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A Study of DS5361b in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only).

Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and/or MSI-H status. In Part 3, participants need to have documented TMB-H status.

Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.

Disqualifiers

Has spinal cord compression or clinically active central nervous system metastases.

Has a history of leptomeningeal carcinomatosis.

Uncontrolled or significant cardiovascular disease.

Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.

Trial design

Design model

Single group

Treatments tested in this trial

  • DS5361b

    Drug

    Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE. Dose Expansion Part: DS5361b will be administered at RDE.

  • Pembrolizumab

    Drug

    Dose Escalation Part: Pembrolizumab will be administered at a standard dose. Dose Expansion Part: Pembrolizumab will be administered at a standard dose.

Treatment groups

192 Participants
are divided into 3 treatment groups
Group A: Part 1: Monotherapy (Dose Escalation)Experimental treatment 1 intervention
Group B: Part 2: Combination Therapy (Dose Escalation)Experimental treatment 2 interventions
Group C: Part 3: Combination Therapy (Dose Expansion)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs)

A DLT is defined as any Treatment Emergent Adverse Event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc, that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3.

Time frame
Cycle 1: Day 1 up to Day 21 (each cycle is 21 days)
2

Part 1, 2, and 3: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)

TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).

Time frame
From Screening up to approximately 5 years
3

Part 3 Only: Objective Response Rate (ORR) Following the Administration of DS5361b at RDE(s) in Combination with Pembrolizumab

ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1.

Time frame
From first dose up to approximately 5 years

Secondary outcomes

1

Maximum Plasma Concentration (Cmax) of DS5361b

Time frame
Cycle 1: Day 1, Day 15 (each cycle is 21 days)
2

Time to Reach Maximum Plasma Concentration (Tmax) of DS5361b

Time frame
Cycle 1: Day 1, Day 15 (each cycle is 21 days)
3

Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) of DS5361b

Time frame
Cycle 1: Day 1 (each cycle is 21 days)
4

Trough Plasma Concentration (Ctrough) of DS5361b

Time frame
Cycle 1: Day 15 (each cycle is 21 days)

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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