RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing 177Lu girentuximab for Advanced Cancer

To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).

Official registry: https://clinicaltrials.gov/study/NCT05663710 · M.D. Anderson Cancer Center · enrollment listed as 100

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 177Lu girentuximab, Nivolumab, or Cabozantinib. The registry lists allocation as randomized. To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).

They plan to enroll about 100 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

Interventions: 177Lu girentuximab, Nivolumab, Cabozantinib, ArabinoFuranosylGuanine [18F]F-AraG

Primary outcome (registry wording): Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Who it is for (from inclusion criteria)

Ages 18 Years to any
Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515
Has locally advanced or metastatic RCC with predominantly clear cell subtype
Has at least one measurable lesion as defined by RECIST version 1.1
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Has adequate organ function defined as follows:
Women of child beariring potential must have a negative serum preganancy test within 7 days before first study drug administration
Total abstinence (defined as refraining from heterosexual intercourse during the entire period outlined above),

Who the registry excludes

Has received treatment with any frontline systemic therapy for metastatic RCC
Has a history of leptomeningeal disease or spinal cord compression
Has a history of autoimmune disease requiring active therapy
Has a history of brain metastases except:
Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND
Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs
Has uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure (BP) \> 140/90 with or without antihypertensive treatment

Public study contact (from the registry)

Eric Jonasch, MD

(713) 563-7232

ejonasch@mdanderson.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

MD Anderson Cancer Center — Houston, Texas (recruiting)

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FAQ about this NCT record

Is NCT05663710 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05663710?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05663710?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary