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New drug combo shows promise in Hard-to-Treat cancers
NCT ID NCT04303858
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new drug called eciskafusp alfa, alone or with another immunotherapy (atezolizumab), in 189 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and find the right dose. The study was terminated early, but results help guide future research.
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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189 people
The number who actually took part.
- Started
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May 2020
- Finished
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Oct 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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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: * Locally advanced/unresectable or metastatic disease * No standard of care (SoC) (approved) treatments are available for the participant, or the participant cannot tolerate such treatments * Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Eastern Cooperative Oncology Group Performance Status 0 to 1 * Life expectancy of \>=12 weeks * Consent to provide an archival tumor tissue sample * Adequate cardiovascular, hematological, coagulative, hepatic and renal function Exclusion Criteria: * Rapid disease progression or suspected hyperprogression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention * Untreated central nervous system (CNS) metastases * Treated asymptomatic CNS metastases * Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>= 2 weeks before Cycle1 Day 1 (C1D1) * Active or history of carcinomatous meningitis/leptomeningeal disease * Uncontrolled tumor-related pain or symptomatic hypercalcemia * Concurrent second malignancy * Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results * Episode of significant cardiovascular/cerebrovascular acute disease within 28 days before study treatment administration * Active or uncontrolled infections * Known HIV infection * Hepatitis B virus (HBV) or hepatitis C virus infection * Adverse events related to any prior radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure must have resolved to Grade \<=1, except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or hypopituitarism on a stable dosage of hormone replacement therapy * Participants with bilateral pleural effusion * Major surgery or significant traumatic injury \< 28 days before study treatment administration or anticipation of the need for major surgery during study treatment * Known allergy or hypersensitivity to any component of the formulations of the IMPs to be administered, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanized antibodies * History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins * Previous treatment with Interleukin-2 (IL-2)/Interleukin-5 (IL-15)-like cytokines. IL-2/IL-15 use as an adjunct treatment component for adoptive cell therapy is permitted. In Part 3, patients who have received adoptive cell therapy such as tumor-infiltrating lymphocytes (TIL) are excluded.
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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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Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
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Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
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Erasmus MC
Rotterdam, 3015 GD, Netherlands
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Herlev Hospital
Herlev, 2730, Denmark
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Hospital Clinic Barcelona
Barcelona, 08036, Spain
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Hospital del Mar
Barcelona, 08003, Spain
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NKI/AvL
Amsterdam, 1066 CX, Netherlands
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Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, 02-781, Poland
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Rigshospitalet
København Ø, 2100, Denmark
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UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
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Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
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Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
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- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors