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
Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent
Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced/metastatic setting and for whom no approved or standard therapy is available.
Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.
Adequate Bone Marrow Function
Participants with disease suitable for local therapy with curative intent.
Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator
Prior treatment with any ADCs that have an active TOP1 inhibitor-based component
Sequential
ALX2004
DrugALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV Infusion
ALX2004
DrugALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
ALX2004
DrugALX2004 is a novel ADC targeting EGFR. Drug: ALX2004 IV infusion
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
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
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)
Phase 1a and 1b: Maximum Concentration (Cmax)
To evaluate the Cmax of ALX2004
Phase 1a and 1b: Time of Maximum Plasma Concentration (Tmax)
To evaluate the Tmax of ALX2004
Phase 1a and 1b: Clearance (CL)
To evaluate the clearance of ALX2004
Phase 1a and 1b: Area under the concentration time curve (AUC)
To evaluate the AUC of ALX2004
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