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ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Malignant Solid Tumor

Thank you

Trial Information

ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors


Inclusion Criteria:



- Histological or cytological diagnosis of solid tumor with at least one measurable
lesion of ≥ 10mm.

- Tumor must be advanced or recurrent which is refractory to standard therapies or for
which no alternative, appropriate therapy exists.

- ECOG Performance Status of 0-1

- Life expectancy ≥ 3 months

- Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

- History of severe hypersensitivity reactions to other antibodies.

- Residual adverse reactions or effect of prior therapy, which deemed to affect the
safety evaluation of the study drug by the investigator or subinvestigator.

- Two or more synchronous tumors, except for adequately treated basal cell cancer or
cancer in situ, or superficial bladder cancer, or any other cancers from which the
patient has been disease-free for at least 5 years.

- Patients with any active autoimmune disease or a documented history of chronic or
recurrent autoimmune disease, or current medical condition that requires systemic
immunosuppressive doses of steroids or other immunosuppressive medications.

- Other exclusion criteria as specified in the study protocol

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the safety (adverse event, clinical laboratory test, vital sign measurement, 12-lead electrocardiography, chest X-ray, ECOG performance status)

Outcome Time Frame:

Up to study completion, every 2 weeks in principle

Safety Issue:

Yes

Principal Investigator

Ohyama Yukiya

Investigator Role:

Study Director

Investigator Affiliation:

Ono Pharmaceutical Co. Ltd

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

ONO-4538-01

NCT ID:

NCT00836888

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Malignant Solid Tumor
  • ONO-4538
  • MDX-1106
  • solid tumors
  • Neoplasms

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