Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedPacto, Inc.
• Collaborator: AstraZeneca
• Treatments: Antibodies, Monoclonal; Durvalumab

Criteria

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