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

Solid Tumor Clinical Trial

Official title:

A Phase 1, First In Human Study of DS-1055a in Subjects With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04419532
• Other study ID #: DS1055-A-J101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 9, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Daiichi Sankyo
• Contact: (Asia sites) Daiichi Sankyo Contact for Clinical Trial Informati
• Phone: +81-3-6225-1111(M-F 9-5 JST)
• Email: dsclinicaltrial[@]daiichisankyo.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a, pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs) against DS-1055a and other antibodies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Solid Tumor
• Neoplasms
• Solid Tumor

Intervention

Drug:
• DS-1055a
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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Japan	National Cancer Center Hospital	Chuo Ku
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Cancer Institute Hospital of JFCR	Koto-Ku
United States	University of Cincinnati Cancer Center	Cincinnati	Ohio
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies		From pre-treatment to follow-up visit (within approximately 2 years)