ClinicalTrials.gg
RecruitingNCT07876609Updated Oct 19, 2026

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1203 in Advanced Solid Tumors.

A Phase 1 interventional study of BA1203 in Solid Tumors, sponsored by Shandong Boan Biotechnology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Shandong Boan Biotechnology Co., Ltd (part of Luye Pharma Group Ltd.) · Phase 1, Interventional, and Treatment

Updated Oct 19, 2026Eligibility revisedPrimary outcomes revised+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumors
03

In context

Lead sponsor

Shandong Boan Biotechnology Co., Ltd is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

First submitted after Shandong Boan Biotechnology Co., Ltd became part of Luye Pharma Group Ltd..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    BA1203

    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.

    Drug: BA1203

Interventions

  • DrugBA1203

    intravenous (IV) once every 2 weeks (Q2W).

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Recommended phase 2 dose of BA1203

    Time frame: Through 28 days after the last study treatment

07

Study locations

1 of 1 sites recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Also revised
eligibility and primary outcomes
Registered
First appeared on the registry
Oct 15, 2026
Show all 2 updates
  1. Oct 19, 2026
    Eligibility Criteria revised
    Primary outcomes Revised (6 changes)
  2. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876609
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Oct 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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