Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and atezolizumab combination therapy in patients with advanced solid tumors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

-ECOG performance status of 0 or 1

-Adequate organ function

Part 1B and Part 1C 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 systemic anticancer therapy within 4 weeks prior to study treatment

-Received prior radiotherapy within 2 weeks prior to study treatment

-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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/14/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hao Xie, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jeremy Jones, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20572257

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