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Trials
ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors

trialsTrialRecruiting

ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors

A phase 1/2 trial of AVZO-021 and Fulvestrant in advanced solid tumours, run by Avenzo Therapeutics, Inc., now recruiting.

Also called: ORION-1

Overview Connected5

Overview

ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT06998407 by Avenzo Therapeutics, Inc., with 380 participants planned, started 2025-08-20 and due to reach its primary completion in 2028-08. Interventions recorded: AVZO-021, Fulvestrant, Letrozole and AVZO-023.

Setting

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors

Phase

Phase 1/2

Sponsor

Avenzo Therapeutics, Inc.

Registry

Started

2025-08-20

Enrolled

380 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

drugs

Phase 2small molecule (structure undisclosed or not yet in PubChem)

Phase 2Small-molecule inhibitor

ApprovedInjectable SERD

Fulvestrant · Faslodex

companies

Avenzo Therapeutics

Evidence strength26/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
380 enrolled+13
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-18 · Jude Gomila · Trial acronyms for registry records · diff · file

Sources & links

ClinicalTrials.gov NCT06998407

Data

JSON ·

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How review works

Cancers

Metastatic cancer (cancer that has spread)

Products

AVZO-021
Fulvestrant
AVZO-023

Companies

Avenzo Therapeutics

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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