> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-open-label-dose-escalation-expansion-trial-to-evaluate-94e2b348-c15d-4904-b66b-5b8eef180f22 > Record changed: 2026-10-13 # 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 NCT06480552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) Lead sponsor Teva Branded Pharmaceutical Products R&D LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) Start date 2024-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Title and summary **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 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Dates **Completion date** 2031-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **First posted** 2024-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Registry last updated** 2026-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Primary completion date** 2029-05-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Start date** 2024-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Lead sponsor** Teva Branded Pharmaceutical Products R&D LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Identifiers **Registry ID** NCT06480552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **ClinicalTrials.gov ID** NCT06480552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Outcomes ### Primary outcomes 1. Incidence of AEs with CTCAE Grade≥3 in the escalation phase Timeframe: Up to 15 months after 1st infusion in the escalation phase CTCAE: Common Terminology Criteria for Adverse Events 2. Incidence of SAEs in the escalation phase Timeframe: Up to 15 months after 1st infusion in the escalation phase 3. Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase Timeframe: Up to 28 days after 1st infusion in the escalation phase DLT: dose-limiting toxicity 4. Incidence of dose modifications due to AEs in the escalation phase Timeframe: Up to 12 months after 1st infusion in the escalation phase 5. Incidence of AEs leading to discontinuation in the escalation phase Timeframe: Up to 12 months after 1st infusion in the escalation phase 6. Recommended Phase 2 dose as monotherapy Timeframe: Up to 24 months after 1st infusion 7. Objective Response Rate (ORR) based on RECIST (v 1.1) criteria in the expansion phase Timeframe: Up to 24 months after the 1st dose in the expansion phase RECIST: Response Evaluation Criteria in Solid Tumors. 8. Duration of Response (DOR) in the expansion phase Timeframe: Up to 24 months after the 1st dose in the expansion phase 9. Recommended Phase 2 dose in combination with Pembrolizumab Timeframe: Up to 24 months after 1st dose 10. Incidence of AEs with CTCAE Grade≥3 in the combination phase Timeframe: Up to 15 months after 1st infusion in the combination phase 11. Incidence of SAEs in the combination phase Timeframe: Up to 15 months after 1st infusion in the combination phase 12. Incidence of AEs meeting protocol-defined DLT criteria in the combination phase Timeframe: Up to 28 days after 1st infusion in the combination phase 13. Incidence of dose modifications due to AEs in the combination phase Timeframe: Up to 12 months after 1st infusion in the combination phase 14. Incidence of AEs leading to discontinuation in the combination phase Timeframe: Up to 12 months after 1st infusion in the combination phase ### Secondary outcomes 1. AUC0-last Timeframe: Predose up to Day 8 Area under the serum concentration-time curve from time 0 to last measurable drug concentration 2. Cmax Timeframe: Predose up to Day 8 Maximum observed concentration 3. tmax Timeframe: Predose up to Day 8 Time to maximum observed drug concentration 4. Objective Response Rate (ORR) based on RECIST (v1.1) criteria in the escalation phase Timeframe: Up to 24 months after 1st infusion in the escalation phase 5. Incidence of AEs with CTCAE (v5.0) Grade≥3 in the expansion phase Timeframe: Up to 24 months after 1st infusion in the expansion phase 6. Incidence of SAEs in the expansion phase Timeframe: Up to 15 months after 1st infusion in the expansion phase 7. Incidence of dose modifications due to AEs in the expansion phase Timeframe: Up to 12 months after 1st infusion in the expansion phase 8. Incidence of AEs leading to discontinuation in the expansion phase Timeframe: Up to 12 months after 1st infusion in the expansion phase 9. Disease Control Rate (DCR) according to RECIST (v1.1) criteria Timeframe: Up to 24 months after 1st infusion 10. Time to Respond (TTR) according to RECIST (v1.1) criteria Timeframe: Up to 24 months after 1st infusion 11. Objective Response Rate (ORR) based on RECIST criteria in the combination phase Timeframe: Up to 24 months after 1st infusion in the combination phase Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Sites - Teva Investigational Site 12017Los Angeles, United StatesRecruiting - Teva Investigational Site 12021Lake Mary, United StatesCompleted - Teva Investigational Site 12016Chicago, United StatesRecruiting - Teva Investigational Site 12015Detroit, United StatesRecruiting - Teva Investigational Site 12014Huntersville, United StatesRecruiting - Teva Investigational Site 12023Cincinnati, United StatesRecruiting - Teva Investigational Site 12058Pittsburgh, United StatesRecruiting - Teva Investigational Site 12019Nashville, United StatesRecruiting - Teva Investigational Site 12024Nashville, United StatesRecruiting - Teva Investigational Site 12018Fairfax, United StatesRecruiting - Teva Investigational Site 12025Milwaukee, United StatesRecruiting - Teva Investigational Site 11282Toronto, CanadaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## References ### Other registry identifiers - 2026-525954-12-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06480552) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Teva Branded Pharmaceutical Products R&D, Inc.](https://trialight.com/data/company/teva-branded-pharmaceutical-products-r-d-inc-eb709623-d4a9-423d-9161-7b0540fb1b17.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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