XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT06568562 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCI178937
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how well the study drug XL092 is helping to treat a participant's cancer after 16 weeks of treatment. Researchers will also look at how safe the XL092 is and how well the XL092 is working. XL092 is an oral tablet that will be taken once a day. Participants will return to clinic for regular visits for checkups and tests.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with non-progressive disease after 16 weeks of treatment with XL092 as assessed by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1

  To evaluate the disease control rate at 16 weeks in metastatic castrate-resistant prostate cancer (mCRPC) patients treated with XL092 after progression on 177Lu-PSMA-617

  16 weeks

Secondary Outcomes (7)

• Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.

  5 years

• Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).

  5 years

• Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.

  5 years

• Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.

  5 years

• Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.

  5 years

Study Arms (1)

Treatment: All Patients

EXPERIMENTAL

XL092 is an oral tablet that will be taken once per day on a 28 day cycle. Participants will take a 60mg dose. Dose reductions to 40mg or 20mg may apply for in cases of dose interruption due to treatment-related toxicity.

Drug: XL092

Interventions

XL092 DRUG

XL092 will be supplied as a tablet that will be taken at home once a day. Participants should drink at least 8 ounces of water with each dose of XL092. Participants should not eat at least 2 hours before taking the dose and 1 hour after. Participants will be given enough XL092 to take at home for a full cycle.

Also known as: Zanzalintinib

Treatment: All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged ≥ 18 years
• Disease criteria:
• Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
• Radiographic evidence of metatstatic disease
• Progression on or after prior treatment with 177Lu-PSMA-617 as determined by clinical investigator
• ECOG Performance Status ≤ 2.
• Adequate organ function as defined as:
• Absolute neutrophil count ≥ 1500/mm3 .
• Platelet count ≥ 100,000/mm3 .
• Hemoglobin ≥ 9 g/dL .
• Total Bilirubin ≤ 1.5x institutional ULN. For subject's with Gilbert's disease, ≤ 3 x ULN.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN. For subjects with CRPC and bone metastasis ALP ≤ 10 x ULN if predominantly bone-specific ALP.
• International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 40 mL/min by Cockcroft-Gault formula:
• Males: ((140-age)×weight\[kg\])/(serum creatinine \[mg/dL\]×72)

You may not qualify if:

• Prior treatment with XL092
• Receipt of any type of small molecule kinase inhibitor, cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 2 weeks or at least 5 half-lives, whichever shorter before first dose of study treatment.
• Note: Concomitant use of megestrol acetate, androgen-deprivation therapy and bone loss prevention treatment is permitted. Other types of hormonal therapies with similar use require prior approval from the Principal Investigator.
• Radiation therapy for bone metastasis or any other radiation therapy within 2 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.
• Note: Subjects with an incidental finding of an isolated brain lesion \< 1 cm in diameter may be eligible after Principal Investigator approval if the lesion is radiographically stable for 4 weeks before first dose and does not require treatment per Investigator judgement.
• Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
• Concomitant anticoagulation with oral anticoagulants except for those specified below:-
• (a) Prophylactic use of low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose low molecular weight heparins (LMWH) or prophylactic dose of specified direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban
• (b) Therapeutic doses of LMWH or specified direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before enrollment and without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
• Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks or at least 5 half-lives, whichever shorter before first dose of study treatment.
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
• Cardiovascular disorders:
• Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias \[eg, ventricular flutter, ventricular fibrillation, Torsades de pointes (TdP)\].
• Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment.

Sponsors & Collaborators

• University of Utah: lead
• Exelixis: collaborator

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Study Officials

• Umang Swami, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Sharry

CONTACT

801-585-3453; susan.sharry@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)