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RecruitingNCT06596915Updated Jun 6, 2025

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of BA1302 in Non-Small Cell Lung Cancer, Pancreatic Adenocarcinoma and Breast Cancer, sponsored by Shandong Boan Biotechnology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Shandong Boan Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years later.
Phase
Phase 1
Study type
Interventional
Enrollment
167
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).

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Conditions studied

  • Non-Small Cell Lung Cancer
  • Pancreatic Adenocarcinoma
  • Breast Cancer
  • Melanoma

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 167 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

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Lead sponsor

Shandong Boan Biotechnology Co., Ltd is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.

      1. Part A: Advanced malignant solid tumors;
      2. Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell lung cancer (NSCLC), Advanced pancreatic adenocarcinoma.
  • 2.Participants should be able to provide adequate tumor tissue for biomarker analysis
  • 3.ECOG Performance Status ≤ 1.
  • 4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Exclusion criteria

Exclusion Criteria:

    1. Malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. Except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type.
    1. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days prior to the first dose.
  • 3.History of severe hypersensitivity reactions to any ingredient of study drugs.
  • 4.Pregnant or lactating women.
  • 5.Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
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Study design

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

Study arms

  • Experimental
    BA1302

    Drug: BA1302

Interventions

  • DrugBA1302

    BA1302 administered intravenously

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What researchers measure

Primary outcomes

  1. Number of participants with dose limiting toxicities

    Time frame: Up to 21 days

  2. adverse events

    Time frame: Through 28 days after the last study treatment

Secondary outcomes

  1. Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)

    Time frame: Up to approximately 1 years

  2. AUC from time zero to infinity (AUC0-inf)

    Time frame: Up to approximately 1 years

  3. Maximum serum concentration (Cmax)

    Time frame: Up to approximately 1 years

  4. Elimination half-life (t1/2)

    Time frame: Up to approximately 1 years

  5. Area under the concentration-time curve (AUC) at steady state

    Time frame: Up to approximately 1 years

  6. Incidence of anti-drug antibodies (ADA)

    Time frame: Up to approximately 1 years

  7. Objective response rate (ORR)

    Time frame: Up to approximately 1 years

  8. Duration of objective response (DOR)

    Time frame: Up to approximately 1 years

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Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06596915
Lead sponsor
Shandong Boan Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Sep 11, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jun 6, 2025

Study contacts

primary investigator
Contact
Guoj307@126.com
13911233048

Oversight

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

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