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Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies

ConditionsUrachal CancerAdvanced Solid Tumor CancerAntibody-drug Conjugates
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheng Zhang

About this trial

This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg/kg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A1811

    Drug

    Trastuzumab Rezetecan (SHR-A1811) is administered at a dose of 4.8 mg/kg every 21 days (q3w), constituting one treatment cycle.

  • Trastuzumab Rezetecan

    Drug

    Patients who have failed standard therapy are treated with Trastuzumab Rezetecan

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Experimental group 1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The proportion of patients who achieved CR or PR according to RECIST V.1.1 criteria.

Objective Response Rate (ORR)

Time frame
Efficacy was assessed every 9 weeks for 1 year and every 12 weeks thereafter (assessed up to 3 years).

Secondary outcomes

1

Time from treatment start to progression by RECIST V.1.1.

Progression-free survival(PFS)

Time frame
From date of treatment until the date of first documented progression, assessed up to 100 months.
2

Time from treatment start to death of participants.

Overall Survival(OS)

Time frame
From date of treatment until the date of death from any cause, whichever came first, assessed up to 100 months.
3

Type, incidence, severity, onset and end time of adverse events (AE) evaluated according by the version 5.0 of NCI-CTCAE.

Evaluation of safety

Time frame
Began at 30 days (±7 days) after the last study treatment to 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheng Zhang

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov
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