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DS-1103a

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 11, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

DS-1103a · 1 trial · 1 indication

Phase 1 1
NCT05765851A Study of DS-1103a Combination Therapy in Participants With Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING108 Analytics
PHASE1RECRUITING
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Dose-limiting Toxicities (Dose Escalation)
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; Cohort 2)
From Cycle 1 Day 1 to Cycle 1 Day 21 (each cycle is 21 days)
Overall Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Dose Escalation and Dose Expansion)
Screening through long-term follow up, up to approximately 91 months
Objective Response Rate Assessed by Blinded Independent Central Review Following DS-1103a Combination Therapy (Dose Expansion)
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

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.

Secondary Endpoints

Objective Response Rate Assessed by Investigator (Dose Escalation and Dose Expansion)
Baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 91 months
Disease Control Rate Assessed by Investigator (Dose Escalation and Dose Expansion) and Blinded Independent Central Review (Dose Expansion)
Baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 91 months
Clinical Benefit Rate Assessed by Investigator (Dose Escalation and Dose Expansion) and Blinded Independent Central Review (Dose Expansion)
Baseline up until documented progressive disease, unacceptable toxicity, death, lost to follow-up, or withdrawal by the participant, up to approximately 91 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation: DS-1103a + T-DXdEXPERIMENTALParticipants with HER2-expressing or HER2-mutated advanced metastatic solid tumors who will receive an escalating intravenous (IV) infusion of DS-1103a (starting dose of 100 mg) every 3 weeks (Q3W) starting on Cycle 1 Day 1. Starting on Cycle 2 Day 1 and on Day 1 of each subsequent cycle, participants will also receive T-DXd IV Q3W.
Dose Expansion (Cohort 1): DS-1103a + T-DXdEXPERIMENTALParticipants with a specific HER2-altered advanced solid tumor type who will receive an IV infusion of DS-1103a at the recommended dose for expansion (RDE) in combination with T-DXd IV Q3W starting on Cycle 1 Day 1.
Dose Expansion (Cohort 2): DS-1103a + T-DXdEXPERIMENTALParticipants with a specific HER2-altered advanced solid tumor type who will receive an IV infusion of DS-1103a at the recommended dose for expansion (RDE) in combination with T-DXd IV Q3W starting on Cycle 1 Day 1.

Interventions

NameTypeDescription
DS-1103aDRUGOne IV infusion Q3W on Day 1 of each 21-day cycle
T-DXdDRUGOne IV infusion Q3W on Day 1 of each 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * 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 yea...

Countries:United StatesCanadaFranceSpain
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about DS-1103a

What is DS-1103a used for?

DS-1103a is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in patients.

Who makes DS-1103a?

DS-1103a is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate this investigational drug candidate for the treatment of advanced solid tumors.

What phase is DS-1103a in?

DS-1103a is currently in Phase 1 clinical development. This is an early stage of testing in humans, focused on evaluating the drug's safety, tolerability, and preliminary efficacy. The drug is investigational and has not yet received regulatory approval for any indication.

What clinical trials is DS-1103a in?

DS-1103a is being studied in a Phase 1 clinical trial with the identifier NCT05765851. This trial is titled 'A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors' and is currently recruiting participants in the United States, Canada, France, and Spain.

Is DS-1103a being studied as a monotherapy or combination therapy?

DS-1103a is being studied as a combination therapy in its current clinical trial. The Phase 1 study, NCT05765851, is evaluating DS-1103a in combination with other agents in participants with advanced solid tumors. The trial is a controlled study, though it is not randomized or double-blinded.

Does the DS-1103a clinical trial use biomarkers?

Yes, the DS-1103a clinical trial is biomarker-selected. This means that the study may enroll patients based on specific biomarkers, which could help identify individuals who are more likely to respond to the treatment. The trial is currently recruiting participants with advanced solid tumors.