NCT07876609 A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1203 in Advanced Solid Tumors.
| NCT ID | NCT07876609 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shandong Boan Biotechnology Co., Ltd |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-10-30 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2026-10-30 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide written informed consent and to comply with the study protocol; 2. 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; 3. At least one measurable lesion according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1); 4. 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.; 5. Life expectancy \>=12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Adequate major organ function; 8. 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; 9. Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm. Exclusion Criteria: 1. Patients with primary central nervous system tumors or new or symptomatic central nervous system metastases. 2. Patients with a known history of another malignancy within 5 years prior to signing the informed consent. 3. Patients with significant cardiovascular and cerebrovascular diseases. 4. 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. 5. Any active autoimmune disease, or autoimmune or inflammatory disease requiring immunosuppressive therapy. 6. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced hypersensitivity syndrome (DIHS). 7. History of allogeneic hematopoietic stem cell transplantation or organ transplantation, or currently awaiting transplantation. 8. Immune-related adverse events during prior antitumor therapy that make the patient no longer suitable for continued immunotherapy. 9. Prior treatment with Programmed Cell Death Protein 1 / Interleukin-2 or Programmed Cell Death Protein 1 / Interleukin-15 agents.
Frequently Asked Questions
Who can join the NCT07876609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07876609 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07876609 currently recruiting?
Yes, NCT07876609 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shandong Boan Biotechnology Co., Ltd to inquire about joining.
Where is the NCT07876609 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07876609 clinical trial?
NCT07876609 is sponsored by Shandong Boan Biotechnology Co., Ltd. The trial plans to enroll 120 participants.