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First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

NCT03401385 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 890

Last updated 2025-10-21

No results posted yet for this study

Summary

This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study.

The primary purpose of the parts are:

* Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a
* Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors

This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan.

The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:

* they withdraw
* their disease gets worse
* they experience unacceptable side effects.

The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a.

The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part.

Conditions

Interventions

DRUG

Datopotamab Deruxtecan (Dato-DXd)

A total anti-TROP2 antibody and MAAA-1181a

DRUG

Steroid Containing Mouthwash

A mouthwash containing a steroid ingredient administered in sub-study

OTHER

Non-Steroid Containing Mouthwash

A mouthwash containing a non-steroid ingredient administered in sub-study

Sponsors & Collaborators

Principal Investigators

  • Global Team Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401385 on ClinicalTrials.gov