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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04064190
Other study ID # MP-VAC-202
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date October 15, 2021
Est. completion date December 30, 2024

Study information

Verified date September 2021
Source MedPacto, Inc.
Contact Sunjin Hwang, MD
Phone +82 2 6938 0206
Email sunjin.hwang@medpacto.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1/PD-L1 based regimens


Description:

This is a Phase 2, open-label, non-randomized, two-cohort multi center study with a safety run-in of 6 patients in Cohort 1. It is anticipated that a total of 48 patients will be enrolled. Durvalumab will be administered with the standard regimen of 1500 mg intravenously (IV) every four weeks. Vactosertib will be administered at a dose of 300 mg PO BID for 5 days per week All treatment will be administered up to two years and the trial is anticipated to be completed over a period of 36 months.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date December 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment 2. Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra. 3. Prior anti-PD-(L)1 treatment. 4. Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI. 5. Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy. 6. Adequate organ and marrow function as defined 7. Must have a life expectancy of at least 12 weeks. 8. Body weight > 30 kg Exclusion Criteria: 1. History of allogeneic organ transplantation. 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure . 4. History of another primary malignancy 5. History of leptomeningeal carcinomatosis. 6. History of active primary immunodeficiency. 7. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus . 8. Any unresolved toxicity NCI CTCAE Grade = 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

Study Design


Intervention

Drug:
Vactosertib(TEW-7197)/ Durvalumab
Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks

Locations

Country Name City State
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States University of California San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
MedPacto, Inc. AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate ORR by RECIST version 1.1 12months
Secondary Time to Tumor Response TTR by RECIST version 1.1 and iRECIST Overall study period up to 3years
Secondary Best Response Best response (percent of tumor shrinkage) by RECIST version 1.1 and iRECIST Overall study period up to 3years
Secondary Duration of Response DoR by RECIST version 1.1 and iRECIST Overall study period up to 3years
Secondary Progression Free Survival PFS by RECIST version 1.1 and iRECIST 6-month/ 12-month
Secondary Overall survival OS by RECIST version 1.1 and iRECIST 12month
Secondary Tumor-specific immune responses tumor-specific immune responses within on-therapy biopsies measured by increased T cell infiltration and increased IFN-? signature. and the correlation with outcome as measured by ORR, TTR, DoR, PFS and OS Overall study period up to 3years
Secondary Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] To assess safety and tolerability of vactosertib administered concurrent with Durvalumab in patients with urothelial carcinoma failing checkpoint inhibition Overall study period up to 3years
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