New drug combo takes on advanced cancers in early trial
NCT ID NCT05544929
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a new drug called KFA115, either by itself or combined with the immunotherapy Keytruda (pembrolizumab), in 126 people with advanced cancers like lung, skin, kidney, and others. The main goal is to check safety and find the best dose. It is not yet known if the drug works against the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KFA115 (an immunomodulatory drug) and pembrolizumab (Keytruda, an immunotherapy)
- What this could lead to
- If successful, this could point toward a new treatment option for several advanced cancers that have stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial focused on safety and dosing, not on effectiveness. It is small (126 people) and includes many cancer types, so results may not apply broadly. Side effects are unknown.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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126 people
The number who actually took part.
- Started
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Oct 2022
- Expected to finish
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Sep 2027
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 to 100 years
- 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: * Non-small cell lung cancer with historic PD-L1 ≥ 1%, as determined locally using a clinically accepted assay. Patients must have experienced benefit from previous anti-PD(L)1-containing therapy for at least 4 months based on investigator-assessed disease stability or response prior to developing documented disease progression. Patients must have also received prior platinum-based chemotherapy, either in combination or in sequence with anti-PD-(L)1, unless patient was ineligible to receive such treatment. * Renal cell carcinoma, clear cell histology, previously treated with anti-PD(L)1-containing therapy and a VEGF targeted therapy as monotherapy or in combination. Patients should have documented disease progression following anti-PD(L)1-containing therapy. * Cutaneous melanoma, previously treated with anti-PD(L)1-containing therapy. Patients should have documented disease progression following anti-PD(L)1-containing therapy. Patients with BRAF V600-mutant melanoma must have also received prior therapy with a BRAF V600 inhibitor, with or without a MEK inhibitor. * Ovarian cancer, high-grade serous histology, naïve to anti-PD(L)1 therapy, must have received one prior systemic therapy in platinum-resistant setting. * Nasopharyngeal carcinoma, non-keratinizing locally advanced recurrent or metastatic. Depending on the study arm, patients may be naïve to anti-PD(L)1 therapy, or previously treated with platinum-based chemotherapy with or without anti-PD-(L)1. * Locally advanced unresectable or metastatic triple negative breast cancer, ovarian cancer (high-grade serous histology), anal cancer (squamous), MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC. * Locally advanced unresectable or metastatic anal cancer (squamous), thymic carcinoma, MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC, all naïve to anti-PD(L)1 therapy and for whom anti PD(L)1 therapy is not available. * Triple negative breast cancer with historic PD-L1 CPS ≥ 1%, must have received at least one line of chemotherapy. In addition, these patients must have previously received sacituzumab govitecan, and in the case of a BRCA mutation a PARP inhibitor, if these treatments are locally approved and accessible to the patient. Exclusion Criteria: * Impaired cardiac function or clinically significant cardiac disease. * Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study. * History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients. * Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur may be considered. 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. * Any evidence of interstitial lung disease (ILD) or pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids. * Patients who discontinued prior anti-PD-(L)1 therapy due to an anti-PD-(L)1-related toxicity (applicable to the KFA115 in combination with pembrolizumab treatment arms). * Patients with symptomatic peripheral neuropathy limiting instrumental activities of daily living. Other protocol-defined inclusion/exclusion criteria may apply
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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
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Massachusetts General Hospital .
Boston, Massachusetts, 02114, United States
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NYU School of Medicine
New York, New York, 10015, United States
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Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
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Novartis Investigative Site
Guangzhou, Guangdong, 510080, China
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Novartis Investigative Site
Beijing, 100036, China
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Novartis Investigative Site
Lyon, 69373, France
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Novartis Investigative Site
Dresden, Saxony, 01307, Germany
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Novartis Investigative Site
Essen, 45147, Germany
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Novartis Investigative Site
Hong Kong, 999077, Hong Kong
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Novartis Investigative Site
Milan, MI, 20133, Italy
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Novartis Investigative Site
Modena, MO, 41124, Italy
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Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045, Japan
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Novartis Investigative Site
Singapore, 119074, Singapore
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Novartis Investigative Site
Seoul, 03080, South Korea
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Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
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Novartis Investigative Site
Taipei, 10002, Taiwan
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SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
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