RecruitingPhase 1

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

United States170 participantsStarted 2025-08-18

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Phase 1a: Incidence of dose limiting toxicities (DLTs)

Timeframe: Up to 28 days

Phase 1a: Incidence of treatment emergent adverse events

Timeframe: Up to 2 years from first dose

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

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

Trial details

NCT IDNCT07085091

SponsorALX Oncology Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Athanasios Tsiatis, MD

650-466-7125 info@alxoncology.com

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