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Safety of ADU-1604 in Adults With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT03674502
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Brief Summary:
This study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, PK, and PD of ADU-1604 and explore initial clinical activity in adults with metastatic melanoma.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: ADU-1604 Phase 1

Detailed Description:

ADU-CL-17 is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ADU-1604, an anti-CTLA-4 monoclonal antibody, and explore initial clinical activity in adults with metastatic melanoma. The primary objective of the study is to determine the Recommended Phase 2 Dose (RP2D) of ADU-1604 administered by IV infusion once every 3 weeks for 4 doses.

The study will be conducted in two parts: Dose Escalation followed by Dose Confirmation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 29, 2020
Estimated Study Completion Date : September 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: ADU-1604
ADU-1604 administered as an IV infusion
Drug: ADU-1604
anti-CTLA-4 monoclonal antibody




Primary Outcome Measures :
  1. Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female aged ≥18 years
  2. Histologically-confirmed metastatic or unresectable melanoma
  3. Progression of disease following at least one prior therapy, and is not a candidate for, or is intolerant to, established therapy known to provide clinical benefit (i.e. available treatment options have been exhausted). Subjects must have BRAF mutation status confirmed; if a subject is BRAF V600E/K positive, they must have received a BRAF- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment
  4. Measurable disease according to RECIST (v1.1) [NOT required during Dose Escalation]
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

  1. Prior diagnosis of uveal or mucosal melanoma
  2. Prior treatment with CTLA-4-directed therapy in the metastatic setting. Use of CTLA- 4-directed treatment in the adjuvant or neoadjuvant setting is acceptable provided the last dose was >6 months before the first dose of ADU-1604 and there was no discontinuation of treatment due to a treatment-related toxicity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674502


Locations
France
Hôpital de la Timone Recruiting
Marseille, France, 13885
Contact: Annick Pelletier, MD    +33 4 91 38 46 44    annick.pelletier@ap-hm.fr   
Principal Investigator: Jean-Jacques Grob, MD         
Hospital Saint Louis Recruiting
Paris, France, 75010
Contact: Celeste Lebbe, MD, PhD    +33 1 42 49 93 92    celeste.lebbe@aphp.fr   
Principal Investigator: Celeste Lebbe, MD, PhD         
Gustave- Roussy Institute Recruiting
Villejuif, France, 94805
Contact: Caroline Robert, MD    +33 14211 4210    caroline.robert@gustaveroussy.fr   
Principal Investigator: Caroline Robert, MD         
Spain
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Ainara Soria, MD    +34 917878600    ainarasoria@hotmail.com   
Principal Investigator: Ainara Soria, MD         
Hospital Universitario Virgen Macarena Recruiting
Seville, Spain, 41009
Contact: Maria Luisa Sanchez    +34 671592620    oncomacarena@gmail.com   
Principal Investigator: Luis De la Cruz Merino, MD         
Sponsors and Collaborators
Aduro Biotech, Inc.

Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03674502     History of Changes
Other Study ID Numbers: ADU-CL-17
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas