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

NCT06480552
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
240
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Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
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Start date
2024-07-22
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Number of sites
12
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Summary
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).
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Short title
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
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2031-02-25
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First posted
2024-06-28
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Registry last updated
2026-06-04
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Primary completion date
2029-05-26
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Start date
2024-07-22
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Participants
240
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Participant count basis
Estimated
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Planned participants
240
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Protocol amendments
2
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Number of sites
12
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Teva Branded Pharmaceutical Products R&D LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06480552
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ClinicalTrials.gov ID
NCT06480552
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence of AEs with CTCAE Grade≥3 in the escalation phase

    Timeframe: Up to 15 months after 1st infusion in the escalation phase

    CTCAE: Common Terminology Criteria for Adverse Events

  2. Incidence of SAEs in the escalation phase

    Timeframe: Up to 15 months after 1st infusion in the escalation phase

  3. Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase

    Timeframe: Up to 28 days after 1st infusion in the escalation phase

    DLT: dose-limiting toxicity

  4. Incidence of dose modifications due to AEs in the escalation phase

    Timeframe: Up to 12 months after 1st infusion in the escalation phase

  5. Incidence of AEs leading to discontinuation in the escalation phase

    Timeframe: Up to 12 months after 1st infusion in the escalation phase

  6. Recommended Phase 2 dose as monotherapy

    Timeframe: Up to 24 months after 1st infusion

  7. Objective Response Rate (ORR) based on RECIST (v 1.1) criteria in the expansion phase

    Timeframe: Up to 24 months after the 1st dose in the expansion phase

    RECIST: Response Evaluation Criteria in Solid Tumors.

  8. Duration of Response (DOR) in the expansion phase

    Timeframe: Up to 24 months after the 1st dose in the expansion phase

  9. Recommended Phase 2 dose in combination with Pembrolizumab

    Timeframe: Up to 24 months after 1st dose

  10. Incidence of AEs with CTCAE Grade≥3 in the combination phase

    Timeframe: Up to 15 months after 1st infusion in the combination phase

  11. Incidence of SAEs in the combination phase

    Timeframe: Up to 15 months after 1st infusion in the combination phase

  12. Incidence of AEs meeting protocol-defined DLT criteria in the combination phase

    Timeframe: Up to 28 days after 1st infusion in the combination phase

  13. Incidence of dose modifications due to AEs in the combination phase

    Timeframe: Up to 12 months after 1st infusion in the combination phase

  14. Incidence of AEs leading to discontinuation in the combination phase

    Timeframe: Up to 12 months after 1st infusion in the combination phase

  1. AUC0-last

    Timeframe: Predose up to Day 8

    Area under the serum concentration-time curve from time 0 to last measurable drug concentration

  2. Cmax

    Timeframe: Predose up to Day 8

    Maximum observed concentration

  3. tmax

    Timeframe: Predose up to Day 8

    Time to maximum observed drug concentration

  4. Objective Response Rate (ORR) based on RECIST (v1.1) criteria in the escalation phase

    Timeframe: Up to 24 months after 1st infusion in the escalation phase

  5. Incidence of AEs with CTCAE (v5.0) Grade≥3 in the expansion phase

    Timeframe: Up to 24 months after 1st infusion in the expansion phase

  6. Incidence of SAEs in the expansion phase

    Timeframe: Up to 15 months after 1st infusion in the expansion phase

  7. Incidence of dose modifications due to AEs in the expansion phase

    Timeframe: Up to 12 months after 1st infusion in the expansion phase

  8. Incidence of AEs leading to discontinuation in the expansion phase

    Timeframe: Up to 12 months after 1st infusion in the expansion phase

  9. Disease Control Rate (DCR) according to RECIST (v1.1) criteria

    Timeframe: Up to 24 months after 1st infusion

  10. Time to Respond (TTR) according to RECIST (v1.1) criteria

    Timeframe: Up to 24 months after 1st infusion

  11. Objective Response Rate (ORR) based on RECIST criteria in the combination phase

    Timeframe: Up to 24 months after 1st infusion in the combination phase

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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

Sources for eligibility
clinicaltrials.gov

  • Teva Investigational Site 12017Los Angeles, United StatesRecruiting
  • Teva Investigational Site 12021Lake Mary, United StatesCompleted
  • Teva Investigational Site 12016Chicago, United StatesRecruiting
  • Teva Investigational Site 12015Detroit, United StatesRecruiting
  • Teva Investigational Site 12014Huntersville, United StatesRecruiting
  • Teva Investigational Site 12023Cincinnati, United StatesRecruiting
  • Teva Investigational Site 12058Pittsburgh, United StatesRecruiting
  • Teva Investigational Site 12019Nashville, United StatesRecruiting
  • Teva Investigational Site 12024Nashville, United StatesRecruiting
  • Teva Investigational Site 12018Fairfax, United StatesRecruiting
  • Teva Investigational Site 12025Milwaukee, United StatesRecruiting
  • Teva Investigational Site 11282Toronto, CanadaRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-525954-12-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)