Clareo Health | Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable disease per RECIST version 1.1
Adequate hematology, renal and hepatic function
Left ventricular ejection fraction (LVEF) ≥ 50%
Patients with brain metastases may be enrolled only if treated, nonprogressive, asymptomatic and not taking high dose steroids for at least 4 weeks prior to Cycle 1 Day 1 (C1D1)
Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception, per protocol.
Tissue criteria: must provide sufficient, and adequate tumor tissue sample or agree to have a biopsy taken.
Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor for which no standard therapy is available, standard therapy has failed, or for whom standard-of-care therapy is contraindicated.
Histologically or cytologically confirmed unresectable metastatic or locally advanced disease following treatment for metastatic disease including an immune checkpoint inhibitor and a platinum-containing chemotherapy
Patients with actionable genomic alterations must have also received treatment with at least 1 approved therapy appropriate to the genomic alteration unless unavailable or contraindicated
Histologically or cytologically confirmed disease based on the most recent analyzed biopsy metastatic disease that is refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens, one of which was a taxane (unless contraindicated).
You may not be if
Prior systemic anti-cancer therapy must meet wash-out criteria outlined in protocol
Treatment with any high dose systemic corticosteroids or nonsystemic radiotherapy within 2 weeks of the first dose of zamzetoclax (low dose corticosteroids permitted).
Women who are pregnant or lactating
Patients with active ≥ Grade 2 nausea or vomiting, and/or signs of intestinal obstruction
Known active or chronic hepatitis B or C infection or HIV infection/ HIV positive
Known history of clinically significant cardiovascular disease or heart failure.
Known history of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory illness present within 6 months prior to C1D1
Known history of other clinically significant pulmonary disease or evidence of active pneumonitis
Uncontrolled pleural effusion, pericardial effusion, or ascites
History of clinically significant bleeding, intestinal obstruction, or gastrointestinal (GI) perforation within 6 months prior to C1D1
Infection requiring intravenous anti-infective use within 2 weeks prior to C1D1
Active or history of autoimmune disease or immune deficiency
History of uncured coexisting cancer, not including uncured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer.
Known heart failure or elevated cardiac biomarkers
Known hypersensitivity to excipients in study treatments.
Prior treatment with sacituzumab govitecan-hziy or a topoisomerase 1 inhibitor or agents targeting Trop-2.
