Solid TumorsPhase 1NCT07876609
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1203 in Advanced Solid Tumors.
A Phase 1 study testing BA1203 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 BA1203 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?
- BA1203
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 31 Dec 2030
- 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 measurable lesion according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1);
- Patients with colorectal cancer must have a microsatellite instability (MSI) test report, and patients with other tumor types must have a prior Programmed Death-Ligand 1 (PD-L1) histopathological examination report; if unavailable, tumor tissue specimens must be provided for the above tests.;
- 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 must have a negative pregnancy test within 7 days prior to the first dose: 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
- Patients with primary central nervous system tumors or new or symptomatic central nervous system metastases.
- Patients with a known history of another malignancy within 5 years prior to signing the informed consent.
- Patients with significant cardiovascular and cerebrovascular diseases.
- Presence of any of the following within 8 weeks before the first dose: symptomatic radiation pneumonitis, radiation esophagitis, or radiation-induced colitis/proctitis; interstitial lung disease; pulmonary disease with severe obstructive ventilatory impairment; unhealed peptic ulcer; cirrhosis-related complications; chronic enteritis; ischemic necrotizing enteritis; gastrointestinal obstruction; tendency to gastrointestinal bleeding or high risk of gastrointestinal perforation; pancreatitis requiring treatment; arterial or venous thrombotic disease; chronic nephritis; or nephrotic syndrome.
- Any active autoimmune disease, or autoimmune or inflammatory disease requiring immunosuppressive therapy.
- History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced hypersensitivity syndrome (DIHS).
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- History of allogeneic hematopoietic stem cell transplantation or organ transplantation, or currently awaiting transplantation.
- Immune-related adverse events during prior antitumor therapy that make the patient no longer suitable for continued immunotherapy.
- Prior treatment with Programmed Cell Death Protein 1 / Interleukin-2 or Programmed Cell Death Protein 1 / Interleukin-15 agents.
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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Jie Wang, 8610-87788525, zlhuxi@163.com
About this study
Official title: A Multicenter, Open-Label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BA1203 Injection in Patients 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 BA1203 in participants with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- BA1203
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA1203Drug
intravenous (IV) once every 2 weeks (Q2W).
| Study group | Role | What they receive |
|---|---|---|
| BA1203 | Experimental | Participants will receive BA1203 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: BA1203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) , immune-related AEs(irAEs), infusion-related reactions (IRRs), AEs of special interest (AESIs)
Measured: Through 28 days after the last study treatment
Incidence and severity of dose limiting toxicities in each dose cohort, and maximum tolerated dose
Measured: Through 28 days after the last study treatment
Recommended phase 2 dose of BA1203
Measured: Through 28 days after the last study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (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
- 120 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
- NCT07876609
- Sponsor's protocol ID
- BA1203/CT-CHN-101
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BA1203 Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07876609
- Acronym / sponsor ID
- BA1203/CT-CHN-101
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shandong Boan Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Oct 2026 (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 BA1203 in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BA1203 | Experimental | Drug: BA1203Participants will receive BA1203 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 measurable lesion according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1);
- Patients with colorectal cancer must have a microsatellite instability (MSI) test report, and patients with other tumor types must have a prior Programmed Death-Ligand 1 (PD-L1) histopathological examination report; if unavailable, tumor tissue specimens must be provided for the above tests.;
- Life expectancy >=12 weeks;
Key exclusion criteria (9 listed)
- Patients with primary central nervous system tumors or new or symptomatic central nervous system metastases.
- Patients with a known history of another malignancy within 5 years prior to signing the informed consent.
- Patients with significant cardiovascular and cerebrovascular diseases.
- Presence of any of the following within 8 weeks before the first dose: symptomatic radiation pneumonitis, radiation esophagitis, or radiation-induced colitis/proctitis; interstitial lung disease; pulmonary disease with severe obstructive ventilatory impairment; unhealed peptic ulcer; cirrhosis-related complications; chronic enteritis; ischemic necrotizing enteritis; gastrointestinal obstruction; tendency to gastrointestinal bleeding or high risk of gastrointestinal perforation; pancreatitis requiring treatment; arterial or venous thrombotic disease; chronic nephritis; or nephrotic syndrome.
- Any active autoimmune disease, or autoimmune or inflammatory disease requiring immunosuppressive 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 |
|---|---|---|
| BA1203intravenous (IV) once every 2 weeks (Q2W). | Drug | BA1203 |
Primary outcome
Incidence and severity of adverse events (AEs) , immune-related AEs(irAEs), infusion-related reactions (IRRs), AEs of special interest (AESIs)
Time frame: Through 28 days after the last study treatment
Incidence and severity of dose limiting toxicities in each dose cohort, and maximum tolerated dose
Time frame: Through 28 days after the last study treatment
Recommended phase 2 dose of BA1203
Time frame: Through 28 days after the last study treatment
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 19 Oct 2026.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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 BA1203 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 9 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 19 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) , immune-related AEs(irAEs), infusion-related reactions (IRRs), AEs of special interest (AESIs) (time frame: Through 28 days after the last study treatment). The study lists 3 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 19 Oct 2026.