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NCT Number: NCT06596915

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Part A: Advanced malignant solid tumors;
  • 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

  • 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.
  • 2. 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.

Treatment and study plan

BA1302

Drug

BA1302 administered intravenously

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

Study contacts

Contact information is provided by the study sponsor or research team.

primary investigator

CONTACT

[email protected]

13911233048

Sponsors and collaborators

Lead sponsor

Shandong Boan Biotechnology Co., Ltd

Industry

Registry information

Official study title

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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