A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer

Launched by FUJIFILM PHARMACEUTICALS U.S.A., INC. · Apr 7, 2022

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ClinConnect Summary

This clinical trial is studying a new treatment combination for patients with advanced urothelial cancer or non-small cell lung cancer (NSCLC). The treatment involves two drugs: FF-10832, which is given as an injection, and pembrolizumab, which is also given through an injection. Both medications are administered on the first day of a 21-day treatment cycle. The goal of the study is to find the best and safest dose of FF-10832 when used with pembrolizumab to help patients whose cancer has not responded to prior treatments.

To participate in this trial, you need to be at least 18 years old and have advanced urothelial cancer or NSCLC that has not improved after previous therapies. You should also be in reasonably good health, meaning you can carry out everyday activities with little difficulty. Participants will receive careful monitoring throughout the study, and they will have regular check-ups to assess how the treatment is affecting their health and cancer. This trial is currently recruiting participants, and anyone interested should discuss their eligibility with their healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent is provided by patient or legally acceptable representative;
• • 2. Age ≥ 18 years;
• 3. Patient populations:
• • 1. In the Safety Run-in, patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with standard therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment or refuse standard treatment will be enrolled in therapy
• • 2. In Expansion Phase, patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1
• • 4. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
• • 5. Eastern Cooperative Oncology Group performance status of 0 to 1
• • 6. Life expectancy of ≥ 3 months
• Exclusion Criteria:
• • 1. Positive urine pregnancy test within 72 hours prior to treatment
• • 2. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment;
• • 3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), AND was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event;
• • 4. Has received prior radiotherapy within 2 weeks of start of study treatment.
• 5. For patients with NSCLC:
• • 1. Patients who have received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of trial treatment are excluded;
• • 2. Patients with mutations (e.g., EGFR mutations or ALK gene rearrangements) will be excluded unless they have been previously treated with all specific targeted therapies.
• • 6. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
• • 7. Has had an allogeneic tissue /solid organ transplant.