New drug combo aims to shrink Hard-to-Treat cancers
NCT ID NCT05318573
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2a trial tests a new form of the chemotherapy drug gemcitabine (FF-10832) given alone or with the immunotherapy pembrolizumab (Keytruda) in 120 adults with advanced bladder or non-small cell lung cancer. The study first checks safety and finds the best dose, then looks at whether the treatment can keep tumors from growing. All participants have already tried standard treatments without success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FF-10832 (gemcitabine liposome injection) and pembrolizumab (Keytruda)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced bladder or lung cancer that has stopped responding to standard therapies.
- What could go wrong
- This is an early phase 2a study with a small number of participants. The main goal is safety and dosing, not proof of effectiveness. Side effects from chemotherapy and immunotherapy can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, 07960, United States
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Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
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Cancer and Blood Speciality Clinic
Long Beach, California, 90806, United States
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Comprehensive Cancer Centers of Nevada - Southern Hills
Las Vegas, Nevada, 89148, United States
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Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202, United States
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Hospital of the Univ of Pennsylvania Perlman Center
Philadelphia, Pennsylvania, 19104, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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NYU Langone Health
New York, New York, 10016, United States
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Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, 68130, United States
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Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
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Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
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Sharp Memorial Hospital (Oncology Clinical Research)
San Diego, California, 92123, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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TriHealth Cancer Institute; Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205, United States
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University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
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University of Louisville Brown Cancer Center
Louisville, Kentucky, 40202, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
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University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792, United States
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Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
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Washington University School of Medicine, Center for Adv Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors