Solid TumorsPhase 1NCT05650242
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors
A Phase 1 study testing BA1106 in people with Solid Tumors, run by Shandong Boan Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BA1106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2023to Dec 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent and to comply with the study protocol;
- Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC;
- At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1;
- Able to provide the most recent archival tumor tissue samples (negotiable);
- Life expectancy >=12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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- Adequate major organ function;
- Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods;
- Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.
Who cannot join
- Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention;
- Participants with any infection requiring intravenous therapy, or any other uncontrolled active infection, within 2 weeks prior to informed consent;
- Participants with symptomatic radiation pneumonia, radiation esophagitis, radiation colitis; extensive interstitial lung disease of both lungs, chronic obstructive pulmonary disease requiring bronchodilators or regular hormonal therapy; unhealed peptic ulcers, cirrhosis and related complications, chronic enteritis, necrotizing enteritis, gastrointestinal obstruction (except those who are relieved with treatment and have no safety risk as assessed by the investigator), gastrointestinal bleeding tendency or high risk of perforation, pancreatitis requiring treatment; arteriovenous thrombotic disease; chronic nephritis and nephrotic syndrome, within 8 weeks prior to C1D1;
- Participants with active autoimmune disease or the risk of recurrence;
- Participants with major cardiocerebral vascular disease;
- Participants with body cavity effusion requiring local treatment or determined as poorly controlled by the investigator;
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- History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DIHS (drug-induced hypersensitivity syndrome);
- Participants with diseases affecting intravenous injection and venous blood collection;
- Prior use of any anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, traditional Chinese medicine, etc.) within 4 weeks, or non-antitumor traditional Chinese medicine within 2 weeks, prior to C1D1;
- Prior use of drugs targeting IL-2 receptors;
- History of being receipt of any organ transplantation or allogeneic stem-cell transplantation;
- Risk of gastrointestinal ulcers or bleeding as assessed by the investigator;
- Prior treatment with systemic immunosuppression excluding nasal/inhaled corticosteroids or physiological dosed systemic corticosteroids, within 2 weeks prior to C1D1;
- Prior treatment with cytokine, blood transfusion, or blood products within 4 weeks prior to C1D1;
- Participants with major surgical procedure or significant traumatic injury, within 4 weeks prior to C1D1; or with wound healing complications before enrolment;
- Vaccination with live vaccines within 4 weeks prior to informed consent;
- Known hypersensitivity to any of the components of BA1106;
- Participants with grade 2 or higher toxicities from any previous therapies [except for cases of alopecia and peripheral sensory neuropathy (both grade 2), which are allowed];
- Positive for Hepatitis B and C, or positive HIV test at screening;
- History of drug abuse, drug addiction, or alcoholism;
- Pregnancy, lactation, or breastfeeding;
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 10036
Lin Shen, 13911219511, doctorshenlin@sina.com
About this study
Official title: An Non-randomized Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy of BA1106 in Participants With Advanced Solid Tumors
This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors.
Read the detailed description
BA1106 is a human anti-CD25 monoclonal antibody. There are two parts in the study. Part A is dose escalation study, and Part B is dose expansion study. Part A will be conducted using BOIN dose escalation method at the dosing regimen of once every 3 weeks. In Part B, 1~2 dose levels, dosing regimens (i.e. once every 2 weeks or once every 3 weeks), and 1~4 selected indications will be chosen to further evaluate the safety and efficacy of BA1106.
- Conditions
- Solid Tumors
- Being tested
- BA1106
- Keywords
- BA1106, First in human study, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA1106Drug
In part A, after the observation period of DLT (28 days), intravenous (IV) once every 3 weeks (Q3W).
In Part B, intravenous (IV) once every 3 weeks (Q3W) or once every 2 weeks (Q2W).
| Study group | Role | What they receive |
|---|---|---|
| BA1106 | Experimental | Part A (Dose-Escalation): Mixed solid tumors participants will receive ascending doses of BA1106. BA1106 will be administered by intravenous (IV) infusion. The observation period of Dose Limiting toxicity (DLT) is 28 days, then the participants will receive BA1106 every three weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years.
Part B (Dose-Expansion): Participants of selected tumors will receive a fixed dose of BA1106 that selected according to the results of Part A once every 3 weeks (Q3W) or once every 2 weeks (Q2W), until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years. Receives: Drug: BA1106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Measured: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
Secondary outcomes (14)
Area under the curve (AUC) of BA1106
Measured: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Half-life (t1/2) of BA1106
Measured: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Maximum Concentration (Cmax) of BA1106
Measured: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Minimum Concentration (Cmin) of BA1106
Measured: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Time of maximum concentration (Tmax) of BA1106
Measured: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Clearance (CL) of BA1106
Measured: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Volume of distribution at steady-state conditions (Vss) of BA1106
Measured: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Incidence and titer of Anti-Drug Antibodies (ADA) during the study relative to the prevalence of ADA at baseline
Measured: up to 2 years
Incidence of Neutralizing Antibodies (Nab) during the study relative to the prevalence of Nab at baseline
Measured: up to 2 years
Objective Response Rate (ORR)
Measured: up to 2 years
Duration of Response (DOR)
Measured: up to 2 years
Disease Control Rate (DCR)
Measured: up to 2 years
Progression-Free Survival (PFS)
Measured: up to 2 years
Overall Survival (OS)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start31 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Boan Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650242
- Sponsor's protocol ID
- BA1106/CT-CHN-101
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Non-randomized Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy of BA1106 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05650242
- Acronym / sponsor ID
- BA1106/CT-CHN-101
- Conditions
- Solid Tumors
- Keywords
- BA1106, First in human study, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Shandong Boan Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Dec 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 is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors.
Detailed description
BA1106 is a human anti-CD25 monoclonal antibody. There are two parts in the study. Part A is dose escalation study, and Part B is dose expansion study. Part A will be conducted using BOIN dose escalation method at the dosing regimen of once every 3 weeks. In Part B, 1~2 dose levels, dosing regimens (i.e. once every 2 weeks or once every 3 weeks), and 1~4 selected indications will be chosen to further evaluate the safety and efficacy of BA1106.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BA1106 | Experimental | Drug: BA1106Part A (Dose-Escalation): Mixed solid tumors participants will receive ascending doses of BA1106. BA1106 will be administered by intravenous (IV) infusion. The observation period of Dose Limiting toxicity (DLT) is 28 days, then the participants will receive BA1106 every three weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years. Part B (Dose-Expansion): Participants of selected tumors will receive a fixed dose of BA1106 that selected according to the results of Part A once every 3 weeks (Q3W) or once every 2 weeks (Q2W), until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able and willing to provide written informed consent and to comply with the study protocol;
- Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC;
- At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1;
- Able to provide the most recent archival tumor tissue samples (negotiable);
- Life expectancy >=12 weeks;
Key exclusion criteria (22 listed)
- Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention;
- Participants with any infection requiring intravenous therapy, or any other uncontrolled active infection, within 2 weeks prior to informed consent;
- Participants with symptomatic radiation pneumonia, radiation esophagitis, radiation colitis; extensive interstitial lung disease of both lungs, chronic obstructive pulmonary disease requiring bronchodilators or regular hormonal therapy; unhealed peptic ulcers, cirrhosis and related complications, chronic enteritis, necrotizing enteritis, gastrointestinal obstruction (except those who are relieved with treatment and have no safety risk as assessed by the investigator), gastrointestinal bleeding tendency or high risk of perforation, pancreatitis requiring treatment; arteriovenous thrombotic disease; chronic nephritis and nephrotic syndrome, within 8 weeks prior to C1D1;
- Participants with active autoimmune disease or the risk of recurrence;
- Participants with major cardiocerebral vascular disease;
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 |
|---|---|---|
| BA1106In part A, after the observation period of DLT (28 days), intravenous (IV) once every 3 weeks (Q3W). In Part B, intravenous (IV) once every 3 weeks (Q3W) or once every 2 weeks (Q2W). | Drug | BA1106 |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
14 secondary outcomes
Area under the curve (AUC) of BA1106
Time frame: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Half-life (t1/2) of BA1106
Time frame: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Maximum Concentration (Cmax) of BA1106
Time frame: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Minimum Concentration (Cmin) of BA1106
Time frame: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Time of maximum concentration (Tmax) of BA1106
Time frame: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Clearance (CL) of BA1106
Time frame: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Volume of distribution at steady-state conditions (Vss) of BA1106
Time frame: up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)
Incidence and titer of Anti-Drug Antibodies (ADA) during the study relative to the prevalence of ADA at baseline
Time frame: up to 2 years
Incidence of Neutralizing Antibodies (Nab) during the study relative to the prevalence of Nab at baseline
Time frame: up to 2 years
Objective Response Rate (ORR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BA1106 in people with Solid Tumors, run by Shandong Boan Biotechnology Co., Ltd at 1 site 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 9 inclusion and 22 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 Lin Shen (13911219511, doctorshenlin@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0). (time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.). 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 13 Oct 2026.