TEV-56278 + Pembrolizumab for Cancer

Recruiting at 10 trial locations

Overseen By Teva U.S. Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Must not be taking: Steroids, Antiepileptics

Disqualifiers: Immunodeficiency, Autoimmune disease, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new cancer treatment called TEV-56278, both alone and in combination with pembrolizumab (KEYTRUDA), to assess its safety and effectiveness. It targets individuals with specific solid tumors who have exhausted other treatments or for whom standard therapies are unsuitable. Those with a solid tumor and no remaining standard therapy options might find this trial suitable. Participants will receive treatment for up to a year, followed by another year of follow-up checks. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have had certain treatments or therapies recently. It's best to discuss your specific medications with the trial investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have tested TEV-56278 both alone and with pembrolizumab, focusing on safety and tolerability. Although exact numbers are unavailable, the research aims to determine the right dose and monitor side effects.

Pembrolizumab alone can cause immune-related side effects, such as inflammation. However, its safe use in other conditions reassures its overall safety in humans.

As this trial is in an early phase, it primarily checks safety and determines the best dose. A complete safety profile for TEV-56278 is not yet available, but these early trials are designed to identify major issues. Participants receive close monitoring to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TEV-56278 because it offers a fresh approach to cancer treatment by targeting specific pathways that current therapies might overlook. Unlike standard treatments like chemotherapy, which can affect both healthy and cancerous cells, TEV-56278 is designed to work more selectively, potentially reducing side effects. When combined with Pembrolizumab, a well-established immunotherapy, TEV-56278 might enhance the body's immune response against cancer cells, offering a promising new option for patients. This combination and the novel mechanism of action are why there's a buzz around its potential in treating cancer more effectively.

What evidence suggests that this trial's treatments could be effective for cancer?

Studies have shown that TEV-56278 targets a specific part of the immune system to help fight cancer. In early tests, TEV-56278 alone caused tumors to shrink, suggesting it might aid the body in combating cancer. In this trial, some participants will receive TEV-56278 as monotherapy, while others will receive it combined with pembrolizumab. Pembrolizumab, already used for cancers like lung cancer and melanoma, enhances the immune system's ability to recognize and attack tumors. Combining TEV-56278 with pembrolizumab could be even more effective, potentially strengthening the body's natural ability to fight cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

This trial is for people with advanced or metastatic solid tumors. Participants will be treated and followed up for a total of up to 25 months. Specific eligibility details are not provided, but typically include factors like age, health status, type of tumor, and prior treatments.

Inclusion Criteria

Have a life expectancy≥12 weeks at the time of the screening

My cancer has worsened despite standard treatments, or I can't tolerate them.

I agree to use effective birth control during and for 4 months after the trial.

Exclusion Criteria

Has active known autoimmune disease

I haven't had serious infections needing treatment in the last 2 weeks.

I am on medication for seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TEV-56278 as monotherapy or in combination with pembrolizumab for up to 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• TEV-56278

Trial Overview The trial is testing TEV-56278 alone and in combination with Pembrolizumab to see how safe they are and how well they work against tumors. The study aims to find the best dose that's effective yet tolerable.

How Is the Trial Designed?

Group I: TEV-56278 in Combination with Pembrolizumab; Dose Escalation Experimental Treatment 2 Interventions

Group II: TEV-56278 Monotherapy; Dose Expansion Experimental Treatment 1 Intervention

Group III: TEV-56278 Monotherapy; Dose Escalation Experimental Treatment 1 Intervention

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Published Research Related to This Trial

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.

In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. Hersey, P., Gowrishankar, K.[2017]

Pembrolizumab (Keytruda) was approved by the FDA for treating metastatic non-small cell lung cancer (mNSCLC) in patients with tumors expressing PD-L1, showing significant improvements in overall survival (OS) and progression-free survival (PFS) in two major clinical trials with thousands of participants.

In the KEYNOTE-024 trial, pembrolizumab demonstrated a 40% reduction in the risk of death compared to chemotherapy, while in the KEYNOTE-010 trial, it also showed a significant survival advantage over chemotherapy in patients who had previously progressed on treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating unresectable or metastatic melanoma based on two clinical trials involving 1,374 patients, showing significant improvements in overall survival compared to ipilimumab, with hazard ratios indicating a reduced risk of death.

Patients receiving pembrolizumab also experienced significant improvements in progression-free survival, although some immune-mediated adverse reactions like hypothyroidism and pneumonitis were noted, highlighting the importance of monitoring for side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. Barone, A., Hazarika, M., Theoret, MR., et al.[2022]

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Pembrolizumab (Keytruda) effectively blocks the PD-1 pathway, enhancing T-cell activity against tumors, which supports its role in promoting tumor regression and immune rejection.

Preclinical studies in cynomolgus monkeys showed that pembrolizumab has a favorable safety profile with no significant toxicological findings, aligning with its demonstrated safety and efficacy in human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab. Hutchins, B., Starling, GC., McCoy, MA., et al.[2021]

Pembrolizumab (Keytruda) is the first anti-PD-1 therapy approved in the US for treating advanced malignant melanoma, specifically for patients who have progressed after prior treatments.

It is designed to target the PD-1 protein, enhancing the immune system's ability to fight cancer, and is currently under review for approval in the EU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab: first global approval. Poole, RM.[2021]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e14506

Multiomic evaluation of TEV-56278, a PD-1-targeted ... This study confirms that TEV-56278 targets IL-2 activity to PD-1 expressing T cells within the tumor microenvironment and induces strong immune response.

2. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Fosun-Pharma-Enter-into-a-Strategic-Partnership-to-Develop-Novel-Anti-PD1-IL2-Therapy-TEV-56278-in-Immuno-Oncology/default.aspx

Teva and Fosun Pharma Enter into a Strategic Partnership ... TEV-56278 is being evaluated as a monotherapy and in combination with pembrolizumab. Preclinical data has demonstrated tumor regression, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06480552

Study Details | NCT06480552 | An Open-label Dose ... The primary objectives of this trial are to: Characterize the safety and tolerability of TEV-56278; Determine the Recommended Phase 2 Dose (RP2D) ...

4. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/TV56278-ONC-10203

TEV-56278 as a Monotherapy and in Combination With ... TEV-56278 may potentially help the immune system target and fight cancer cells directly at the tumor site and possibly enhance the body's natural defense ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/507384

An Open-label Dose Escalation/Expansion Trial to Evaluate the ... 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 ...

6. synapse.patsnap.com synapse.patsnap.com/drug/33e5883b359644bc89f9bcafd2abe718

TEV-56278 - Drug Targets, Indications, Patents 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 ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-07336

An Open-label Dose Escalation/Expansion Trial to ... An open-label dose escalation/expansion trial to evaluate the safety and anti-tumor activity of TEV-56278 alone or in combination with pembrolizumab.

8. tevapharm.com tevapharm.com/teva-clinical-trials/clinical-trials-results/clinical-trials/tv56278onc10203

Safety and Activity of TEV-56278, as a Monotherapy and ... Study Title: A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety and Activity of TEV-56278, ...