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A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516551-41-00
Acronym
JZP598-206
Enrollment
50
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with HER2-expressing solid tumors

Brief summary

cORR per ICR as assessed by RECIST version 1.1

Detailed description

1. DOR per ICR as assessed by RECIST version 1.1 • Investigator-assessed cORR and DOR per RECIST version 1.1 • ICR- and investigator-assessed (per RECIST version 1.1): − TTR − DCR − PFS • OS, 2. Frequency of TEAEs and SAEs as graded by • NCI CTCAE version 5.0 or higher • Frequency of dose reductions • Frequency of discontinuations of treatment due to TEAEs, 3. Serum concentrations of zanidatamab, 4. Frequency, duration, and time of onset of anti-zanidatamab antibodies and neutralizing antibodies, if applicable, 5. The frequency and severity of symptomatic AEs prior to first dose of study intervention and during the on-treatment period, based on the PRO-CTCAE and EORTC Item Library • The percent of all treated participants reporting each level of side-effect bother while on treatment, based on the FACIT-GP5 •The level of side-effect bother reported over time per participant, summarized as the percent of time on treatment with high side-effect bother, based on the FACIT-GP5

Interventions

DRUGJZP598

Sponsors

Jazz Pharmaceuticals Ireland Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
cORR per ICR as assessed by RECIST version 1.1

Secondary

MeasureTime frame
1. DOR per ICR as assessed by RECIST version 1.1 • Investigator-assessed cORR and DOR per RECIST version 1.1 • ICR- and investigator-assessed (per RECIST version 1.1): − TTR − DCR − PFS • OS, 2. Frequency of TEAEs and SAEs as graded by • NCI CTCAE version 5.0 or higher • Frequency of dose reductions • Frequency of discontinuations of treatment due to TEAEs, 3. Serum concentrations of zanidatamab, 4. Frequency, duration, and time of onset of anti-zanidatamab antibodies and neutralizing antibodies, if applicable, 5. The frequency and severity of symptomatic AEs prior to first dose of study intervention and during the on-treatment period, based on the PRO-CTCAE and EORTC Item Library • The percent of all treated participants reporting each level of side-effect bother while on treatment, based on the FACIT-GP5 •The level of side-effect bother reported over time per participant, summarized as the percent of time on treatment with high side-effect bother, based on the FACIT-GP5

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026