Comparing 6 approaches for advanced solid tumors
Official 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
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
- Phase 1
- 6 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
TEV-56278
Administered intravenously
- Medication
Pembrolizumab
Administered intravenously
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Teva Investigational Site 11282
Toronto, Ontario
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → as ineligible for approved standard therapy
- +Have a life expectancy≥12 weeks at the time of the screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +NOTE- Additional criteria apply, please contact the investigator for more information
- +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
Exclusion
- −Has a history of or known active brain metastases and/or carcinomatous meningitis and/or leptomeningeal metastasis
- −Is currently receiving or has received hematopoietic colony-stimulating growth factors within 2 weeks before screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or transfusion support 4 weeks prior to screening
- −Has a diagnosis of immunodeficiency
- −Has active known autoimmune disease.
- −Has active or uncontrolled serious infections requiring systemic therapy within 14 days prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more →
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Groups A, B, C, D and E receive TEV-56278.
Registry label: A: Part 1: TEV-56278 Monotherapy Dose Escalation · B: Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary Resistance · C: Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary Resistance · D: Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary Resistance · E: Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary Resistance
Group F receives Pembrolizumab.
Registry label: F: Part 3: TEV-56278 and Pembrolizumab Combination Dose Escalation
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 240 people.
The study is currently expected to finish around February 2031.
The main measurement is taken over: Up to 15 months after 1st infusion in the escalation phase.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of AEs with CTCAE Grade≥3 in the escalation phase — measured over Up to 15 months after 1st infusion in the escalation phase.
Incidence of SAEs in the escalation phase — measured over Up to 15 months after 1st infusion in the escalation phase.
Incidence of AEs meeting protocolProtocolThe detailed plan a study must follow.Read more →-defined DLT criteria in the escalation phase — measured over Up to 28 days after 1st infusion in the escalation phase.
Incidence of dose modifications due to AEs in the escalation phase — measured over Up to 12 months after 1st infusion in the escalation phase.
The study lists 10 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06480552 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TEV-56278Drug
Administered intravenously
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PembrolizumabDrug
Administered intravenously
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 15 months after 1st infusion in the escalation phase.
The study as a whole is currently expected to finish around 2031-02-25.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 240 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Toronto, Ontario, Canada; Detroit, Michigan, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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).
Other Sites (1)
Teva Investigational Site 12015
Detroit, Michigan, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.