Health TrialsbyHealthPanel

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

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTeva Branded Pharmaceutical Products R&D LLC

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • TEV-56278

    Drug

    Administered intravenously

  • Pembrolizumab

    Drug

    Administered intravenously

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part 1: TEV-56278 Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary ResistanceExperimental treatment 1 intervention
Group C: Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary ResistanceExperimental treatment 1 intervention
Group D: Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary ResistanceExperimental treatment 1 intervention
Group E: Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary ResistanceExperimental treatment 1 intervention
Group F: Part 3: TEV-56278 and Pembrolizumab Combination Dose EscalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

CTCAE: Common Terminology Criteria for Adverse Events

Time frame
Up to 15 months after 1st infusion in the escalation phase
2

Incidence of SAEs in the escalation phase

Time frame
Up to 15 months after 1st infusion in the escalation phase
3

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

DLT: dose-limiting toxicity

Time frame
Up to 28 days after 1st infusion in the escalation phase
4

Incidence of dose modifications due to AEs in the escalation phase

Time frame
Up to 12 months after 1st infusion in the escalation phase

Secondary outcomes

1

AUC0-last

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

Time frame
Predose up to Day 8
2

Cmax

Maximum observed concentration

Time frame
Predose up to Day 8
3

tmax

Time to maximum observed drug concentration

Time frame
Predose up to Day 8
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Teva Branded Pharmaceutical Products R&D LLC

Lead sponsor

Source ClinicalTrials.gov
Apply now