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

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign and date the informed consent form (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

Disqualifiers

Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy.

Has an inadequate treatment washout period prior to start of study treatment as specified in the protocol

Medical history of myocardial infarction (MI) within 6 months before study enrollment, 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)

Trial design

Design model

Single group

Treatments tested in this trial

  • DS-1103a

    Drug

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

  • T-DXd

    Drug

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

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: Dose Escalation: DS-1103a + T-DXdExperimental treatment 2 interventions
Group B: Dose Expansion (Cohort 1): DS-1103a + T-DXdExperimental treatment 2 interventions
Group C: Dose Expansion (Cohort 2): DS-1103a + T-DXdExperimental treatment 2 interventions
Group D: Dose Expansion (Cohort 3) DS-1103a + T-DXdExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Dose-limiting Toxicities (Dose Escalation)

Time frame
From Cycle 1 Day 1 to Cycle 2 Day 21 (each cycle is 21 days)
2

Objective Response Rate Assessed by Blinded Independent Central Review Following DS-1103a Combination Therapy (Dose Expansion)

Objective response rate (ORR) is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors v1.1.

Time frame
Baseline (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
3

Number of Participants with Dose-limiting Toxicities Following DS-1103a Combination Therapy (Dose Expansion; Cohort 2 Safety Run In and Japanese Population Tolerability Assessments)

Time frame
From Cycle 1 Day 1 to Cycle 1 Day 21 (each cycle is 21 days)
4

Overall Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Dose Escalation and Expansion; Cohort 2 Safety Run In and Japanese Population Tolerability Assessments)

Time frame
Screening through long-term follow up, up to approximately 91 months

Secondary outcomes

1

Overall Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Dose Expansion)

Time frame
Screening through long-term follow up, up to approximately 5 years 11 months
2

Objective Response Rate Assessed by Investigator (Dose Escalation and Dose Expansion)

Objective response rate (ORR) is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) as assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Time frame
Baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 91 months
3

Disease Control Rate Assessed by Investigator (Dose Escalation and Dose Expansion) and Blinded Independent Central Review (Dose Expansion)

Disease control rate is defined as the proportion of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) as assessed by the Investigator (Dose Escalation and Dose Expansion) and Blinded independent Central Review (BICR)(Dose Expansion) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Time frame
Baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 91 months
4

Clinical Benefit Rate Assessed by Investigator (Dose Escalation and Dose Expansion) and Blinded Independent Central Review (Dose Expansion)

Clinical benefit rate (CBR) is defined as the proportion of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) lasting ≥183 days as assessed by the Investigator (Dose Escalation and Dose Expansion) and Blinded Independent Central Review (BICR) (Dose Expansion) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

Time frame
Baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 91 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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