Brief Title: FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Determine the incidence of Treament Emergent Adverse Events (TEAE)

Primary Outcome 1 - Timeframe: 7 years

Primary Outcome 2 - Measure: Duration of Stable Disease in Monotherapy

Primary Outcome 2 - Timeframe: 7 years

Primary Outcome 3 - Measure: Duration of Stable Disease in Combination Therapy

Primary Outcome 3 - Timeframe: 7 years

CONDITION

• Advanced Urothelial Carcinoma
• Advanced Non Small Cell Lung Cancer

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

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Role: N/A

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Overall Contact

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LOCATION