and therefore all participants will be minors at the time of consent., Participants with relapsed HRNB and participants with HRNB refractory to treatment The clinical trial will recruit participants aged ≥18 months to <18 years
Conditions
Brief summary
Primary efficacy endpoint defined in Sub Protocol, Sub Protocol A: ORR defined as the proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve a CR or PR according to the INRC Sub Protocol B: mCRR defined as the proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve an overall mCR response
Detailed description
Multiple secondary endpoints as described in Protocol Section M.2, A2 and B2.
Interventions
Sponsors
Renaissance Pharma Limited
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint defined in Sub Protocol, Sub Protocol A: ORR defined as the proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve a CR or PR according to the INRC Sub Protocol B: mCRR defined as the proportion of participants treated with hu14.18K322A in combination with chemotherapy who achieve an overall mCR response | — |
Secondary
| Measure | Time frame |
|---|---|
| Multiple secondary endpoints as described in Protocol Section M.2, A2 and B2. | — |
Outcome results
None listed