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Trial 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
NCT ID:
NCT06480552
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TEV-56278
Description:
Administered intravenously
Arm group label:
TEV-56278 Monotherapy; Dose Escalation
Arm group label:
TEV-56278 Monotherapy; Dose Expansion
Arm group label:
TEV-56278 in Combination with Pembrolizumab; Dose Escalation
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered intravenously
Arm group label:
TEV-56278 in Combination with Pembrolizumab; Dose Escalation
Other name:
KEYTRUDA®
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
- 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 for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Teva Investigational Site 12014
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Facility:
Name:
Teva Investigational Site 12018
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
July 22, 2024
Completion date:
February 25, 2031
Lead sponsor:
Agency:
Teva Branded Pharmaceutical Products R&D, Inc.
Agency class:
Industry
Source:
Teva Branded Pharmaceutical Products R&D, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06480552
