An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEV-56278, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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 Tumors
Overview
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 (Part 2 only) * 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. Participants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).
Interventions
- Drug TEV-56278
Administered intravenously - Drug Pembrolizumab
Administered intravenously
Primary outcome measures
- Incidence of AEs with CTCAE Grade≥3 in the escalation phase [Time frame: Up to 15 months after 1st infusion in the escalation phase]
- Incidence of SAEs in the escalation phase [Time frame: Up to 15 months after 1st infusion in the escalation phase]
- Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase [Time frame: Up to 28 days after 1st infusion in the escalation phase]
- Incidence of dose modifications due to AEs in the escalation phase [Time frame: Up to 12 months after 1st infusion in the escalation phase]
- Incidence of AEs leading to discontinuation in the escalation phase [Time frame: Up to 12 months after 1st infusion in the escalation phase]
- Recommended Phase 2 dose as monotherapy [Time frame: Up to 24 months after 1st infusion]
- Objective Response Rate (ORR) based on RECIST (v 1.1) criteria in the expansion phase [Time frame: Up to 24 months after the 1st dose in the expansion phase]
- Duration of Response (DOR) in the expansion phase [Time frame: Up to 24 months after the 1st dose in the expansion phase]
- Recommended Phase 2 dose in combination with Pembrolizumab [Time frame: Up to 24 months after 1st dose]
- Incidence of AEs with CTCAE Grade≥3 in the combination phase [Time frame: Up to 15 months after 1st infusion in the combination phase]
Secondary outcome measures (11)
- AUC0-last [Time frame: Predose up to Day 8]
- Cmax [Time frame: Predose up to Day 8]
- tmax [Time frame: Predose up to Day 8]
- Objective Response Rate (ORR) based on RECIST (v1.1) criteria in the escalation phase [Time frame: Up to 24 months after 1st infusion in the escalation phase]
- Incidence of AEs with CTCAE (v5.0) Grade≥3 in the expansion phase [Time frame: Up to 24 months after 1st infusion in the expansion phase]
- Incidence of SAEs in the expansion phase [Time frame: Up to 15 months after 1st infusion in the expansion phase]
- Incidence of dose modifications due to AEs in the expansion phase [Time frame: Up to 12 months after 1st infusion in the expansion phase]
- Incidence of AEs leading to discontinuation in the expansion phase [Time frame: Up to 12 months after 1st infusion in the expansion phase]
- Disease Control Rate (DCR) according to RECIST (v1.1) criteria [Time frame: Up to 24 months after 1st infusion]
- Time to Respond (TTR) according to RECIST (v1.1) criteria [Time frame: Up to 24 months after 1st infusion]
- Objective Response Rate (ORR) based on RECIST criteria in the combination phase [Time frame: Up to 24 months after 1st infusion in the combination phase]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Teva Investigational Site 12017 — Los Angeles
- Teva Investigational Site 12021 — Lake Mary
- Teva Investigational Site 12016 — Chicago
- Teva Investigational Site 12015 — Detroit
- Teva Investigational Site 12014 — Huntersville
- Teva Investigational Site 12023 — Cincinnati
- Teva Investigational Site 12058 — Pittsburgh
- Teva Investigational Site 12019 — Nashville
- … and 3 more centers
Canada · 1 center
- Teva Investigational Site 11282 — Toronto
Identifiers
NCT: NCT06480552 · TV56278-ONC-10203 · 2026-525954-12-00