Health TrialsbyHealthPanel

First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors

ConditionsSolid TumorsSarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign and date the main ICF.

Adults ≥18 years at the time the biosample ICF or main ICF, whichever is signed first.

Relapsed from, refractory to, or intolerant to appropriate therapies [eg, standard of care (SOC) therapy] to provide clinical benefit for their condition as assessed by their physician and/or investigator. [For South Korea only: Relapsed from, refractory to, or intolerant to all available therapies (eg, SOC therapy domestically approved) for their condition.]

HLA-A*02:01, 02:02, 02:03, 02:04, 02:05, 02:06, 02:09, 02:10, or 02:11 positive.

Disqualifiers

Has received prior therapy targeting NY-ESO-1.

Radiation therapy: <4 weeks (or <2 weeks if palliative radiation therapy without abdominal/pelvic radiation)

Chemotherapy, antibody-based anticancer therapy, immunotherapy: <4 weeks

Small molecules (eg, tyrosine kinase inhibitors): <2 weeks or 5 half-lives, whichever is longer

Trial design

Design model

Sequential

Treatments tested in this trial

  • DS-2243a

    Drug

    Escalation Part: DS-2243a will be administered at escalating doses to determine the RDE Expansion Part: DS-2243a will be administered at RDE

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: Part 1: Dose Escalation DS-2243aExperimental treatment 1 intervention
Group B: Part 2: Dose Expansion SS/MRCLSExperimental treatment 1 intervention
Group C: Part 2: Dose Expansion Sq-NSCLCExperimental treatment 1 intervention
Group D: Part 2: Dose Expansion UCExperimental treatment 1 intervention
Group E: Part 2: Dose Expansion Ad-NSCLCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of participants with Dose-Limiting Toxicities at each dose level of DS-2243a

Time frame
Up to 18 months
2

Part 2: Number of participants with Treatment-Emergent Adverse Events

Descriptive statistics of treatment-emergent adverse events (TEAEs)

Time frame
Up to 3 years
3

Part 2: Objective Response Rate

Objective Response Rate (ORR) as assessed by the investigator according to RECIST v1.1.

Time frame
From day of first dose up to 3 years

Secondary outcomes

1

Part 1: Objective Response Rate

ORR as assessed by the investigator according to RECIST v1.1.

Time frame
From day of first dose up to 3 years
2

Disease Control Rate

Disease Control Rate (DCR) as assessed by the investigator according to RECIST v1.1.

Time frame
From day of first dose up to 4 years.
3

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) as assessed by the investigator according to RECIST v1.1.

Time frame
From day of first dose up to 4 years
4

Overall Survival

Time frame
From day of first dose up to 4 years

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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