Phase 1: testing DS-1103a for Advanced Solid Tumor
This study will measure the safety and how well it works of DS-1103a combination therapy in participants with advanced solid tumors.
Official registry: https://clinicaltrials.gov/study/NCT05765851 · Daiichi Sankyo · enrollment listed as 128
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are DS-1103a, or T-DXd. The registry lists allocation as randomized. This study will measure the safety and how well it works of DS-1103a combination therapy in participants with advanced solid tumors.
They plan to enroll about 128 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: DS-1103a, T-DXd
Primary outcome (registry wording): Number of Participants with Dose-limiting Toxicities (Dose Escalation)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- 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 investigator 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 enrollment
- 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
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
Who the registry excludes
- 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)
- 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 control associated symptoms
- Has multiple primary malignancies within 3 years. Exceptions are specified in the protocol
Public study contact (from the registry)
Contact for Clinical Trial Information
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
15 listed- Florida Cancer Specialists — Sarasota, Florida (recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York (recruiting)
- Lifespan Cancer Institute — Providence, Rhode Island (recruiting)
- University of Utah — Salt Lake City, Utah (recruiting)
- NEXT Oncology — Fairfax, Virginia (recruiting)
+ 10 sites outside the US on the same record
FAQ about this NCT record
Is NCT05765851 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05765851?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05765851?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary