must follow.Read more →
  • +A woman of childbearing potential (WOCBP) is eligible to participate if she is not pregnant as confirmed by highly sensitive pregnancy test and agrees to adhere to a contraceptive method that is highly effective during the Treatment Period and for at least the time needed to eliminate each study drug after the last dose.
  • +A male participant capable of producing sperm is eligible to participate if he agrees to adhere to the contraception methods as specified in the protocol and avoids donating sperm during the Treatment Period and for at least the time needed to eliminate each study drug.

Exclusion

  • Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products or other monoclonal antibodies
  • Has active or uncontrolled human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and CD4 count.
  • Has active or uncontrolled HBV or HCV. Hepatitis B and C screeningScreeningThe checks done before joining, to see whether a study fits.Read more → testing is required. Participants are eligible only if they meet criteria as specified in the protocolProtocolThe detailed plan a study must follow.Read more →.
  • Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy.
  • Has an inadequate treatment washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → prior to start of study treatment as specified in the protocol
  • Medical history of myocardial infarction (MI) within 6 months before study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class II to IV
  • Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \>470 ms (females) or \>450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
  • Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to controlControl groupThe group a new treatment is measured against.Read more → associated symptoms
  • Has multiple primary malignancies within 3 years. Exceptions are specified in the protocol.
  • Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
  • Is requiring concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications during the study
  • Has received a live, attenuated vaccine (messenger ribonucleic acid \[mRNA\] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug(s)
  • Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.
  • Has unresolved toxicities from previous anticancer therapy
  • Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder
  • Any autoimmune, connective tissue or inflammatory disorders
  • Prior complete pneumonectomy
  • Any of the following within 6 months of enrollment: Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolism event
  • Psychological, social, familial, or geographical factors that would prevent regular follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →
  • Any active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy
  • Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) and/or severe arrhythmia within 28 days before enrollment
  • Female who is pregnant, breastfeeding, or planning to become pregnant
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 3 groups in this study.

Groups A, B and C receive DS-1103a and T-DXd.

Registry label: A: Dose Escalation: DS-1103a + T-DXd · B: Dose Expansion (Cohort 1): DS-1103a + T-DXd · C: Dose Expansion (Cohort 2): DS-1103a + T-DXd

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 108 people.

The study is currently expected to finish around May 2030.

The main measurement is taken over: From Cycle 1 Day 1 to Cycle 2 Day 21 (each cycle is 21 days).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Number of Participants with Dose-limiting Toxicities (Dose EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more →) — measured over From Cycle 1 Day 1 to Cycle 2 Day 21 (each cycle is 21 days).

Number of Participants with Dose-limiting Toxicities Following DS-1103a Combination Therapy (Dose Expansion; CohortCohortA group of participants sharing a characteristic, followed together.Read more → 2) — measured over From Cycle 1 Day 1 to Cycle 1 Day 21 (each cycle is 21 days).

Overall Number of Participants With Treatment-emergent Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → and Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (Dose Escalation and Dose Expansion) — measured over ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → through long-term follow upFollow-upContinued check-ins after the treatment part is finished.Read more →, up to approximately 91 months.

Objective Response Rate Assessed by Blinded Independent Central Review Following DS-1103a Combination Therapy (Dose Expansion) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Dose Expansion) up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years 11 months.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05765851 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About DS-1103aDrug

One IV infusion Q3W on Day 1 of each 21-day cycle

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About T-DXdDrug

One IV infusion Q3W on Day 1 of each 21-day cycle

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: From Cycle 1 Day 1 to Cycle 2 Day 21 (each cycle is 21 days).

The study as a whole is currently expected to finish around 2030-05-15.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 108 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.