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.

AstraZeneca

Daiichi Sankyo

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pembrolizumab

Cetuximab

Immune Checkpoint Inhibitors

Evorpacept (ALX148) + cetuximab + pembrolizumab. Evorpacept (ALX148) 15 mg/kg IV weekly, cetuximab 400 mg/m2 once then 250 mg/m2 weekly, and pembrolizumab 200 mg every 3 weeks

Evorpacept (ALX148)

Robert Lentz, MD

This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer

This is an open-label, multi-center, single-arm phase II clinical trial (with safety run-in) evaluating the combination of evorpacept (ALX148), cetuximab, and pembrolizumab in patients with metastatic microsatellite stable colorectal cancer who have progressed on at least 2 lines of systemic therapy. A subset of patients will undergo study-related biopsies. There will be a safety run-in stage followed by a dose expansion stage. Patients in both stages will continue to receive study therapy until disease progression according to RECIST v1.1.

A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer

A Phase II Study (With Safety run-in) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab in Patients With Refractory Microsatellite Stable Metastatic Colorectal Cancer

To determine the recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab

To determine the objective response rate (ORR), defined as partial response or complete response, with evorpacept (ALX148), cetuximab, and pembrolizumab using RECIST v1.1 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed on at least two lines of standard therapy

To determine the disease-control rate (DCR), defined as stable disease, partial response, or complete response with evorpacept (ALX148), cetuximab, and pembrolizumab using RECIST v1.1

To determine the duration of response (DOR) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from response (partial or complete) to progression

To determine the progression-free survival (PFS) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from enrollment to the first observation of progression using RECIST v1.1 or death from any cause

To determine the overall survival (OS) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from enrollment to death from any cause

To determine the first cycle dose-limiting toxicities (DLT) of evorpacept (ALX148), cetuximab, and pembrolizumab in stage 1

To evaluate the safety and tolerability of evorpacept (ALX148), cetuximab, and pembrolizumab, defined and graded according to the NCI CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors	NCT05765851	Advanced Solid ... Breast Cancer	DS-1103a T-DXd	18 Years -	Daiichi Sankyo
A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer	NCT05167409	Microsatellite ...	Evorpacept (ALX... Cetuximab Pembrolizumab	18 Years -	University of Colorado, Denver

Spots Global Cancer Trial Database for sirpa

Every month we try and update this database with for sirpa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sirpa

Every month we try and update this database with for sirpa cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sirpa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.