> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-in-patients-with-advanced-cancers-878aa686-dd87-43f4-a2a1-79b39215fbd3 > Record changed: 2026-10-13 # A Study in Patients With Advanced Cancers NCT05320588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) Participants 332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) Lead sponsor BiOneCure Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) Start date 2022-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Title and summary **Summary** A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Short title** A Study in Patients With Advanced Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Official title** A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Dates **Completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **First posted** 2022-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Registry last updated** 2022-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Primary completion date** 2024-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Start date** 2022-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Size and sites **Participants** 332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Planned participants** 332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Lead sponsor** BiOneCure Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Identifiers **Registry ID** NCT05320588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **ClinicalTrials.gov ID** NCT05320588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Outcomes ### Primary outcomes 1. Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) Timeframe: 1 year Escalation period 2. Incidence and nature of dose-limiting toxicities (DLTs) - (Phase 1) Timeframe: up to 21 days Escalation period 3. Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) Timeframe: 1 year Escalation period 4. Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 2) Timeframe: 2 years Expansion period ### Secondary outcomes 1. Anti-tumor activity by objective response rate (ORR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - (Phase 1) Timeframe: 1 year Escalation Period 2. Incidence of adverse event of special interest (AESI) - (Phase 2) Timeframe: 2 years Expansion period 3. Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) Timeframe: 2 years Expansion period 4. PK (Cmax) of BIO-106 - (Phase 1/2) Timeframe: 2 years Escalation and expansion periods 5. PK (AUC) of BIO-106 - (Phase 1/2) Timeframe: 2 years Escalation and expansion periods 6. Incidence of anti-BIO-106 antibodies - (Phase 1/2) Timeframe: 2 years Escalation and expansion periods Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Patients histologically or cytologically documented, locally advanced or metastatic solid tumor. - Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment. - Measurable disease as determined by RECIST v.1.1 or bone only disease. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: - History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody. Impaired cardiac function or history of clinically significant cardiac disease - Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection. - Active SARS-CoV-2 infection. - Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis. Other protocol defined inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Sites - NEXT Oncology AustinAustin, United StatesRecruiting - University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - NEXT Oncology VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05320588) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [BiOneCure Therapeutics Inc.](https://trialight.com/data/company/bionecure-therapeutics-inc-fe3e9e5c-cc3f-4d6a-be96-1370b698e4e2.md) ### Conditions (1) - [Metastatic malignant neoplasm](https://trialight.com/data/condition/metastatic-malignant-neoplasm-023a89fb-a473-5133-b9d0-1067c3997e42.md) Primary condition ### 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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