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Zanzalintinib and MO-03 for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy

ConditionsMetastatic Clear Cell Renal Cell CarcinomaStage IV Renal Cell Cancer AJCC v8
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase II trial tests how well zanzalintinib and MO-03 works for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progression) after receiving immunotherapy. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. MO-03 is a type of medication called a microbiome-based immunomodulator. It helps control some of the bacteria found in the gut which may make the zanzalintinib more effective. Giving zanzalintinib with MO-03 may be effective for treating metastatic renal cell cancer after progression on immunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of understanding and complying with the protocol requirements and must have signed the informed consent document

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Age: ≥ 18 years

Disqualifiers

Prior treatment with zanzalintinib

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment

Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible

Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03

    Drug

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Zanzalintinib

    Drug

    Given PO

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Treatment (zanzalintinib and MO-03)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Overall response rate

Will be calculated as the number of patients with complete or partial response (per Response Evaluation Criteria in Solid Tumors version 1.1) divided by the total number of treated/evaluable subjects.

Time frame
Up to 2 years

Secondary outcomes

1

Change in gut microbiota composition in stool

Assessed using the proportion of Bifidobacterium spp.

Time frame
From baseline to week 12
2

Microbial diversity

Assessed via comparison of the Shannon index.

Time frame
From baseline to week 12
3

Proportion of circulating regulatory T cells

Will be assessed graphically across serial timepoints of blood collection to ascertain any trends.

Time frame
At baseline, week 9, 13, 17 and 25
4

Proportion of circulating myeloid-derived suppressor cells

Will be assessed graphically across serial timepoints of blood collection to ascertain any trends.

Time frame
At baseline, week 9, 13, 17 and 25

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: