None listed
Conditions
Interventions
investigational material(s)
Generic name etc : telisotuzumab vedotin
INN of investigational material : Telisotuzumab vedotin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administr
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Advanced non-small cell lung cancer (NSCLC), for which surgical resection is not indicated or for which there are no other approved therapeutic options with demonstrated clinical benefit. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Confirmed availability of fresh and/or archival FFPE tumor tissue for analysis. - Adequate bone marrow, renal, and hepatic function. - Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting treatment. - Subjects in Combinations A and D must be able to receive erlotinib or nivolumab per current prescribing information or investigator discretion. - Subjects in Combination E must meet the following criteria:. - Metastatic/locally advanced non-squamous NSCLC with documented EGFR del19 or L858R mutation and no EGFR mutation known to be resistant to osimertinib, with or without the T790 M mutation. Subject must have received at least -1 but not more than 2 prior lines of therapy, of which osimertinib must be one. Disease progression on osimertinib. Prior chemotherapy should be limited to 1 regimen. Consecutive EGFR TKI treatments are counted as 1 regimen. - Patients with tumor tissue beyond progression for central c-Met immunohistochemistry (IHC) testing. - Adequate bone marrow function.
Exclusion criteria
Exclusion criteria: - Radiation therapy to the lung within 6 months prior to the first dose of ABBV-399. - Antineoplastic therapy including chemotherapy, radiation therapy, immunotherapy, and biologics within 21 days before the first dose of ABBV-399, or herbal therapy within 7 days before the first dose. - Participants with uncontrolled CNS metastases by head CT or MRI.Participants with brain metastases may be eligible within 2 weeks of definitive treatment for all known CNS disease sites provided they are asymptomatic, have not had their systemic steroids interrupted or increased in dose (continued during the 2 weeks), and have not received anticonvulsants for seizure activity directly related to progressive CNS metastases. - History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or active ILD or pneumonitis. - Evidence of pulmonary fibrosis on imaging at screening, or history of pneumonitis or interstitial lung disease (ILD) within 3 months of planned first dose of investigational product. - Have unresolved clinically significant adverse events Grade 2 and higher from prior anticancer therapy except for alopecia or anemia. - Major surgery within 21 days before the first dose of ABBV-399. - Clinically significant conditions as listed in the protocol. - History of major immunologic reaction to immunoglobulin G (IgG) -containing products. - Any medical condition that, in the opinion of the Investigator or Medical Monitor, places the subject at an unacceptably high risk for toxicities. - Female patients who are lactating or pregnant. - Subject has known active COVID-19 infection. Participants with signs/symptoms associated with COVID-19 infection or known exposure to a confirmed COVID-19 case in the 14 days prior to screening: - In addition to the exclusion criteria listed above, subjects enrolled in the combination period must also meet the following criteria:. * ABBV-399 in combination with osimertinib, erlotinib, or nivolumab should not be administered to subjects with a medical condition where, in the opinion of the investigator, the risk of toxicity from the combination is unacceptably high. - Nivolumab should not be administered in the following instances: - Active autoimmune disease, except for vitiligo, type I diabetes mellitus, hypothyroidism, and psoriasis. - Corticosteroids (10 mg/day prednisone or equivalent) within 14 days before investigational product infusion >) or systemic use of other immunosuppressive agents. Inhaled, locally injected or topical steroids are excluded. * Known immunosuppressive disorders (e.g., human immunodeficiency virus infection, prior bone marrow transplantation, or chronic lymphocytic leukemia). - Do not enroll in Arm E with osimertinib if: * History of hypersensitivity to the active substance or to any of the excipients. Dose reduction of osimertinib to 470 ms, b) clinically significant abnormalities in the rhythm, conduction, or morphology of the resting ECG (Example: Complete left bundle branch block, 2nd or 3rd degree heart block, PR interval > 250 ms), c) factors that increase the risk for QTc prolongation or arrhythmias, such as heart failure, hy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Pharmacokinetics - Number of subjects with adverse events An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. - Recommended Phase 2 Dose (RPTD) of ABBV-399 as Monotherapy and in Combination with Osimertinib, Erlotinib, or Nivolumab The RPTD of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, or nivolumab will be determined during the dose escalation part of this study. The RPTD will be determined using available safety and pharmacokinetic data. - The AUC from time 0 to the time of the last quantifiable concentration (0-t) [evaluation period: up to 24 months] AUC (0-t) = area under the serum concentration-time curve from time zero (pre-dose) to the last measurable concentration. - Maximum plasma concentration (Maximum observed plasma concentration: Cmax) (evaluation period: up to 24 months) Maximum observed plasma concentration (Cmax) - Time to maximum plasma concentration (Tmax) (evaluation period: up to 24 months) Time to maximum plasma concentration (Tmax) - Apparent elimination half-life (evaluation period: up to 24 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - Overall response rate (ORR) (evaluation period: up to 24 months) ORR is defined as the proportion of subjects with a complete response (CR) or partial response (PR). - Progression-free survival (PFS) (evaluation period: up to 24 months) PFS is defined as the time from the date of first dose of ABBV-399 to the date of disease progression or death, whichever occurs first. - DOR (evaluation period: up to 24 months) DOR is defined as the time from the subject's first CR or PR to disease progression. | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed