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Completed

NCT Number: NCT00836888

ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.

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Key information

Conditions

Malignant Solid Tumor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kanto Region, Kanto, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4538

Biological

1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Primary outcomes

  1. Cmax at Single Dose

    Time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

  2. AUClast at Single Dose

    Time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

  3. T1/2 at Single Dose

    Time frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

  4. Ceoi at Multiple Doses

    Time frame: day 15

    Ceoi：Serum concentrations immediately after the end of continuous administration

Secondary outcomes

  1. Best Overall Response

    Time frame: up to study completion, every 4 weeks in principle

    Response Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure.

    Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Feb 4, 2009
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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