Safety of ADU-1604 in Adults With Metastatic Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03674502 |
Recruitment Status :
Recruiting
First Posted : September 17, 2018
Last Update Posted : December 10, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Melanoma | Drug: ADU-1604 | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: ADU-1604
ADU-1604 administered as an IV infusion
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Drug: ADU-1604
anti-CTLA-4 monoclonal antibody |
- Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion [ Time Frame: 9 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female aged ≥18 years
- Histologically-confirmed metastatic or unresectable melanoma
- 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
- Measurable disease according to RECIST (v1.1) [NOT required during Dose Escalation]
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
- Prior diagnosis of uveal or mucosal melanoma
- 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.

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
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 |
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 |