Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors

NCT02004717 | Completed Phase 1

• 1 other identifier: DS8895-A-J101
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumors

Keywords

advanced solid tumor; Phase 1; Oncology

Outcome Measures

Primary Outcomes (3)

• number of participants experiencing dose limiting toxicities

  to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events

  day 1 through day 28

• number of participants experiencing clinical or laboratory adverse events

  to investigate the safety of DS-8895a reporting on frequency and seriousness of treatment emergent adverse events

  from start of treatment to end of treatment, on expected average 12 weeks

• serum pharmacokinetics of DS-8895a

  pharmacokinetics (Area Under the Curve-AUC, Terminal Elimination half-life-t1/2, Total Body Clearance) of DS-8895a in Japanese subjects with advanced solid tumors, and also to investigate the recommended dose of DS-8895a for subsequent clinical studies

  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 (5)

• level of anti-DS-8895a (HAHA) antibody

  Cycle 1 days 1 and 15; Cycle 2 day 1; end of study; 45 days post-last-dose

• disease control rate

  every 6 weeks

• pharmacodynamic effects in blood

  day 1 and 2

• pharmacodynamic effects in tumors

  baseline and day 1 of cycle 2

• objective response rate

  every 6 weeks

Study Arms (1)

dose escalation then expansion

EXPERIMENTAL

Dose escalation of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg. Six dose levels are planned: level 1,0.1 mg/kg; level 2,0.3 mg/kg; level 3, 1.0 mg/kg; level 4,3.0 mg/kg; level 5,10 mg/kg; level 6,20 mg/kg. Dose Expansion - Up to 20 subjects will be enrolled and treated at the dose determined in Dose Escalation arm.

Drug: DS-8895a

Interventions

DS-8895a DRUG

dose escalation then expansion

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (2)

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Related Publications (1)

• 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.

  PMID: 31412935 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)