Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastat… (NCT06234397) | Clinical Trial Compass
RecruitingPhase 1
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
United States, South Korea245 participantsStarted 2023-12-28
Plain-language summary
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
* PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).
* Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Age of 18 years or older (or country's legal age of majority if the legal age was \>18 years)
* Adequate Hematologic and liver function.
Key Exclusion Criteria:
* Has received prior therapy with an anti-4-1BB(CD137) agent.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy that is progressing or has required active treatment.
* History of chronic liver disease or evidence of hepatic cirrhosis.
* History of severe toxicities associated with a prior immunotherapy.
* Has ongoing or suspected autoimmune disease.
* Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Timeframe: Throughout the study until end of safety follow-up period (90 days after the last treatment)
2
Incidence and nature of DLTs
Timeframe: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part