MedTrace Logo

A First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of TAX2 in Patients With Relapsed/Refractory Advanced/Metastatic Solid Tumours

NCT07688148 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-07

No results posted yet for this study

Summary

The purpose of this clinical trial is to investigate the treatment for adult patients suffering from advanced or metastatic solid tumours and has 2 parts to the study: the Phase 1 where ascending doses of the experimental study drug, TAX2, will be tested and the Phase 2a where all the participants will receive the study drug at the same dose considered as the recommended Phase 2 dose from Phase 1 part. The participation in the Phase 1 or in the Phase 2a part depends on when the participant is proposed to join the study.

The study purpose is to assess:

* How safe and tolerable TAX2 is. This assessment will be based on the adverse effects collected during the study.
* How well TAX2 enters the body, circulates in the body, and leaves the body (known as pharmacokinetics, PK) by measuring the level of the drug in the blood
* What the drug does with the body and the tumour (known as pharmacodynamics, PD)
* The effect TAX2 has on the tumours (anti-tumour activity)
* Also define the Dose Limiting Toxicity (DLT) and the recommended Phase 2 Dose (RP2D)

Conditions

  • Solid Tumor Cancers

Interventions

DRUG

TAX2

TAX2 will be administered once weekly (qw) on days D1, D8, D15 and D22 of repeated 28-day treatment cycles. Treatment continues until disease progression, unacceptable toxicity or patient withdrawal, whichever comes first.

Sponsors & Collaborators

  • Apmonia Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-02-28
Completion
2030-08-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688148 on ClinicalTrials.gov