A Phase 1, First In Human Study of DS-1055a in Subjects With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Daiichi Sankyo
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- Number of participants with dose-limiting toxicities
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
Dose Escalation (DS-1055a)
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.
Intervention: DS-1055a (Drug)
Outcomes
Primary Outcomes
Number of participants with dose-limiting toxicities
Time Frame: 21 days of Cycle 1
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.
Number of participants with adverse events
Time Frame: Baseline up to approximately 3 years
Adverse events were assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
Secondary Outcomes
- 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))
- 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))
- The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies(From pre-treatment to follow-up visit (within approximately 2 years))