Clinical trial NCT02004717: Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors
Official title: Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-8895a in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: advanced solid tumor
Phase 1
Oncology
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
* Eastern Cooperative Oncology Group performance status(PS) of 0 or 1

Exclusion Criteria:

* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia)

* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases defined as symptomatic or requiring treatment.

Primary outcomes:
measure: number of participants experiencing dose limiting toxicities
timeFrame: day 1 through day 28
measure: number of participants experiencing clinical or laboratory adverse events
timeFrame: from start of treatment to end of treatment, on expected average 12 weeks
measure: serum pharmacokinetics of DS-8895a
timeFrame: Cycle 1 - days 1, 2, 4, 8 and 15; Cycle 2-days 1, 2, 4, 8 and 15; Cycle 3 and on- days 1; end of study; 45 days post last dose
Secondary outcomes:
measure: level of anti-DS-8895a (HAHA) antibody
timeFrame: Cycle 1 days 1 and 15; Cycle 2 day 1; end of study; 45 days post-last-dose
measure: disease control rate
timeFrame: every 6 weeks
measure: pharmacodynamic effects in blood
timeFrame: day 1 and 2
measure: pharmacodynamic effects in tumors
timeFrame: baseline and day 1 of cycle 2
measure: objective response rate
timeFrame: every 6 weeks
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
References:
citation: Shitara K, Satoh T, Iwasa S, Yamaguchi K, Muro K, Komatsu Y, Nishina T, Esaki T, Hasegawa J, Kakurai Y, Kamiyama E, Nakata T, Nakamura K, Sakaki H, Hyodo I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors. J Immunother Cancer. 2019 Aug 14;7(1):219. doi: 10.1186/s40425-019-0679-9.