Experimental cancer combo shows early promise but trial halted
NCT ID NCT02936102
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a new drug called FAZ053, alone or with another drug (PDR001), in 154 adults with advanced solid tumors. The goal was to check safety and find the right dose by boosting the immune system to attack cancer. The study was terminated early, so full results are not available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FAZ053 (anti-PD-L1 antibody) and PDR001 (anti-PD-1 antibody)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors by boosting the immune system to fight cancer.
- What could go wrong
- This is a very early Phase 1 trial focused on safety, not effectiveness. The study was terminated early, so results may be limited. Immune-related side effects 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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
154 people
The number who actually took part.
- Started
-
Oct 2016
- Finished
-
Nov 2024
- Lead sponsor
-
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
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Written informed consent prior to any procedure. * Dose escalation cohorts of FAZ053 single agent and FAZ053 in combination with PDR001: Patients with advanced/metastatic solid tumors with measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor, who have progressed despite standard therapy, or for whom no standard therapy is available. * Dose expansion groups of FAZ053 single agent: Patients with advanced/metastatic solid tumors with at least one measurable lesion as determined by RECIST version 1.1 who may or may not have received prior treatment with an immune checkpoint inhibitor (for FAZ053 single agent no treatment with an anti-PD-L1 inhibitor is permitted), who have progressed despite standard therapy, or for whom no standard therapy is available and fit into one of the following groups: * FAZ053 single agent: TNBC/ Chordoma/ ASPS * Performance Status (PS) ≤ 2: * Patient must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening/ baseline and during therapy on this study. Exclusion Criteria: * Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy (e.g. radiotherapy or surgery) or increasing doses of corticosteroids within the prior 2 weeks. Patients with treated brain metastases should be neurologically stable (for 4 weeks post-treatment and prior to study enrollment) and off of steroids for at least 2 weeks before administration of any study treatment. * History of severe hypersensitivity to study treatment excipients and additives or other monoclonal antibodies (mAbs) and/or their excipients. * Active, known or suspected autoimmune disease. Patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded. * Treatment with cytotoxic or targeted antineoplastics within 3 weeks of initiation of study treatment. For cytotoxic agents that have major delayed toxicity a washout period of one cycle is indicated (examples are nitrosoureas and mitomycin C which typically require a 6 week washout). Prior antibodies or immunotherapies require a 6 week washout. * Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10mg/day prednisone or equivalent). Topical, inhaled, nasal and ophthalmic steroids are allowed. * Active infection requiring systemic antibiotic therapy. Other protocol-defined inclusion/exclusion criteria may apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10065, United States
-
Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
-
Novartis Investigative Site
Toulouse, 31059, France
-
Novartis Investigative Site
Tel Aviv, 6423906, Israel
-
Novartis Investigative Site
Milan, MI, 20133, Italy
-
Novartis Investigative Site
Modena, MO, 41124, Italy
-
Novartis Investigative Site
Koto Ku, Tokyo, 135 8550, Japan
-
Novartis Investigative Site
Singapore, 119074, Singapore
-
Novartis Investigative Site
Seville, Andalusia, 41013, Spain
-
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
-
Novartis Investigative Site
Taipei, 10002, Taiwan
-
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to why some cancer treatments work better
- 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?