QUILT-3.031: AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma

NCT03132155 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: QUILT-3.031
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 2 study that will assess the efficacy of AMG 337 in subjects with advanced or metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion.

Conditions

Clear Cell Sarcoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  1 year

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety And Tolerability)

  1 year

Study Arms (1)

AMG 337

EXPERIMENTAL

AMG 337 will be administered in patients with advanced or metastatic clear cell sarcoma

Drug: AMG 337

Interventions

AMG 337 DRUG

6-{(1R)-1-\[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)\[1,2,4\]triazolo\[4,3-a\]pyridin-3-yl\]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)

AMG 337

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• Able to attend required study visits and return for adequate follow-up, as required by this protocol.
• Able to self-administer AMG 337 as a whole capsule by mouth every day.
• Age ≥ 16 years.
• Histologically confirmed, unresectable, locally advanced or metastatic tumors that contain the EWSR1-ATF1 gene fusion, as determined by fluorescent in situ hybridization (FISH) or other diagnostic methods and confirmed by RNA sequencing (RNAseq).
• Have measurable disease evaluable in accordance with RECIST Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Must have a recent Formalin-fixed paraffin-embedded (FFPE) tumor biopsy specimen that was obtained following the conclusion of the most recent anticancer treatment. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
• Must be willing to undergo a biopsy during the treatment period, if considered safe by the investigator.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Hematologic function, as follows:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
• Platelet count ≥ 50 × 109/L.
• Hemoglobin \> 8 g/dL.
• Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 × upper limit of normal (ULN), except for subjects on anticoagulation therapy for venous thromboembolism.

You may not qualify if:

• Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
• Inability to attend required study visits and return for adequate follow-up, as required for this protocol.
• Known hypersensitivity to any component of the study medication(s).
• Women who are nursing, pregnant, or planning to become pregnant during the duration of the study.
• Current diagnosis or history of a second neoplasm, except the following:
• a. Adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
• History of bleeding diathesis.
• Uncontrolled hypertension (systolic \> 160 mmHg and/or diastolic \> 100 mmHg) or clinically significant cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months before study day 1; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
• Baseline ECG Fridericia's formula QTcF \> 470 ms.
• Active infection requiring intravenous (IV) antibiotics within 2 weeks before study day 1.
• Significant gastrointestinal disorder (eg, Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that in the opinion of the Investigator may influence drug absorption.
• Positive result of screening test for human immunodeficiency virus (HIV).
• Evidence of acute hepatitis B and C. Subjects with chronic hepatitis B or C are eligible if their condition is stable and, in the opinion of the investigator, would not pose a risk to subject safety.
• Toxicities from prior anti-tumor therapy not resolved to CTCAE Version 4.03 grade 0 or 1.
• Participation in this study or in an investigational study and/or procedure with any molecularly targeted agents reported to inhibit Mesenchymal epithelial transition factor (MET) within 14 days before study day 1.

Sponsors & Collaborators

• NantPharma, LLC: lead

Study Sites (2)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sarcoma, Clear Cell

Interventions

AMG 337

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Limitations and Caveats

The study was terminated early due to low enrollment. Only the safety data is provided.

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 27, 2017
• Study Start: August 29, 2018
• Primary Completion: August 13, 2021
• Study Completion: September 21, 2021
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)