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Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

ConditionsUterine CancerEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWashington University School of Medicine

About this trial

The purpose of this study is to determine the recommended Phase 2 dose of zanzalintinib when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer. Other objectives include overall safety and tolerability as well as rates of response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of recurrent, FIGO grade 3 endometrioid, serous, or mixed high grade uterine or endometrial cancer or uterine carcinosarcoma. Patients must have experienced either prior progression on a platinum-based therapy or intolerance to platinum. Patients with dMMR or MSI-H tumors or targetable HER2 alterations are required to have received prior therapy with appropriate targeted agents.

1-2 prior lines of anti-cancer therapy are allowed.

Subjects who have received prior treatment with trastuzumab, pembrolizumab, or dostarlimab can enroll in the study. Use of these agents together or as maintenance therapy is considered 1 regimen.

Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (eg, physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ Grade 2 hypomagnesemia, ≤ Grade 2 neuropathy are permitted)

Disqualifiers

Any prior treatment with zanzalintinib

A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment, or any prior treatment with any tyrosine kinase inhibitor (TKI) or any prior treatment with bevacizumab.

Receipt of any other (non-study) cytotoxic chemotherapy, radiation, targeted treatment, or immunotherapy (including investigational) within 4 weeks prior of start of study treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Zanzalintinib

    Drug

    Taken by mouth.

  • Paclitaxel

    Drug

    175 mg\^m2 intravenous over 3 hours.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Dose Level 2 (Starting Dose): Zanzalintinib + PaclitaxelExperimental treatment 2 interventions
Group B: Dose Level 3: Zanzalintinib + PaclitaxelExperimental treatment 2 interventions
Group C: Dose Level 1 (Reduction): Zanzalintinib + PaclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recommended Phase 2 dose (RP2D)

Time frame
Through completion of first cycle (each cycle is 21 days) of all enrolled patients (estimated to be 48 months and 3 weeks)

Secondary outcomes

1

Frequency and severity of treatment-emergent adverse events

Time frame
From start of treatment through 30 days after last dose of zanzalinitinib (estimated to be 7 months)
2

Overall response rate (ORR)

ORR is defined as the proportion of subjects who have a partial or complete response per RECIST criteria after 3 cycles of treatment with zanzalintinib plus paclitaxel.

Time frame
After 3 cycles of treatment (each cycle is 21 days - estimated to be 63 days)
3

Progression-free survival (PFS)

PFS is defined as the time from start of treatment to the first radiologically documented disease progression, or death, whichever comes first. The alive patients without radiologically documented disease progression are censored at the last follow-up.

Time frame
From start of treatment through completion of follow-up (estimated to be 5.5 years)
4

Overall survival (OS)

OS is defined as the time from start of treatment to death. The alive patients are censored at the last follow-up.

Time frame
From start of treatment through completion of follow-up (estimated to be 5.5 years)

Other outcomes

Sponsors and contacts

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

Washington University School of Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Exelixis

Collaborator

Source ClinicalTrials.gov
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