Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03983954
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2019-05-27
Brief Title:
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors
Sponsor:
NeoTX Therapeutics Ltd
Organization:
NeoTX Therapeutics Ltd
Study Overview
Official Title:
Phase 1B Open-Label Dose Escalation and Cohort Expansions Trial of Naptumomab Estafenatox NAP ABR-217620 in Combination With Durvalumab MEDI4736 in Subjects With Selected Advanced or Metastatic Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a dose escalation MTD expansion Phase 1b and cohort expansions Phase 2 study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors
Detailed Description:
This Phase 1b open-label multicenter n3-5 prospective dose-finding and MTD cohort expansion study recruits patients with previously treated solid tumors known with high likelihood of 5T4 antigen expression on tumor cells
Patients in the dose-escalation part are treated with the combination of NAP and durvalumab using a fixed dose of durvalumab and the 33 design for NAP dose escalations The Maximum Tolerated Dose MTD of NAP for the combination treatment will be established based on Dose Limiting Toxicities DLTs occurring during the first cycle of the treatment
A second dose escalation part is performed at the second highest safe dose in the dose escalation phase pre-treated with obinutuzumab anti-CD20 for elimination of anti-drug antibodies ADAs to NAP In this part the safety of the NAP-durvalumab combination are assessed with obinutuzumab given prior to the initiation of that regimen
MTD expansion part in which approximately 10-15 patients are treated at the confirmed MTD of NAP Ten additional patients are enrolled at the previous dose level to assess whether a lower dose may achieves a better risk-benefit balance This cohort recruits patients with the same tumor types as in the escalation part as well as 5T4-positive colorectal cancer CRC and gastro-esophageal cancer GE Measurable disease is required This expansion cohort will help assess the biologic activity of the combination and to gain some preliminary insights on its potential antitumor activity
Additional group of approximately 10 patients Obi -7 group will be enrolled to test an abbreviated regimen of obinutuzumab pre-treatment A single infusion of 1000 mg obinutuzumab will be administered on day -7 prior to initiation of Cycle 1 of the combination of NAP and durvalumab NAP and durvalumab will be given in the same dose and regimen as in this MTD expansion cohort
The following solid tumors known to have 80 probability of 5T4 expression and thus may be included in both the dose escalation phase and the MTD expansion breast cancer epithelial ovarian cancer cervical and endometrial cancer pancreatic cancer renal and urothelial cancer head and neck mesothelioma melanoma hepatic carcinoma prostate cancer and Non-Small Cell Lung Cancer NSCLC Prior PD-1 or PD-L1 therapy is acceptable
Patients in the dose-escalation part are treated with the combination of NAP and durvalumab using a fixed dose of durvalumab and the 33 design for NAP dose escalations The Maximum Tolerated Dose MTD of NAP for the combination treatment will be established based on Dose Limiting Toxicities DLTs occurring during the first cycle of the treatment
A second dose escalation part is performed at the second highest safe dose in the dose escalation phase pre-treated with obinutuzumab anti-CD20 for elimination of anti-drug antibodies ADAs to NAP In this part the safety of the NAP-durvalumab combination are assessed with obinutuzumab given prior to the initiation of that regimen
MTD expansion part in which approximately 10-15 patients are treated at the confirmed MTD of NAP Ten additional patients are enrolled at the previous dose level to assess whether a lower dose may achieves a better risk-benefit balance This cohort recruits patients with the same tumor types as in the escalation part as well as 5T4-positive colorectal cancer CRC and gastro-esophageal cancer GE Measurable disease is required This expansion cohort will help assess the biologic activity of the combination and to gain some preliminary insights on its potential antitumor activity
Additional group of approximately 10 patients Obi -7 group will be enrolled to test an abbreviated regimen of obinutuzumab pre-treatment A single infusion of 1000 mg obinutuzumab will be administered on day -7 prior to initiation of Cycle 1 of the combination of NAP and durvalumab NAP and durvalumab will be given in the same dose and regimen as in this MTD expansion cohort
The following solid tumors known to have 80 probability of 5T4 expression and thus may be included in both the dose escalation phase and the MTD expansion breast cancer epithelial ovarian cancer cervical and endometrial cancer pancreatic cancer renal and urothelial cancer head and neck mesothelioma melanoma hepatic carcinoma prostate cancer and Non-Small Cell Lung Cancer NSCLC Prior PD-1 or PD-L1 therapy is acceptable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None