Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 2: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Conditions
Interventions
Intervention1: Lintuzumab-Ac225: Patients enrolled in the study administered with 3 cycles of 6 weekly Lintuzumab-Ac225
If body weight exceeds ideal body weight (IBW), Lintuzumab-Ac225 dose will be ca
Sponsors
Actinium Pharmaceutical Inc.
Eligibility
Inclusion criteria
Inclusion criteria: - ECOG PS less than or equal to 2 - Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy - Expression of PD-L1 must have been determined with a validated method or tumor sample must be available for PD-L1 expression determination. - Have measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1. - Prior immunotherapies are allowed. - For subjects with NSCLC, the following criteria should be met - Patients with stage IV NSCLC or locally advanced (stage III) NSCLC when not candidates for surgical resection or definitive chemoradiation, or after local failure of these modalities. Known expressing PD-L1 [Tumor Proportion Score (TPS) treated than or equal to 1 percent] as determined by an FDA-approved test. - Disease progression on or after platinum-containing chemotherapy - Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving the study treatment. - For subjects with HNSCC, the following criteria should be met - Patients with metastatic or with unresectable, recurrent HNSCC whose tumors express - PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by an FDA-approved test - Patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy - Patients enrolled in the study must have disease sites amenable to biopsies and agree to a tumor biopsy to be obtained during the screening period and the study period - Subjects must have normal organ and marrow function as defined below - Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) greater than or equal to 40 mL/min - (if using the Cockcroft-Gault formula below): i. Female CrCl equal to ((140 - age in years) x weight in kg x 0.85) / (72 x serum creatinine in mg/dL) ii. Male CrCl equal to ((140 - age in years) x weight in kg x 1.00) / (72 x serum creatinine in mg/dL) - Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 3 x the ULN, or less than 5 x ULN, if liver metastases are present - Total bilirubin less than or equal to 1.5 x ULN OR in subjects with Gilberts syndrome, a total bilirubin less than or equal to 3.0 x ULN - Hematological eligibility parameters (within 14 days of starting therapy)- Platelet count greater than or equal to 100000/microlitre. Absolute neutrophil count (ANC) greater or equal to 1/microlitre -Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to trial entry and for the duration of trial participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, she should inform her treating physician immediately. -Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of ß-human choriogonadotropin (HCG)) at screening. They must have confirmation by a negative urine pregnancy test within 24 hours prior to the first dose of the study treatment.
Exclusion criteria
Exclusion criteria: - Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 2 weeks prior to first dose of Lintuzumab-Ac225 - Major trauma or major surgery within 2 weeks prior to first dose of Lintuzumab-Ac225 - There is less than 2 weeks from administration of any prior antibody therapies (such as ipilimumab or Anti-PD-1/PD-L1 antibody) prior to the first dose of Lintuzumab-Ac225 - Other concurrent investigational agents (subjects are eligible to enroll 2 weeks after completion of prior investigational agent). - Patients with metastatic lesions in the brain, unless definitively treated and patient is asymptomatic and not on steroids for brain metastases. - Concurrent chronic use of systemic steroids, except for physiologic doses of systemic steroids for replacement, defined as 20 mg of prednisone per day or equivalent, or local (topical, nasal, ophthalmic or inhaled) steroid use or prior concomitant use with chemotherapy. - Systemic steroids must have been discontinued = 2 weeks prior to first treatment. Prior use of corticoids in short-term schemes (duration shorter than 3 days) for indications such as prophylaxis of reactions to intravenous contrast for imaging studies or chemotherapy-related AEs are not considered part of this exclusion. - Prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade = 3 drug-related CNS toxicity - Pregnant or breastfeeding women. - Clinically significant cardiomyopathy, coronary disease, heart failure New York Heart Association class III or IV, or cerebrovascular accident within 1 year. - Uncontrolled intercurrent illness, which would interfere with the ability of the subject to carry out the treatment program. - Any other condition, which would, in the opinion of the Principal Investigator or Medical Monitor, indicate the subject is a poor candidate for the study treatment or would jeopardize the subject or the integrity of the data obtained. - Medical or psychological impediment to compliance with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: - Treatment-emergent adverse events if any - Treatment-related adverse events if any - Clinically significant changes in Vital signs, Physical examinations, Electrocardiogram (ECGs), and clinical laboratory testsTimepoint: Safety: within 4Hrs of infusion, Day 2, Day 4, Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed per RECIST 1.1 criteriaTimepoint: 30 Days;Progression Free SurvivalTimepoint: Not Applicable;Ovarall SurvivalTimepoint: Not Applicable;PK parameters of Lintuzumab-Ac225 includingTimepoint: 30 Days | — |
Countries
India
Contacts
Public ContactSandip Bali
Healthcare Global Enterprises Ltd
Outcome results
None listed