Advanced or Metastatic Solid TumorsPhase 1NCT06234397
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
A Phase 1 study testing BH3120 and pembrolizumab in people with Advanced or Metastatic Solid Tumors, run by Hanmi Pharmaceutical Company Limited at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- BH3120 and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 28 Dec 2023to Jan 2028
- 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 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.
Who cannot join
- 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 prior immunotherapy, except for adequately controlled endocrine-related adverse events managed with hormone replacement therapy.
- 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.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States5 sites, 4 recruiting
- Recruiting
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
- Withdrawn
Mary Crowley Cancer Research
Dallas, Texas, 75230
- Recruiting
The START Center for Cancer Care - Midwest
Grand Rapids, Michigan, 49546
- Recruiting
Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
San Antonio, Texas, 78229
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
South Korea5 sites, 5 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
About this study
Official title: A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors
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.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- BH3120, pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH3120Drug
BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
pembrolizumabDrug
Also called KEYTRUDA®
Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| BH3120 | Experimental | Arm A: BH3120 Monotherapy Receives: Drug: BH3120 |
| BH3120 + pembrolizumab | Experimental | Arm B: BH3120 in combination with pembrolizumab Receives: Drug: BH3120; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
Measured: Throughout the study until end of safety follow-up period (90 days after the last treatment)
Incidence and nature of DLTs
To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
Measured: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
Secondary outcomes (13)
The maximum serum concentration (Cmax)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
The time to reach Cmax (Tmax)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC during the dosing interval (AUCtau)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC extrapolated to infinity (AUCinf)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
The terminal half-life (T1/2)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent clearance (CL/F)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent volume of distribution (Vd/F)
To evaluate PK profile upon BH3120 administration
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
Frequency of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Immunogenicity of BH3120
Measured: Throughout the study until treatment discontinuation (up to 2-3 years)
Objective response rate (ORR)
ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Disease Control Rate (DCR)
DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1
Measured: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Duration of response (DOR)
DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v. 1.1 or death from any cause, whichever occurs first.
Measured: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Progression-free survival (PFS)
PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v.1.1 or until death from any cause, whichever occurs first
Measured: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start28 Dec 2023
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234397
- Sponsor's protocol ID
- BH-BAFP-101
- Other IDs
- KEYNOTE-F89, MK3475-F89
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06234397
- Acronym / sponsor ID
- BH-BAFP-101
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 31 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BH3120 | Experimental | Drug: BH3120Arm A: BH3120 Monotherapy |
| BH3120 + pembrolizumab | Experimental | Drug: BH3120, Drug: pembrolizumabArm B: BH3120 in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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 prior immunotherapy, except for adequately controlled endocrine-related adverse events managed with hormone replacement therapy.
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 |
|---|---|---|
| BH3120BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle | Drug | BH3120, BH3120 + pembrolizumab |
| pembrolizumabAlso: KEYTRUDA®Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle | Drug | BH3120 + pembrolizumab |
Primary outcome
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Time frame: Throughout the study until end of safety follow-up period (90 days after the last treatment)
To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
Incidence and nature of DLTs
Time frame: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
13 secondary outcomes
The maximum serum concentration (Cmax)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The time to reach Cmax (Tmax)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC during the dosing interval (AUCtau)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC extrapolated to infinity (AUCinf)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The terminal half-life (T1/2)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent clearance (CL/F)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent volume of distribution (Vd/F)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
Frequency of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
Objective response rate (ORR)
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Disease Control Rate (DCR)
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Duration of response (DOR)
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Progression-free survival (PFS)
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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 25 Sep 2026.
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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.
10 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 BH3120 and pembrolizumab in people with Advanced or Metastatic Solid Tumors, run by Hanmi Pharmaceutical Company Limited at 10 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 6 inclusion and 7 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, South Korea. 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 Hyunmin (Dan) Lee (82-2-410-0470, Hyunmin.lee0607@hanmi.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0. (time frame: Throughout the study until end of safety follow-up period (90 days after the last treatment)). The study lists 2 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 25 Sep 2026.