Description:
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.
Title
- Brief Title: A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
- 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 IDs
- ORG STUDY ID:
DS1055-A-J101
- NCT ID:
NCT04419532
Conditions
- Solid Tumor
- Advanced Cancer
- Metastatic Solid Tumor
Interventions
Drug | Synonyms | Arms |
---|
DS-1055a | | Dose Escalation (DS-1055a) |
Purpose
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.
Detailed 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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
Inclusion Criteria:
- Has a histopathologically documented locally advanced or metastatic head and neck,
gastric, or esophageal cancer, or the other types of solid tumors.
- Has a relapsed or refractory disease that is not amenable to curative standard
therapy.
- Is 18 years of age or older (or complies with country-specific regulatory
requirements, at least 20 years of age in Japan).
- 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with dose-limiting toxicities |
Time Frame: | 21 days of Cycle 1 |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Maximum Serum Concentration (Cmax) |
Time Frame: | 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) |
Safety Issue: | |
Description: | |
Measure: | Time to Reach Maximum Serum Concentration (Tmax) |
Time Frame: | 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) |
Safety Issue: | |
Description: | |
Measure: | Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau) |
Time Frame: | 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) |
Safety Issue: | |
Description: | |
Measure: | Minimum Observed Concentration (Ctrough) |
Time Frame: | 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) |
Safety Issue: | |
Description: | |
Measure: | The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies |
Time Frame: | From pre-treatment to follow-up visit (within approximately 2 years) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- Solid Tumor
- Advanced Cancer
- Metastatic Solid Tumor
- DS-1055a
Last Updated
August 11, 2021