General information
  • Disease category Colon and Rectal Cancer , Lung Cancer , Melanoma (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Bellinzona, St. Gallen
    (BASEC)
  • Contact Martina Imbimbo martina.imbimbo@eoc.ch (BASEC)
  • Data Source(s) BASEC: Import from 12.05.2025 ICTRP: N/A
  • Last update 12.05.2025 16:10
HumRes66117 | SNCTP000006184 | BASEC2024-D0095

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.

  • Disease category Colon and Rectal Cancer , Lung Cancer , Melanoma (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Bellinzona, St. Gallen
    (BASEC)
  • Contact Martina Imbimbo martina.imbimbo@eoc.ch (BASEC)
  • Data Source(s) BASEC: Import from 12.05.2025 ICTRP: N/A
  • Last update 12.05.2025 16:10

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. Approximately 485 participants will be enrolled in the study.

(BASEC)

Intervention under investigation

AMG 355 is a drug that aims 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)

Criteria for participation in trial
Participants must be at least 18 years old and have histologically or cytologically confirmed metastatic or locally advanced solid tumors that have recurred and/or not responded to established and available therapies with known clinical benefit, or are unsuitable for these. This includes participants with non-small cell lung cancer (NSCLC), colorectal adenocarcinoma (CRC), gastric adenocarcinoma (GC), and melanoma. Patients with CRC must have microsatellite stable (MSS) disease. Participants must have an estimated life expectancy of at least 3 months, as assessed by the study physician, and 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, among others, untreated or symptomatic metastases in the central nervous system, prior T-cell receptor-targeted therapies 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 simultaneously in another clinical trial. These criteria are designed to ensure that the study is as safe as possible for participants and that the results of the study are meaningful. (BASEC)

Trial sites

Bellinzona, St. Gallen

(BASEC)

not available

Sponsor

AMGEN Switzerland

(BASEC)

Contact

Contact Person Switzerland

Martina Imbimbo

+41 91 811 89 31

martina.imbimbo@eoc.ch

Ente Ospedaliero Cantonale (EOC) Istituto Oncologico della Svizzera italiana (IOSI)-Ospedale San Giovanni (ORBV), Via A. Gallino 12, CH-6500 Bellinzona

(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

20.11.2024

(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
not available

Public title
not available

Disease under investigation
not available

Intervention under investigation
not available

Type of trial
not available

Trial design
not available

Inclusion/Exclusion criteria
not available

not available

Primary and secondary end points
not available

not available

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
not available

Secondary trial IDs
not available

Results-Individual Participant Data (IPD)
not available

Further information on the trial
not available


Results of the trial

Results summary

not available

Link to the results in the primary register

not available