For Healthcare Professionals

XTX101 Monotherapy and XTX101 and Atezolizumab Combination Therapy in Patients With Advanced Solid Tumors

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About the study

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and atezolizumab combination therapy in patients with advanced solid tumors.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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:

  1. 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.
  2. Patients with metastatic castrate-resistant prostate cancer if they have progressed on at least 2 lines of systemic therapy
  3. Patients with extensive stage small cell lung cancer (SCLC) after at least 1 line of prior therapy
  4. Patients with microsatellite stable colorectal cancer after at least 2 lines of prior therapy
  5. ECOG performance status of 0 or 1
  6. Adequate organ function
  7. Part 1B and Part 1C only: measurable disease per iRECIST

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Received prior treatment with anti-CTLA-4 therapy
  2. Received prior immune-checkpoint therapy and experienced Grade 3 or greater toxicity lasting greater than 6 weeks
  3. Received prior systemic anticancer therapy within 4 weeks prior to study treatment
  4. Received prior radiotherapy within 2 weeks prior to study treatment
  5. Has a diagnosis of immunodeficiency
  6. Has known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years
  7. 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
  8. 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
  9. Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and/or any of its excipients
  10. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Advanced Solid Tumor

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

96

Est. Completion Date

Mar 30, 2026

Treatment type

Interventional


Sponsor

Xilio Development, Inc.

ClinicalTrials.gov identifier

NCT04896697

Study number

XTX101-01/02-001

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