A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors
Summary
A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors
Detailed description
This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion. The study will enroll previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). Up to 170 patients are expected to be enrolled in the study.
Arms & interventions
- DrugALX2004
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
- DrugALX2004
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
- DrugALX2004
ALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
Outcome measures
Primary
Phase 1a: Incidence of dose limiting toxicities (DLTs)
Phase 1a: Number and proportion of participants enrolled in the dose escalation phase who experience dose-limiting toxicities (DLTs), received at least one dose of ALX2004 and completed the DLT evaluation
Time frame: Up to 28 days
Phase 1a: Incidence of treatment emergent adverse events
Phase 1a: Adverse Events as characterized by type, frequency, severity (NCI CTCAE v5.0), timing, seriousness, and relationship to the study drug in order to establish the RDE. Laboratory abnormalities as characterized by type, frequency, severity and timing
Time frame: Up to 2 years from first dose
Phase 1b: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1
Phase 1b: ORR is defined as proportion of participants whose BOR is complete response (CR) or partial response (PR)
Time frame: Up to 2 years from first patient dosed in dose expansion phase
Secondary
Phase 1a and 1b: Maximum Concentration (Cmax)
Time frame: Up to 2 years
Phase 1a and 1b: Time of Maximum Plasma Concentration (Tmax)
Time frame: Up to 2 years
Phase 1a and 1b: Clearance (CL)
Time frame: Up to 2 years
Phase 1a and 1b: Area under the concentration time curve (AUC)
Time frame: Up to 2 years
Phase 1a and 1b: Terminal elimination half-life (t1/2)
Time frame: Up to 2 years
Phase 1a: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1
Time frame: Up to 2 years from first dose
Phase 1a and 1b: Evaluate the immunogenicity of ALX2004
Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase
Phase 1b: Incidence of treatment emergent adverse events
Time frame: Up to 2 years from first patient dosed in dose expansion phase
Phase 1a and 1b: Progression Free Survival (PFS)
Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase
Phase 1a and 1b: Overall Survival (OS)
Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase
Phase 1a and 1b: Best Overall Response (BOR)
Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase
Phase 1a and 1b: DCR (Disease Control Rate)
Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase
Phase 1a and 1b: Duration of Response (DoR)
Time frame: Phase 1a: Up to 2 years from first dose. Phase 1b: Up to 2 years from first patient dosed in dose expansion phase
Eligibility criteria
Study locations (8)
ALX Center 7
Tampa, Florida, 33612
ALX Center 8
Farmington Hills, Michigan, 48334
ALX Center 3
Grand Rapids, Michigan, 49546
ALX Center 6
Portland, Oregon, 97213
ALX Center 5
Houston, Texas, 77030
ALX Center 4
West Valley City, Utah, 84119
ALX Center 2
Fairfax, Virginia, 22031
ALX Center 1
Spokane, Washington, 99208