Solid TumorPhase 1/2NCT05174585
JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
A Phase 1/2 study testing JAB-BX102 (anti-CD73 monoclonal antibody) and pembrolizumab (anti-PD-1 monoclonal antibody) in people with Solid Tumor, run by Jacobio Pharmaceuticals Co., Ltd. at 6 sites in China.
Trial summary
This study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- JAB-BX102 (anti-CD73 monoclonal antibody) and pembrolizumab (anti-PD-1 monoclonal antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 6 sitesChina
- Study dates
- 18 Aug 2022to 9 May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Must be able to provide an archived tumor sample
- Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
- Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition, or patient has no access to SOC treatment.
- Must have at least 1 measurable lesion per RECIST v1.1
- Must have adequate organ functions
Who cannot join
- Has central nervous system(CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
- Active infection requiring systemic treatment within 7 days
- Active hepatitis C virus(HBV), hepatitis C virus(HCV), or HIV
- Any severe and/or uncontrolled medical conditions
- Left ventricular ejection fraction(LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
- QTcF(Corrected QT interval - Fredericia formula) interval >470 msec
- Experiencing unresolved CTCAE 5.0 Grade >1 toxicities
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Hunan Cancer Hospital
Changsha, Hunan, 410013
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
This study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of JAB-BX102 monotherapy to determine the MTD(maximum tolerated dose) and RP2D(Recommended Phase 2 Dose) during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-BX102 is administered in combination with pembrolizumab during Dose Expansion phase in patients with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- JAB-BX102 (anti-CD73 monoclonal antibody), pembrolizumab (anti-PD-1 monoclonal antibody)
- Keywords
- Solid Tumor, Anti-CD73 Monoclonal Antibody, CD73
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-BX102 (anti-CD73 monoclonal antibody)Biological
Administered by intravenous infusion (IV)
pembrolizumab (anti-PD-1 monoclonal antibody)Biological
Also called KEYTRUDA®
Administered by intravenous infusion (IV)
| Study group | Role | What they receive |
|---|---|---|
| Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation | Experimental | Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D. Receives: Biological: JAB-BX102 (anti-CD73 monoclonal antibody) |
| Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion | Experimental | JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity. Receives: Biological: JAB-BX102 (anti-CD73 monoclonal antibody); Biological: pembrolizumab (anti-PD-1 monoclonal antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
A DLT is defined as the clinically significant TRAE(treatment-related adverse events) or abnormal laboratory values assessment during the first 21 days of Cycle 1 and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.
Measured: First 21 days of Cycle 1
Dose Escalation and Dose Expansion phase: Number of participants with adverse events
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE 5.0.
Measured: Up to 3 years
Dose Expansion phase: Overall response rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.
Measured: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Expansion phase: Duration of response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Measured: Up to 3 years
Secondary outcomes (5)
To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab
observed plasma concentration of JAB-BX102
Measured: Up to 3 years
Dose Escalation phase: Overall response rate (ORR)
The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
Measured: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Dose Escalation phase: Duration of response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per CTCAE v1.1.
Measured: Up to 3 years
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start18 Aug 2022
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174585
- Sponsor's protocol ID
- JAB-BX102-1001
- Other IDs
- MK-3475-E58, KEYNOTE-E58
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2021
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05174585
- Acronym / sponsor ID
- JAB-BX102-1001
- Conditions
- Solid Tumor
- Keywords
- Solid Tumor, Anti-CD73 Monoclonal Antibody, CD73
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 3 Jan 2022 (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 study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of JAB-BX102 monotherapy to determine the MTD(maximum tolerated dose) and RP2D(Recommended Phase 2 Dose) during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-BX102 is administered in combination with pembrolizumab during Dose Expansion phase in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation | Experimental | Biological: JAB-BX102 (anti-CD73 monoclonal antibody)Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D. |
| Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion | Experimental | Biological: JAB-BX102 (anti-CD73 monoclonal antibody), Biological: pembrolizumab (anti-PD-1 monoclonal antibody)JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be able to provide an archived tumor sample
- Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor
- Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition, or patient has no access to SOC treatment.
- Must have at least 1 measurable lesion per RECIST v1.1
- Must have adequate organ functions
Key exclusion criteria (7 listed)
- Has central nervous system(CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days
- Active infection requiring systemic treatment within 7 days
- Active hepatitis C virus(HBV), hepatitis C virus(HCV), or HIV
- Any severe and/or uncontrolled medical conditions
- Left ventricular ejection fraction(LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
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 |
|---|---|---|
| JAB-BX102 (anti-CD73 monoclonal antibody)Administered by intravenous infusion (IV) | Biological | Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation, Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion |
| pembrolizumab (anti-PD-1 monoclonal antibody)Also: KEYTRUDA®Administered by intravenous infusion (IV) | Biological | Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion |
Primary outcome
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
Time frame: First 21 days of Cycle 1
A DLT is defined as the clinically significant TRAE(treatment-related adverse events) or abnormal laboratory values assessment during the first 21 days of Cycle 1 and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.
Dose Escalation and Dose Expansion phase: Number of participants with adverse events
Time frame: Up to 3 years
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE 5.0.
Dose Expansion phase: Overall response rate (ORR)
Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.
Expansion phase: Duration of response (DOR)
Time frame: Up to 3 years
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
5 secondary outcomes
To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab
Time frame: Up to 3 years
Dose Escalation phase: Overall response rate (ORR)
Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Dose Escalation phase: Duration of response (DOR)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
Time frame: Up to 3 years
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JAB-BX102 (anti-CD73 monoclonal antibody) and pembrolizumab (anti-PD-1 monoclonal antibody) in people with Solid Tumor, run by Jacobio Pharmaceuticals Co., Ltd. at 6 sites in China.
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 5 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) (time frame: First 21 days of Cycle 1). The study lists 4 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 6 Jan 2026.