A Phase 1A/1B Open-Label, Multicenter, Dose Escalation, And Dose Expansion Trial To Evaluate The Safety And Activity Of Tev-56278, As A Monotherapy And In Combination With Pembrolizumab In Participants With Selected Locally Advanced Or Metastatic Solid Tu
Posted Date: May 19, 2025
- Investigator: Jennifer Leddon
- Type of Study: Drug
The primary objectives of this trial are to: Characterize the safety and tolerability of TEV-56278 Determine the Recommended Phase 2 Dose (RP2D) Evaluate antitumor activity of TEV-56278 Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab Determine a RP2D of TEV-56278 in combination with pembrolizumab The secondary objectives of this trial are to: Characterize the serum pharmacokinetics of TEV-56278 Evaluate the antitumor activity of TEV-56278 Determine the safety and tolerability of TEV-56278 Evaluate other measures of antitumor activity of TEV-56278 Evaluate anti-tumor activity Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.
Criteria:
Inclusion Criteria: Have An Established Histological Diagnosis Of Selected Solid Tumor And Must Have Received And Progressed On Established Standard Therapies Or Have Been Intolerant To Such Therapy Or Have Been Considered By The Investigator As Ineligible For Approved Standard Therapy Have A Life Expectancy=12 Weeks At The Time Of The Screening Women Of Childbearing Potential Must Agree To Use Highly Effective Methods Of Contraception For The Course Of The Trial Through 120 Days After The Last Dose Of Trial Medication Males Who Are Sexually Active With Women Of Childbearing Potential Must Agree To Use Condoms And Refrain From Donating Sperm For The Course Of The Trial Through 120 Days After The Last Dose Of Trial Medication Note- Additional Criteria Apply, Please Contact The Investigator For More Information Exclusion Criteria: Has A History Of Systemic Treatment Therapy For Cancer (Including Chemotherapy, Immunotherapy, Radiotherapy, Or Other Investigational Drug) Or Surgery Within 4 Weeks Prior To Baseline Is Currently Receiving Or Has Received Hematopoietic Colony-Stimulating Growth Factors Within 2 Weeks Before Screening Or Transfusion Support 4 Weeks Prior To Screening Has A Diagnosis Of Immunodeficiency Has Active Known Autoimmune Disease. Has A History Of Or Known Active Brain Metastases And/Or Carcinomatous Meningitis And/Or Leptomeningeal Metastasis Has Active Or Uncontrolled Serious Infections Requiring Systemic Therapy Within 14 Days Prior To Baseline Has A History Of Clinically Significant Cardiovascular Or Cerebrovascular Disease In Previous 6 Months Prior To Screening Has Evidence Of Clinically Significant Interstitial Lung Disease Or Active, Noninfectious Pneumonitis Has A Seizure Disorder Requiring Therapy (Such As Steroids Or Antiepileptics) Note- Additional Criteria Apply, Please Contact The Investigator For More Information
Keywords:
Neoplasms, Antineoplastic Agents, Immunological, Immune Checkpoint Inhibitors
For More Information:
Kayla Webb
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cancer@uchealth.com