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New treatment option for Advanced Hepatocellular Carcinoma
Official title Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer
ClinicalTrials.gov ID: NCT07042919
What this study is testing
What is Zanzalintinib?
Zanzalintinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced hepatocellular carcinoma.
Also referred to as Multi-kinase Inhibitor XL092, XL 092.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase Ib/II trial tests the safety, side effects, and best dose of zanzalintinib and how well it works in treating patients with hepatocellular (liver) cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Zanzalintinib is in a class of medications called tyrosine kinase inhibitors.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 3.1.1 Patients with confirmed diagnosed HCC who are not amendable to curative treatments.
- 3.1.2 Patients must have documented objective radiographic progression during or after treatment with any first or second line therapy, or...
- 3.1.3 Patients must have a Child-Pugh class A or Child-Pugh class B (B7 or B8) score for cirrhosis mortality. Child-Pugh class B, B9 is excluded. See...
- 3.1.4 Patients must have measurable disease according to RECIST v1.1. See Section 7 for the evaluation of measurable disease. See Appendix B for...
- 3.1.5 Patients may have had up to two prior lines therapy (not including cabozantinib) in the advanced metastatic setting. Palliative radiation or...
You likely can't join if
- 3.2.1 Patients with prior treatment with zanzalintinib.
- 3.2.2 Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to...
- 3.2.3 Patients who have received ≥ 3 prior therapies in the advanced setting.
- 3.2.4 Patients with prior Cabozantinib use.
- 3.2.5 Patients who have had chemotherapy, cytotoxic, biologic, radiation, or other systemic anticancer (including investigational) therapy within 4...
- 3.2.6 Patients who have received palliative radiation therapy for bone metastasis within 14 days or any other radiation therapy within 4 weeks days...
See the full eligibility criteria
Who can join
- 3.1.1 Patients with confirmed diagnosed HCC who are not amendable to curative treatments.
- 3.1.2 Patients must have documented objective radiographic progression during or after treatment with any first or second line therapy, or intolerance to any first or second line therapy, which include...
- 3.1.3 Patients must have a Child-Pugh class A or Child-Pugh class B (B7 or B8) score for cirrhosis mortality. Child-Pugh class B, B9 is excluded. See Appendix A for Child-Pugh Class Scores.
- 3.1.4 Patients must have measurable disease according to RECIST v1.1. See Section 7 for the evaluation of measurable disease. See Appendix B for RECIST v1.1 criteria.
- 3.1.5 Patients may have had up to two prior lines therapy (not including cabozantinib) in the advanced metastatic setting. Palliative radiation or locoregional therapies are not considered a line of therapy.
- 3.1.6 Patients must be age ≥ 18 years.
- 3.1.7 Patients must exhibit a/an ECOG Status of 0-1 Refer to Appendix C; (Karnofsky ≥ 60%. See Appendix D.)
- 3.1.8 Patients must have adequate organ and bone marrow function as defined below in Table 2 (Child-Pugh Class A): Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets (PLT) ≥ 75,000/mcL...
- 3.1.8 Patients must have adequate organ and bone marrow function as defined below in Table 2 (Child-Pugh Class B): Absolute neutrophil count (ANC) ≥ 1,200/mcL, Hemoglobin (Hgb) ≥ 8.5 g/dL, Platelets (PLT) ≥ 60,000/mcL...
- 3.1.9 POCBP and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception (defined in Appendix E) throughout the course of the study and for 186 days...
- 3.1.10 Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), refer to...
- 3.1.11 POCBP must agree to use a highly effective method of contraception (defined in Appendix E) throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method...
- 3.1.12 Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements.
- 3.1.13 Patients must have the ability to swallow, retain, and absorb oral medications or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.
What rules you out
- 3.2.1 Patients with prior treatment with zanzalintinib.
- 3.2.2 Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study Day 1 treatment.
- 3.2.3 Patients who have received ≥ 3 prior therapies in the advanced setting.
- 3.2.4 Patients with prior Cabozantinib use.
- 3.2.5 Patients who have had chemotherapy, cytotoxic, biologic, radiation, or other systemic anticancer (including investigational) therapy within 4 weeks prior to study Day 1 treatment.
- 3.2.6 Patients who have received palliative radiation therapy for bone metastasis within 14 days or any other radiation therapy within 4 weeks days before first dose of study treatment.
- 3.2.7 Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment.
- 3.2.8 Patients who have received any local anticancer therapy including surgery, PEI, RFA, MWA, transarterial chemoembolization (TACE), or trans arterial radioembolization (TARE) within 28 days prior to first dose of...
- 3.2.9 Patients with any unresolved toxicity NCI Common Terminology Criteria for Adverse Event (CTCAE 5.0) Grade \>1 at baseline, including immune-related adverse events (irAEs), related to any prior treatments, unless...
- 3.2.10 Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made: 1)For patients...
- 3.2.11 Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 28 days prior to first dose of study...
- 3.2.12 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to zanzalintinib.
- 3.2.13 Patients who are on concomitant anticoagulation therapy with oral anticoagulants (e.g., warfarin or direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the...
- 3.2.14 Patients who are taking any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study with in 2 weeks prior to cycle 1 day 1. Note: Taking...
- 3.2.15 Patient has uncontrolled, significant intercurrent or recent illness.
- 3.2.16 Patients with clinically significant hematuria, hematemesis, or hemoptysis of \>0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to...
- 3.2.17 Patients with symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).
- 3.2.18 Patients with lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta. Note: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein...
- 3.2.19 Patients with other clinically significant disorders that would preclude safe study participation
- 3.2.20 Patients with Recent surgery within the following parameters: Major surgery (e.g., GI surgery or removal/biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Prior laparoscopic...
- 3.2.21 Patients with corrected QT interval calculated by the Fridericia formula (QTcF) \>480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment. Note: Triplicate ECG evaluations will be...
- 3.2.22 Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because zanzalintinib is a next-generation TKI with potential...
- 3.2.23 Patients with psychiatric illness/social situations that would limit compliance with study requirements or give informed consent, per the opinion of the treating investigator.
- 3.2.24 Patients with other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.
- 3.2.25 Patients with documented hepatic encephalopathy (HE) within 6 weeks before first dose of study treatment. Patients with clinically meaningful ascites (i.e., ascites requiring paracentesis or escalation in...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.