A Phase 2 Study of AMG 193 in Subjects With MTAP-deleted Advanced NSCLC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Apr 2025 → ongoing

Decision date (initial)

2025-03-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc.

External identifiers

EU CT number

2024-514459-14-00

WHO UTN

U1111-1311-4643

ClinicalTrials.gov

NCT06593522

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To characterize safety and efficacy of 2 dose levels of AMG 193 by investigator (Part 1 only)
To evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR)
(Part 1 and Part 2)

Secondary objectives 6

1. To evaluate other measures of AMG 193 anti-tumor activity by BICR
2. To evaluate other measures of anti-tumor activity of AMG 193 by investigator
3. To evaluate Overall Survival (OS)
4. To assess safety and tolerability of AMG 193
5. To evaluate the PK of AMG 193
6. To explore the subject experience with AMG 193 treatment using subject-reported outcome instruments

Conditions and MedDRA coding

Non-Small Cell Lung Cancer

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT06593522)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer.
2. Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
3. Either an archival tissue sample or an archival block must be available.
4. Life expectancy of greater than 3 months, in the opinion of the investigator.
5. Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
6. Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.

Exclusion criteria 3

1. Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).
2. Major surgery within 28 days of study day 1.
3. Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
2. Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs)
3. Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC)
4. OR (CR and PR) per RECIST 1.1

Secondary endpoints 6

1. Disease control (DC), Duration of response (DOR), Time to response (TTR), Progression free survival (PFS)
2. OR (CR and PR), DC, DOR, TTR, PFS
3. Overall survival (OS)
4. Incidence and severity of TEAEs, grade ≥ 3 TEAEs, SAEs, and EOIs
5. PK parameters of AMG 193 including, but not limited to Cmax, Tmax, and AUC
6. Changes in cancer-specific symptoms, treatment-related symptom and overall health status using subject-reported outcome instruments: o EORTC QLQ-C30 o QLQ LC13 o EQ-5D-5L o PRO-CTCAE o GP5 of FACT-G

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1730

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 14

Locations

12 EU/EEA countries · 64 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 2 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 207 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications