Status:
RECRUITING
Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors
Lead Sponsor:
Xilio Development, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of vilastobart (XTX101) as monotherapy and vilastobart (XTX101) and atezolizumab com...
Detailed Description
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of vilastobart (XTX101), a tumor-selective anti-CTLA-4 antibody, as monotherapy and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04896697
Start Date
September 13 2021
End Date
March 30 2026
Last Update
May 29 2025
Active Locations (19)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
City of Hope
Duarte, California, United States, 91010
3
California Cancer Associates for Research and Excellence, cCARE
Encinitas, California, United States, 92024
4
City of Hope-Lennar
Irvine, California, United States, 92618