New drug combo takes on tough cancers in early trial
NCT ID NCT04896697
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This early-phase trial tested a new drug called vilastobart, alone or with another drug (atezolizumab), in 125 people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and find the right dose. Researchers also looked for signs that the tumors shrank.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vilastobart (XTX101) and atezolizumab
- What this could lead to
- If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is a very early first-in-human trial, so safety and effectiveness are not yet proven. The small size and early phase mean results may not lead to a widely available treatment.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
125 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
-
May 2026
- 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 years and older
- 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: Disease Criteria - * Part 1A and 1C: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available; * Part 1B: * Any histologically or cytologically confirmed solid tumor malignancy for which anti-PD-1 or anti-PD-L1 treatment is approved and has progressed on or after prior anti-PD-1 or anti-PD-L1 therapy. * Patients with metastatic castrate-resistant prostate cancer if they have progressed on at least 2 lines of systemic therapy * Patients with extensive stage small cell lung cancer (SCLC) after at least 1 line of prior therapy * Patients with microsatellite stable colorectal cancer after at least 2 lines of prior therapy * Phase 2: Patients with histologically confirmed metastatic MSS CRC are eligible to enroll in Phase 2 as follows: * Patients must have had at least 1 prior chemotherapy regimen for metastatic CRC including all of the following agents: a fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab or biosimilars, an anti epidermal growth factor receptor antibody (cetuximab or panitumumab), and v-raf murine sarcoma viral oncogene homolog B1 inhibitor/BRAF (encorafenib), if applicable * Patients with MSI-H/dMMR are excluded * ECOG performance status of 0 or 1 * Adequate organ function * Part 1B, Part 1C, and Phase 2 only: measurable disease per iRECIST Exclusion Criteria: * Received prior treatment with anti-CTLA-4 therapy * Received prior immune-checkpoint therapy and experienced Grade 3 or greater toxicity lasting greater than 6 weeks * Received prior approved systemic anticancer therapy within 4 weeks prior to study treatment * Received prior radiotherapy within 2 weeks prior to study treatment * Phase 2 only: Received prior anti-PD-1/L1 therapy or any investigational checkpoint inhibitory therapy * Has a diagnosis of immunodeficiency * Has known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years * Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs * Has an active infection requiring systemic intravenous therapy within 4 weeks prior to study treatment, or oral therapy within 2 weeks prior to study treatment * Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and/or any of its excipients * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Phase 2 only: symptomatic bowel obstruction
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
-
California Cancer Associates for Research and Excellence, cCARE
Encinitas, California, 92024, United States
-
California Cancer Associates for Research and Excellence, cCARE
San Marcos, California, 92069, United States
-
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
-
City of Hope
Duarte, California, 91010, United States
-
City of Hope-Lennar
Irvine, California, 92618, United States
-
City of Hope-Upland
Upland, California, 91786, United States
-
Duke University Medical Center
Durham, North Carolina, 27710, United States
-
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
-
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
-
Mayo Clinic Hospital
Jacksonville, Florida, 32224, United States
-
Mayo Clinic Hospital
Rochester, Minnesota, 55905, United States
-
NEXT Virginia
Fairfax, Virginia, 22031, United States
-
Next Oncology
Austin, Texas, 78758, United States
-
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827, United States
-
Tranquil Clinical Research
Webster, Texas, 77598, United States
-
UCLA Hematology/Oncology- Santa Monica
Santa Monica, California, 90404, United States
-
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
-
University of Pittsburgh Medical Center- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Which drug first? trial tests sequence of carboplatin and olaparib in aggressive prostate cancer
- 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?