Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Trastuzumab deruxtecan

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

Participants with HER2-expressing or HER2-mutant advanced metastatic solid tumors who will receive an 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 Q3W at a dose of 5.4 mg/kg.

Participants with HER2-low expressing breast cancer who will receive an IV infusion of DS-1103a at the recommended dose for expansion (RDE) in combination with T-DXd 5.4 mg/kg Q3W starting on Cycle 1 Day 1.

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

DS-1103a

T-DXd

Contact for Clinical Trial Information

Principal Investigator

Global Clinical Leader

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

DS-1103a, a recombinant humanized IgG4 anti-SIRPα antibody designed to block the SIRPα-CD47 interaction, is being developed for the treatment of advanced cancers in combination with other anticancer therapies. This is the first-in-human, dose-escalating clinical study designed to assess the safety and efficacy of DS-1103a combination therapy in patients with advanced solid tumors.

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

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on blinded independent central review (BICR) by Response Evaluation Criteria In Solid Tumors v1.1 and confirmed by a second assessment.

Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator (Response Evaluation Criteria In Solid Tumors v1.1) and confirmed by a second assessment.

Disease control rate is defined as the sum of the CR rate, PR rate, and stable disease (SD) rate based on investigator assessment (Dose Escalation) or blinded independent central review (BICR)(Dose Expansion).

Clinical benefit rate (CBR) is defined as the sum of the CR rate, PR rate, and ≥6 months SD rate based on investigator assessment (Dose Escalation) or BICR (Dose Expansion).

Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) (based on investigator assessment \[Dose Escalation\] or blinded independent central review (BICR) \[Dose Expansion\]) or death. The DoR will be calculated for responding participants (PR or CR) only.

Area under the plasma concentration-time curve up to the last quantifiable time (AUClast) and Area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed using non-compartmental methods.

Maximum plasma concentration (Cmax) will be assessed using non-compartmental methods.

Time to maximum plasma concentration (Tmax) will be assessed using non-compartmental methods.

Minimum plasma concentration (Cmin) will be assessed using non-compartmental methods.

Spots Global Cancer Trial Database for A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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