ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors (AMPLIFY-201)

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

For NED (no evidence of disease) patients, who had KRAS/NRAS mutated, G12D or G12R, solid tumor, including colorectal cancer.

Location Location Status
United States
City of Hope
Duarte, California 91010
Active, not recruiting
University of California Los Angeles
Los Angeles, California 90095
Active, not recruiting
University of Colorado
Aurora, Colorado 80045
Active, not recruiting
University of Iowa
Iowa City, Iowa 52242
Active, not recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
Active, not recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
Active, not recruiting
Northwell Health
Lake Success, New York 11042
Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
Active, not recruiting
Tennessee Oncology - Centennial Clinic
Nashville, Tennessee 37203
Active, not recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

* KRAS/NRAS mutated (G12D or G12R) solid tumor
* Positive for circulating tumor DNA (ctDNA) and/or elevated serum tumor biomarker despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
* Screening CT is negative for recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Exclusion Criteria:

* Presence of tumor mutations where specific therapy is approved, and the patient is able to receive the approved therapy
* Known brain metastases
* Use of immunosuppressive drugs

NCT ID

NCT04853017

Date Trial Added

2021-04-21

Updated Date

2025-01-17