[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

888-662-6728 (U.S. and Canada)

Email address

global-roche-genentech-trials@gene.com

Condition

Esophageal Squamous Cell Carcinoma,Metastatic Melanoma,Non-small Cell Lung Cancer,Solid Tumors

Treatment type

Interventional

Investigational product

RO7247669

Phase

Phase 1/Phase 2

Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT04140500

Study number

NP41300

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About the study

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of RO7247669, an anti PD-1 (programmed death-1) and LAG-3 (Lymphocyte-activation gene 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. This study aims to establish the maximum tolerated dose (MTD) and/or define the recommended phase 2 dose (RP2D) based on the safety, tolerability, pharmacokinetic (PK) and/or pharmacodynamic (PD) profile of RO7247669, and to evaluate preliminary anti-tumor activity in participants with solid tumors. An expansion part of the study is planned to enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RP2D of RO7247669 and to confirm safety and tolerability in participants with selected tumor types.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
  2. Eastern Cooperative Oncology Group Performance Status 0-1
  3. Fresh biopsies may be required
  4. Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol Additional Specific

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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