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

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NCT07085091 · readout ≤ 315 d

Sponsored by ALX Oncology Inc. (industry) · ALXO — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

170estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-08-18

actual

When the study began enrolling

Primary completion

Jun 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Dec 2027

estimated

The whole study's end, after follow-up

First posted

2025-07-25

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-12

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)
HNSCC
CRC (Colorectal Cancer)
ESCC
Colo-rectal Cancer
Head and Neck Cancer
Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Drug: ALX2004
Drug: ALX2004
Drug: ALX2004

Primary outcomes

what the primary-completion date above is the date OF

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

measured Up to 28 days

Phase 1a: Incidence of treatment emergent adverse events

measured Up to 2 years from first dose

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

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

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