Cancer combo trial halted early after enrolling only 5 patients
NCT ID NCT05949632
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug (INCB099280) combined with a standard cancer drug (axitinib) in adults with advanced solid tumors that had stopped responding to other treatments. The main goals were to check safety and see if the combination could shrink tumors. The trial was terminated early after enrolling only 5 people in the UK and EU.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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5 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Jun 2025
- 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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Female participants only
- 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: * Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered non-amenable to surgery or other curative treatments or procedures. * Must have disease progression on or after treatment with at least one prior systemic chemotherapy. * Eastern Cooperative Oncology Group performance status score of 0 or 1. * Life expectancy \> 12 weeks. * Willingness to avoid pregnancy. Exclusion Criteria: * Known additional malignancy that is progressing or requires active treatment. * Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease. * Toxicity from prior therapy that has not recovered to protocol-defined limits. * Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell). * Prior therapy with antiangiogenic small-molecule TKIs targeting the VEGF pathway * Participation in another interventional clinical study while receiving INCB099280. * Impaired cardiac function or clinically significant cardiac disease. * History or evidence of interstitial lung disease including noninfectious pneumonitis. * Presence of gastrointestinal conditions that may affect drug absorption. * Any autoimmune disease requiring systemic treatment in the past 5 years. * Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent. * Active infection requiring systemic therapy. * History of organ transplantation, including stem cell transplantation. * Receipt of systemic antibiotics within 28 days of first dose of study treatment. * Probiotic usage is prohibited during screening and throughout the study treatment period. * Received a live vaccine within 28 days of the planned start of study drug. * Laboratory values outside the Protocol-defined ranges. * Inadequate organ function. 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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Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
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Beatson West of Scotland Cancer Centrewester
Glasgow, G12 0YN, United Kingdom
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Guys Hospital
London, SE1 9RT, United Kingdom
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St Bartholomew'S Hospital
London, EC1A 7BE, United Kingdom
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The Royal Marsden
London, SW3 6JJ, United Kingdom
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The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, SM2 5PT, United Kingdom
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Other studies related to the condition(s) this trial covers.
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- Oral drug RVU120 put to the test against advanced solid tumors