A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2029-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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 solid tumors.

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

Details

• Lead Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Gemcitabine; Pembrolizumab

Criteria

Inclusion Criteria:

1. Written informed consent is provided by patient or legally acceptable representative;

2. Age ≥ 18 years;

3. Patient populations:

a. 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 this study

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. I

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.