Health Trials

First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors

ConditionsAdvanced Solid TumorMetastatic Solid TumorUnresectable Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign and date the main ICF, prior to the start of any trial-specific 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 trial participation is >18 years old).

Histologically documented, advanced, metastatic, or unresectable solid tumors.

Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • DS1025a

    Drug

    Administered on Day 1

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Dose Escalation: DS1025aExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants Reporting Dose-limiting Toxicities (DLTs)

Time frame
Day 1 up to approximately 12 months
2

Number of Participants Reporting Adverse Events (AEs)

Time frame
Screening up to long-term survival follow up every 12 weeks, up to approximately 12 months
3

Number of Participants Reporting Discontinuation of DS1025a Due to AEs

Time frame
Screening up to long-term survival follow up every 12 weeks, up to approximately 12 months

Secondary outcomes

1

Pharmacokinetic Parameter Area Under the Plasma-Concentration Curve (AUC)

Area under the curve over the dosing interval (AUCtau) and Area under the plasma concentration-time curve up to the last quantifiable time (AUClast) will be assessed.

Time frame
Predose up to approximately 12 months
2

Pharmacokinetic Parameter Maximum Concentration (Cmax)

Time frame
Predose up to approximately 12 months
3

Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)

Time frame
Predose up to approximately 12 months
4

Pharmacokinetic Parameter Concentration at Trough Level (Ctrough)

Time frame
Predose up to approximately 12 months

Other outcomes

Sponsors and contacts

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

Daiichi Sankyo

Lead sponsor

Source ClinicalTrials.gov
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