A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

Phase 1a and 1b: Maximum Concentration (Cmax)

To evaluate the Cmax of ALX2004

Time frame: Up to 2 years

Phase 1a and 1b: Time of Maximum Plasma Concentration (Tmax)

To evaluate the Tmax of ALX2004

Time frame: Up to 2 years

Phase 1a and 1b: Clearance (CL)

To evaluate the clearance of ALX2004

Time frame: Up to 2 years

Phase 1a and 1b: Area under the concentration time curve (AUC)

To evaluate the AUC of ALX2004

Time frame: Up to 2 years

Phase 1a and 1b: Terminal elimination half-life (t1/2)

To evaluate the t1/2 of ALX2004

Time frame: Up to 2 years

Phase 1a: Overall Response Rate (ORR) per investigator assessment using RECIST v1.1

Phase 1a: 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 dose

Phase 1a and 1b: Evaluate the immunogenicity of ALX2004

Measured by the presence of human plasma ADA (Anti-ALX2004 antibodies)

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

AEs as characterized by type, frequency, severity (as graded by the NCI CTCAE v.5.0) timing, seriousness, and relationship to study drug. Laboratory abnormalities as characterized by type, frequency, severity and timing

Time frame: Up to 2 years from first patient dosed in dose expansion phase

Phase 1a and 1b: Progression Free Survival (PFS)

PFS is defined as the time (in months) from the date of the first dose of ALX2004 to the date of the first instance of progressive disease or death

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)

OS is defined as the time (in months) from the date of the first dose of ALX2004 to the date of death

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)

BOR is defined as the best response reached during the course of the trial from the response categories of CR, PR, SD, PD, and No Response using RECIST v1.1

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)

DCR is defined as the proportion of participants whose BOR is PR, CR, or SD

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)

DoR is defined as the time (in months) from the first instance of a BOR, of CR/PR until the date of the first instance of progressive disease

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