Advanced Solid TumorsPhase 1NCT06480552
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 1 study testing TEV-56278 and Pembrolizumab in people with Advanced Solid Tumors, run by Teva Branded Pharmaceutical Products R&D LLC at 12 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TEV-56278 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 22 Jul 2024to 25 Feb 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
United States11 sites, 10 recruiting
- Recruiting
Teva Investigational Site 12016
Chicago, Illinois, 60611
- Recruiting
Teva Investigational Site 12023
Cincinnati, Ohio, 45219
- Recruiting
Teva Investigational Site 12015
Detroit, Michigan, 48201
- Recruiting
Teva Investigational Site 12018
Fairfax, Virginia, 22031
- Recruiting
Teva Investigational Site 12014
Huntersville, North Carolina, 28078
- Completed
Teva Investigational Site 12021
Lake Mary, Florida, 32746
- Recruiting
Teva Investigational Site 12017
Los Angeles, California, 90025
- Recruiting
Teva Investigational Site 12025
Milwaukee, Wisconsin, 53226
- Recruiting
Teva Investigational Site 12019
Nashville, Tennessee, 37203
- Recruiting
Teva Investigational Site 12024
Nashville, Tennessee, 37232
- Recruiting
Teva Investigational Site 12058
Pittsburgh, Pennsylvania, 15232
Canada1 site, 1 recruiting
- Recruiting
Teva Investigational Site 11282
Toronto, Ontario, M5G 2M9
About this study
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
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
Read more
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).
- Conditions
- Advanced Solid Tumors
- Being tested
- TEV-56278, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-56278Drug
Administered intravenously
PembrolizumabDrug
Also called KEYTRUDA®
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part 1: TEV-56278 Monotherapy Dose Escalation | Experimental | Part 1 will be initiated first and will evaluate dose escalation of TEV-56278 as a monotherapy in selected solid tumors Receives: Drug: TEV-56278 |
| Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary Resistance | Experimental | 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. Receives: Drug: TEV-56278 |
| Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary Resistance | Experimental | 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 Receives: Drug: TEV-56278 |
| Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary Resistance | Experimental | 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) Receives: Drug: TEV-56278 |
| Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary Resistance | Experimental | 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) Receives: Drug: TEV-56278 |
| Part 3: TEV-56278 and Pembrolizumab Combination Dose Escalation | Experimental | 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) Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs with CTCAE Grade≥3 in the escalation phase
CTCAE: Common Terminology Criteria for Adverse Events
Measured: Up to 15 months after 1st infusion in the escalation phase
Incidence of SAEs in the escalation phase
Measured: Up to 15 months after 1st infusion in the escalation phase
Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase
DLT: dose-limiting toxicity
Measured: Up to 28 days after 1st infusion in the escalation phase
Incidence of dose modifications due to AEs in the escalation phase
Measured: Up to 12 months after 1st infusion in the escalation phase
Incidence of AEs leading to discontinuation in the escalation phase
Measured: Up to 12 months after 1st infusion in the escalation phase
Recommended Phase 2 dose as monotherapy
Measured: Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST (v 1.1) criteria in the expansion phase
RECIST: Response Evaluation Criteria in Solid Tumors.
Measured: Up to 24 months after the 1st dose in the expansion phase
Duration of Response (DOR) in the expansion phase
Measured: Up to 24 months after the 1st dose in the expansion phase
Recommended Phase 2 dose in combination with Pembrolizumab
Measured: Up to 24 months after 1st dose
Incidence of AEs with CTCAE Grade≥3 in the combination phase
Measured: Up to 15 months after 1st infusion in the combination phase
Incidence of SAEs in the combination phase
Measured: Up to 15 months after 1st infusion in the combination phase
Incidence of AEs meeting protocol-defined DLT criteria in the combination phase
Measured: Up to 28 days after 1st infusion in the combination phase
Incidence of dose modifications due to AEs in the combination phase
Measured: Up to 12 months after 1st infusion in the combination phase
Incidence of AEs leading to discontinuation in the combination phase
Measured: Up to 12 months after 1st infusion in the combination phase
Secondary outcomes (11)
AUC0-last
Area under the serum concentration-time curve from time 0 to last measurable drug concentration
Measured: Predose up to Day 8
Cmax
Maximum observed concentration
Measured: Predose up to Day 8
tmax
Time to maximum observed drug concentration
Measured: Predose up to Day 8
Objective Response Rate (ORR) based on RECIST (v1.1) criteria in the escalation phase
Measured: Up to 24 months after 1st infusion in the escalation phase
Incidence of AEs with CTCAE (v5.0) Grade≥3 in the expansion phase
Measured: Up to 24 months after 1st infusion in the expansion phase
Incidence of SAEs in the expansion phase
Measured: Up to 15 months after 1st infusion in the expansion phase
Incidence of dose modifications due to AEs in the expansion phase
Measured: Up to 12 months after 1st infusion in the expansion phase
Incidence of AEs leading to discontinuation in the expansion phase
Measured: Up to 12 months after 1st infusion in the expansion phase
Disease Control Rate (DCR) according to RECIST (v1.1) criteria
Measured: Up to 24 months after 1st infusion
Time to Respond (TTR) according to RECIST (v1.1) criteria
Measured: Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST criteria in the combination phase
Measured: Up to 24 months after 1st infusion in the combination phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start22 Jul 2024
- Primary completion26 May 2029 (estimated)
- Study completion25 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480552
- Sponsor's protocol ID
- TV56278-ONC-10203
- Other IDs
- 2026-525954-12-00
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480552
- Acronym / sponsor ID
- TV56278-ONC-10203
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 26 May 2029 (estimated)
- Study completion
- 25 Feb 2031 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: TEV-56278 Monotherapy Dose Escalation | Experimental | Drug: TEV-56278Part 1 will be initiated first and will evaluate dose escalation of TEV-56278 as a monotherapy in selected solid tumors |
| Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary Resistance | Experimental | Drug: TEV-56278Part 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. |
| Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary Resistance | Experimental | Drug: TEV-56278Part 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 |
| Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary Resistance | Experimental | Drug: TEV-56278Part 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) |
| Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary Resistance | Experimental | Drug: TEV-56278Part 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) |
| Part 3: TEV-56278 and Pembrolizumab Combination Dose Escalation | Experimental | Drug: PembrolizumabPart 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEV-56278Administered intravenously | Drug | Part 1: TEV-56278 Monotherapy Dose Escalation, Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary Resistance, Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary Resistance, Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary Resistance, Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary Resistance |
| PembrolizumabAlso: KEYTRUDA®Administered intravenously | Drug | Part 3: TEV-56278 and Pembrolizumab Combination Dose Escalation |
Primary outcome
Incidence of AEs with CTCAE Grade≥3 in the escalation phase
Time frame: Up to 15 months after 1st infusion in the escalation phase
CTCAE: Common Terminology Criteria for Adverse Events
Incidence of SAEs in the escalation phase
Time frame: Up to 15 months after 1st infusion in the escalation phase
Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase
Time frame: Up to 28 days after 1st infusion in the escalation phase
DLT: dose-limiting toxicity
Incidence of dose modifications due to AEs in the escalation phase
Time frame: Up to 12 months after 1st infusion in the escalation phase
Incidence of AEs leading to discontinuation in the escalation phase
Time frame: Up to 12 months after 1st infusion in the escalation phase
Recommended Phase 2 dose as monotherapy
Time frame: Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST (v 1.1) criteria in the expansion phase
Time frame: Up to 24 months after the 1st dose in the expansion phase
RECIST: Response Evaluation Criteria in Solid Tumors.
Duration of Response (DOR) in the expansion phase
Time frame: Up to 24 months after the 1st dose in the expansion phase
Recommended Phase 2 dose in combination with Pembrolizumab
Time frame: Up to 24 months after 1st dose
Incidence of AEs with CTCAE Grade≥3 in the combination phase
Time frame: Up to 15 months after 1st infusion in the combination phase
Incidence of SAEs in the combination phase
Time frame: Up to 15 months after 1st infusion in the combination phase
Incidence of AEs meeting protocol-defined DLT criteria in the combination phase
Time frame: Up to 28 days after 1st infusion in the combination phase
Incidence of dose modifications due to AEs in the combination phase
Time frame: Up to 12 months after 1st infusion in the combination phase
Incidence of AEs leading to discontinuation in the combination phase
Time frame: Up to 12 months after 1st infusion in the combination phase
11 secondary outcomes
AUC0-last
Time frame: Predose up to Day 8
Cmax
Time frame: Predose up to Day 8
tmax
Time frame: Predose up to Day 8
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
Incidence of AEs with CTCAE (v5.0) Grade≥3 in the expansion phase
Time frame: Up to 24 months after 1st infusion in the expansion phase
Incidence of SAEs in the expansion phase
Time frame: Up to 15 months after 1st infusion in the expansion phase
Incidence of dose modifications due to AEs in the expansion phase
Time frame: Up to 12 months after 1st infusion in the expansion phase
Incidence of AEs leading to discontinuation in the expansion phase
Time frame: Up to 12 months after 1st infusion in the expansion phase
Disease Control Rate (DCR) according to RECIST (v1.1) criteria
Time frame: Up to 24 months after 1st infusion
Time to Respond (TTR) according to RECIST (v1.1) criteria
Time frame: Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST criteria in the combination phase
Time frame: Up to 24 months after 1st infusion in the combination phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Related trials for Advanced Solid Tumors
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Advanced Stage Solid Tumors
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Active, not recruitingPhase 1/2
A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1
A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors
Advanced-stage Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D LLC
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TEV-56278 and Pembrolizumab in people with Advanced Solid Tumors, run by Teva Branded Pharmaceutical Products R&D LLC at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teva U.S. Medical Information (1-888-483-8279, USMedInfo@tevapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.