Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors (NCT04487236) | Clinical Trial Compass
CompletedPhase 1
Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors
China61 participantsStarted 2020-10-15
Plain-language summary
This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors.
The study will consist of three phases: phase 1a (dose escalation with ZN-A-1041 monotherapy), phase 1b (dose escalation with ZN-A-1041 in combination with Capecitabine and Trastuzumab) and phase 1c (dose expansion with ZN-A-1041 in combination with Capecitabine and Trastuzumab).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients should be relapsed or refractory to existing therapy(ies) or have been intolerant of such therapies
✓. Have at least one extracranial measurable lesion by RECIST v1. 1 ii. For patients with brain metastasis, the following criteria should be met:
✓. For patients who have received previous local treatment (surgery, whole brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS)) for brain metastases, stable or progression of intracranial lesions is required. Interval from prior local therapy could be 3 weeks from WBRT and 2 weeks from SRS.
✓. Symptomatic or not, patient has not received previous local treatment (surgery or radiotherapy) for brain metastases as long as no local therapy is needed during the trial period.
✓. For patients who have received previous local treatment (surgery, whole brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS)) for brain metastases, stable or progression of intracranial lesions is required. Interval from prior local therapy could be 3 weeks from WBRT, 2 weeks from SRS and 4 weeks from surgery
✓. Symptomatic or not, patient has not received previous local treatment (surgery or radiotherapy) for brain metastases as long as no local therapy is needed during the trial period
✓. Have at least one measurable lesion and is suitable for accurate repeated assessable by RECIST 1.1, and the patient has an imaging-diagnosable intracranial lesion;
✓. Patients should not include suspected or confirmed meningeal metastases;
Exclusion criteria
✕
What they're measuring
1
The safety/tolerability of ZN-A-1041 as a monotherapy on Phase 1a
Timeframe: 23days
2
The safety/tolerability of ZN-A-1041 in combination with Capecitabine and Trastuzumab in Phase 1b
Timeframe: 21days
3
The safety of ZN-A-1041 in combination with Capecitabine and Trastuzumab in Phase 1c
Timeframe: through study completion, an average of 3 year
✕. Any intracranial lesion thought to require immediate local therapy
✕. Require antiepileptic treatment (except for these patients with stable seizures require continuous Levetiracetam therapy).
✕. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \> 2 mg of dexamethasone (or equivalent)