UPCC 10522 A Phase 2a Study with Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors

Investigating the Safety and Efficacy of an Investigational Medication in Advanced Solid Tumors

Enrolling By Invitation
18 years or above
All
Phase 2
120 participants needed
1 Location

Brief description of study

To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer

Detailed description of study

This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg).

After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer [UC] and non-small cell lung cancer [NSCLC]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC.

The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Advanced Urothelial Carcinoma, Advanced Non Small Cell Lung Cancer
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the safety, tolerability, and preliminary effectiveness of an investigational medication, either alone or in combination with another treatment, for patients with advanced solid tumors. The study includes patients with specific types of cancer, such as urothelial cancer and non-small cell lung cancer, who have not responded to previous therapies targeting PD-1 or PD-L1 proteins, which are involved in the immune system's response to cancer.

Participants in the study will receive the investigational medication either as a single treatment or combined with another medication. The study begins with a safety phase to determine the appropriate dose of the investigational medication when used alongside the other treatment. After this phase, more patients will be enrolled to further assess the treatment's safety and its effects on tumor activity. Patients will be randomly assigned to receive either the investigational medication alone or in combination with the other treatment.

  • Who can participate: Adults aged 18 and older with advanced or metastatic solid tumors, who have progressed after standard treatments or cannot tolerate them, are eligible. Participants must have measurable disease and a life expectancy of at least 3 months.
  • Study details: Participants will receive the investigational medication either alone or in combination with another treatment. The study will evaluate the safety and effectiveness of these treatments in patients with advanced cancers.
Updated on 28 Jul 2026. Study ID: 22-0645
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