Clinical trial NCT04419532: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Advanced Cancer
Metastatic Solid Tumor
Keywords: Solid Tumor
Advanced Cancer
Metastatic Solid Tumor
DS-1055a
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with dose-limiting toxicities
timeFrame: 21 days of Cycle 1
measure: Number of participants with adverse events
timeFrame: Baseline up to approximately 3 years
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 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)
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: 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)
measure: Area Under the Plasma Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)
timeFrame: 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)
measure: Minimum Observed Concentration (Ctrough)
timeFrame: 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)
measure: The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies
timeFrame: From pre-treatment to follow-up visit (within approximately 2 years)
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center
state: Ohio
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References: