New drug combo shows early promise in Hard-to-Treat cancers
NCT ID NCT05162755
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a new drug called S095029, alone and combined with another drug (Sym021), in 41 people with advanced solid tumors that had stopped responding to standard treatments. The main goal was to check safety and side effects. The study was stopped early for business reasons, not due to safety concerns, so we don't yet know if the combination works well.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- S095029 (a drug that targets NKG2A) and Sym021 (a drug that targets PD-1)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 41 participants, so it is primarily testing safety, not effectiveness. The expansion part was stopped early for business reasons, so results are limited.
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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41 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
Dose escalation part: Inclusion Criteria: * Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies * Patients with a malignancy not amenable to surgical intervention * Patients with measurable disease and progression radiologically assessed * Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment. * Patients with available archived tumor biopsy specimens or agree to mandatory biopsy * Estimated life expectancy ≥ 12 weeks * Adequate haematological function * Adequate renal function * Adequate hepatic function Exclusion Criteria: * Pregnant and lactating women * Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery * Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration * Active Hepatitis B Virus infection * Carriers of HIV antibodies * Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration * History of organ transplantation * History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion * History of cirrhosis * History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition * Treatment with systemic immunosuppressive therapy * Active autoimmune disease * Administration of a live vaccine within 28 days prior to inclusion
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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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Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
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Princess Margaret Cancer Centre
Toronto, Canada
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START Midwest
Grand Rapids, Michigan, 49546, United States
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The START Center for Cancer Care
San Antonio, Texas, 78229, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors