A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
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|ClinicalTrials.gov Identifier: NCT04928677|
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : June 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Primary Extra-cranial Solid Tumor Recurrent or Refractory Glypican 3 (GPC3)||Drug: Codrituzumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase I, open-label, dose-escalation, multi-center study in pediatric patients 12 months through 21 years of age with GPC3 expressing extra-cranial solid tumors.|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Phase I Study of Codrituzumab in Pediatric Patients With Relapsed or Refractory Glypican 3 (GPC3) Expressing Extra-cranial Solid Tumors|
|Actual Study Start Date :||June 9, 2021|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
For Phase A of the study, we will use the 3+3 study design, with 2 planned dose levels, starting at 50% of the adult RP2D to confirm the pediatric RP2D/MTD. 6-9,43 Phase B will include an expansion cohort for patients with hepatoblastoma.
For Phase A (Dose Escalation), the starting dose (dose level 1) will be 10 mg/kg with 1 planned dose escalation to 20 mg/kg (dose level 2) if dose level 1 is determined to be safe and tolerable. Once a RP2D/MTD is identified in Phase A, then Phase B (hepatoblastoma expansion cohort) will open and allow for enrollment of up to 10 additional patients.For both phases, patients will receive codrituzumab IV once per week for a period of 21 days per cycle. Patients will be eligible for up to 25 cycles.
- estimate the MTD [ Time Frame: 1 year ]The Phase A dose escalation scheme will follow a 3+3 design.
- response rate [ Time Frame: at 6 weeks ]partial + complete response according to RECIST v1.1)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04928677
|Contact: Michael Ortiz, MDemail@example.com|
|Contact: Julia Glade Bender, MD||1-833-675-5437|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Michael Ortiz, MD 833-675-5437|
|Principal Investigator:||Michael Ortiz, MD||Memorial Sloan Kettering Cancer Center|