WithdrawnPhase 1

A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors

Stopped: In accordance with the strategic decision of the company's senior management team, no participants have been consented or enrolled.

Australia0Started 2025-03-01

Plain-language summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-4602 in subjects with HER2-expressing or HER2-mutated locally advanced or metastatic solid tumors.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
✓. ECOG PS score 0 or 1
✓. Life expectancy ≥ 12 weeks
✓. Adequate bone marrow and other vital organ functions
✓. Adequate liver function tests
✓. HER 2 exprission advanced solid tumor

Exclusion criteria

✕. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
✕. ECOG PS score 0 or 1
✕. Life expectancy ≥ 12 weeks
✕. Adequate bone marrow and other vital organ functions
✕. Adequate liver function tests
✕. HER 2 exprission advanced solid tumor
✕. Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.
✕. Have received surgery (eg. major surgerical treatment for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose of investigational drug (palliative radiotherapy within 2 weeks prior to the first dose).

What they're measuring

the phase II dose (RP2D) of SHR-4602

Timeframe: From the time when the subjects sign the informed consent form to 45(±3) days after the last dose of SHR-4602, or the start of new anti-tumor treatment (whichever comes first).assessed for a maximum duration of up to 1 year

Trial details

NCT IDNCT06560138

SponsorAtridia Pty Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-14

View on ClinicalTrials.gov More HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors trials