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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Teva Branded Pharmaceutical Products R&D LLC
Study ID
NCT06480552
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TEV-56278 — DRUG
    Administered intravenously
  • Pembrolizumab — DRUG
    Administered intravenously

Study Details

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).

Key Dates

Start date
Jul 22, 2024
Status verified
Jun 2026
Primary completion
May 26, 2029
Completion
Feb 25, 2031

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: TEV-56278 Monotherapy Dose Escalation
    Part 1 will be initiated first and will evaluate dose escalation of TEV-56278 as a monotherapy in selected solid tumors
  • Experimental: Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary Resistance
    Part 2 Cohort A will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in non-small cell lung carcinoma (NSCLC) (primary and secondary resistant to anti-PD-(L)1). EU participants will only be included in Part 2.
  • Experimental: Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary Resistance
    Part 2 Cohort B will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1) Only Cohort B will be randomized
  • Experimental: Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary Resistance
    Part 2 Cohort C will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1)
  • Experimental: Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary Resistance
    Part 2 Cohort D will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1)
  • Experimental: Part 3: TEV-56278 and Pembrolizumab Combination Dose Escalation
    Part 3 will be initiated at the discretion of the Sponsor, after some or all of the dose levels in Part 1 have been explored. Part 3 will evaluate escalating doses of TEV-56278 in combination with a fixed dose of pembrolizumab (400 mg Q6W) and include dose escalation in selected solid tumors (same indications as in Part 1)

Primary Outcome Measure

Incidence of AEs with CTCAE Grade≥3 in the escalation phase [ Time Frame: Up to 15 months after 1st infusion in the escalation phase ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Teva Investigational Site 12017Los AngelesCalifornia90025-
Teva Investigational Site 12021Lake MaryFlorida32746-
Teva Investigational Site 12016ChicagoIllinois60611-
Teva Investigational Site 12015DetroitMichigan48201-
Teva Investigational Site 12014HuntersvilleNorth Carolina28078-
Teva Investigational Site 12023CincinnatiOhio45219-
Teva Investigational Site 12058PittsburghPennsylvania15232-
Teva Investigational Site 12019NashvilleTennessee37203-
Teva Investigational Site 12024NashvilleTennessee37232-
Teva Investigational Site 12018FairfaxVirginia22031-
Teva Investigational Site 12025MilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By research site
Teva Investigational· Los Angeles, CATeva Investigational· Lake Mary, FLTeva Investigational· Chicago, ILTeva Investigational· Detroit, MITeva Investigational· Huntersville, NCTeva Investigational· Cincinnati, OH

Related Studies