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A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0010718C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0010718C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications


Inclusion Criteria:



- Signed written informed consent

- Male or female subjects aged greater than or equal to 18 years

- Histologically or cytologically proven metastatic or locally advanced solid tumors,
for which no standard therapy exists or standard therapy has failed

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry
and an estimated life expectancy of at least 3 months

- Disease must be measurable with at least 1 uni-dimensional measurable lesion by
RECIST 1.1

- Adequate hepatic function as defined in the protocol

- Adequate renal function defined by an estimated creatinine clearance greater than 50
milliliter per minute (mL/min) according to the Cockcroft-Gault formula

- Effective contraception for both male and female subjects if the risk of conception
exists

- Other inclusion criteria apply

Exclusion Criteria:

- Concurrent treatment with a non-permitted drug

- Prior therapy with specific antibody/drug targeting T cell co-regulatory proteins
(immune checkpoints)

- Concurrent anticancer treatment concurrent systemic therapy with steroids or other
immunosuppressive agents, or use of any investigational drug within 30 days before
the start of trial treatment. Short-term administration of steroids (that is, for
allergic reactions or the management of immune-related adverse events [irAE]) is
allowed

- Previous malignant disease within the last 5 years with the exception of basal or
squamous cell carcinoma of the skin or cervical carcinoma in situ

- Pregnancy or lactation period

- Known alcohol or drug abuse

- Clinically significant (that is, active) cardiovascular disease

- All other significant diseases (for example, inflammatory bowel disease), which, in
the opinion of the investigator, might impair the subject's tolerance of trial
treatment

- Any psychiatric condition that would prohibit the understanding or rendering of
informed consent

- Legal incapacity or limited legal capacity

- Other exclusion criteria apply

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity

Outcome Time Frame:

Up to 3 weeks

Safety Issue:

Yes

Principal Investigator

Medical Direcor

Investigator Role:

Study Director

Investigator Affiliation:

EMD Serono Inc.

Authority:

United States: Food and Drug Administration

Study ID:

EMR 100070-001

NCT ID:

NCT01772004

Start Date:

January 2013

Completion Date:

December 2016

Related Keywords:

  • Solid Tumors
  • Solid Tumors
  • MSB0010718C
  • Phase 1
  • Pharmacokinetic
  • Neoplasms

Name

Location

Contact US Medical Information for US Recruiting SitesRockland, Massachusetts