A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

NCT04419532 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: DS1055-A-J101
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced or metastatic solid tumors for which no standard treatment is available.

Conditions

Solid Tumor; Advanced Cancer; Metastatic Solid Tumor

Keywords

Solid Tumor; Advanced Cancer; Metastatic Solid Tumor; DS-1055a

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose-limiting toxicities

  A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) that occurs during the DLT evaluation period (21 days), excluding toxicities clearly related to disease progression or intercurrent illness or to concomitant medications or to concomitant procedures and is Grade 3 or above according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0, with certain specified exceptions.

  21 days of Cycle 1

• Number of participants with adverse events

  Adverse events were assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.

  Baseline up to approximately 3 years

Secondary Outcomes (5)

• Maximum Plasma Concentration (Cmax)

  Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

• Time to Reach Maximum Plasma Concentration (Tmax)

  Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

• Area Under the Plasma Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)

  Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

• Minimum Observed Concentration (Ctrough)

  Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)

• The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies

  From pre-treatment to follow-up visit (within approximately 2 years)

Study Arms (1)

Dose Escalation (DS-1055a)

EXPERIMENTAL

Participants will be enrolled into groups with each group receiving an increased dose from the previous group as safety assessments permit in order to determine the optimal dose for safety and tolerability.

Drug: DS-1055a

Interventions

DS-1055a DRUG

Administered as an intravenous infusion on Day 1 of every 21-day cycle following low dose administration(s) in priming dose period. Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions

Dose Escalation (DS-1055a)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a histopathologically documented locally advanced or metastatic head and neck, gastric, esophageal cancer, non-small cell lung cancer, or melanoma. Participants with other types of solid tumors may be eligible following discussion with the Sponsor.
• Has a relapsed or refractory disease that is not amenable to curative standard therapy.
• Is 18 years of age or older.
• Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, with no deterioration for two weeks.
• Has a measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Has adequate organ function within 7 days before enrollment.
• Is able to provide written informed consent and is willing and able to comply with the protocol.

You may not qualify if:

• Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants with history of the second malignancy have been disease-free for \<3 years.
• Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.
• Has a history of severe pulmonary compromise or requirement of supplemental oxygen within 6 months before enrollment.
• Has active hepatitis B or hepatitis C virus infection.
• Has received prior immunotherapy with a Grade 3 or higher, or any unresolved ≥Grade 2 immune-related adverse event.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (6)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45219, United States

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2C1, Canada

Location

National Cancer Center Hospital

Chūōku, 104-0045, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

Location

Cancer Institute Hospital of JFCR

Kōtoku, 135-8550, Japan

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: October 9, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

JP (3); CA (1); US (2)