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Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

NCT06760481•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

An open-label, Phase I/Ib study investigating the safety and efficacy of tiragolumab + atezolizumab + RadScopal™ XRT in patients with metastatic solid malignancies.

Detailed Description

Primary Objectives: 1. To evaluate the safety of tiragolumab + atezolizumab + RadScopal™ XRT (Phase I). 2. To evaluate the efficacy of tiragolumab + atezolizumab + RadScopal™ XRT (Phase Ib). Secondary Objectives: 1. To compare the efficacy of tiragolumab + atezolizumab + RadScopal™ XRT to tiragolumab + atezolizumab and atezolizumab + RadScopal™ XRT. 2. To evaluate time-to-event outcomes of tiragolumab + atezolizumab + RadScopal™ XRT.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged ≥18 years at the time of informed consent form signing Patients must have a histologically confirmed metastatic or unresectable solid tumor.
•1. All histological types will be eligible, with preference given to squamous histologies including lung, cervical, head and neck, and esophageal cancers.
•2. Patients must not have available standard of care options or available standard of care option(s) are deemed to be less effective than the clinical trial alternative by the treating physician.
•3. Life expectancy ≤3 months.
•4. Prior anti-PD-1/PD-L1 therapy is allowed.
•5. Patients will be eligible regardless of the number of prior lines of therapy.
•6. Patients must have measurable disease per the RECIST v1.1.
•7. Patients must have at least three active lesions, with at least one lesion amenable to HD-XRT (50 Gy in 4 fractions or 30 Gy in 5 fractions) as determined by the radiation oncologist. Repeat radiation with LD-XRT to previously irradiated sites will be allowed at the discretion of the investigator or treating radiation oncologist.
•8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix A).
•9. Adequate organ and marrow function as defined below:
+22 more criteria

Exclusion Criteria

•History of leptomeningeal disease. ● Uncontrolled tumor-related pain Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
•Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
•* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX®) are allowed.
•* Uncontrolled or symptomatic hypercalcemia (ionized calcium \>1.5 mmo1/L, calcium \>12 mg/dL or corrected serum calcium \> ULN).
•* Active tuberculosis.
•* Received XRT within 14 days prior to study treatment initiation.
•* Received anticancer systemic therapies (including chemotherapy, immunotherapy, targeted therapy, or other modalities such as investigational agents) within 21 days or 5 half-lives of the drug, whichever is shorter.
•* Prior XRT to the target lesion(s) selected for HD-XRT. Previous radiation to LDXRT target lesions is allowed per investigator or treating radiation oncologist discretion.
•* Unresolved Grade ≥2 AEs from prior anticancer therapy. Patients with Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the principal investigator (PI).
•* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or tiragolumab formulation.
+24 more criteria

Locations (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

April 13, 2025

Primary Completion Date

September 15, 2028

Completion Date

September 15, 2030

Last Updated

February 24, 2026

Enrollment

ACTUAL participants

Conditions

Advanced Solid Malignancies

Interventions

Tiragolumab

DRUG

Atezolizumab

DRUG

Radiation Therapy

RADIATION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

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