A study to evaluate a new drug called AMG 355, administered alone or in combination with another drug, Pembrolizumab, in patients with advanced cancers, to assess its safety and efficacy.
Summary description of the study
This is a multicenter, open-label phase 1 study conducted in two treatment groups. In the first group, participants receive AMG 355 as monotherapy, and in the second group, AMG 355 is administered in combination with Pembrolizumab. The study consists of three parts: dose escalation, dose confirmation, and dose expansion, to characterize safety and preliminary efficacy in larger populations. A total of approximately 485 participants will be enrolled in the study.
(BASEC)
Intervention under investigation
AMG 355 is a drug designed to enhance the immune system by targeting certain immune cells in the tumor, known as regulatory T cells. This may allow the immune system to act more actively against the cancer and fight it more effectively. Participants receive either AMG 355 as a single treatment or in combination with Pembrolizumab. The study is divided into three parts per treatment group: in the first part, the dose of AMG 355 is gradually increased to test its safety and tolerability. In the second and third parts, the optimal dose is confirmed and the efficacy of the drug is investigated in a larger group of patients with certain advanced cancers.
(BASEC)
Disease under investigation
The study involves the treatment of patients with advanced solid tumors, including non-small cell lung cancer, colorectal cancer, gastric cancer, and melanoma.
(BASEC)
Participants must be at least 18 years old and have histologically or cytologically confirmed metastatic or locally advanced solid tumors that have either recurred and/or not responded to established and available therapies with known clinical benefit, or are unsuitable for these therapies. This includes participants with non-small cell lung cancer (NSCLC), colorectal adenocarcinoma (CRC), gastric adenocarcinoma (GC), and melanoma. Patients with CRC must have a microsatellite stable (MSS) disease. Participants must have, in the opinion of the study physician, an expected survival of at least 3 months, as well as an ECOG (Eastern Cooperative Oncology Group) status of 0 or 1. They must also be willing to undergo at least one biopsy. (BASEC)
Exclusion criteria
Medical conditions or treatment histories that preclude participation in the study include, but are not limited to, untreated or symptomatic metastases in the central nervous system, prior therapies targeting T-cell receptors that were discontinued due to immune-related side effects, known allergic reactions to antibody therapies, use of immunosuppressants, autoimmune diseases, active infections, prior organ transplants, as well as the use of certain medications that may interact with the study treatment. It is also important that patients do not participate in another clinical study simultaneously. These criteria are intended to ensure that the study is as safe as possible for participants and that the study results are meaningful. (BASEC)
Trial sites
Bellinzona, St. Gallen
(BASEC)
Sponsor
Amgen Switzerland
(BASEC)
Contact
Contact Person Switzerland
Martina Imbimbo
+41 91 811 89 31
martina.imbimbo@cluttereoc.chIstituto Oncologico della Svizzera Italiana
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Ticino
(BASEC)
Date of authorisation
30.08.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available