A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors

Last updated: November 6, 2024
Sponsor: Shandong Boan Biotechnology Co., Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Neoplasms

Treatment

BA1106

Clinical Study ID

NCT05650242
BA1106/CT-CHN-101
  • Ages 18-75
  • All Genders

Study Summary

This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide written informed consent and to comply with the studyprotocol;

  2. Subject with histologically or cytologically confirmed advanced and/or metastaticsolid tumors who have progressed on all standard therapies, are intolerant toStandard-Of-Care (SOC), and/or are non-amenable to SOC;

  3. At least one evaluable lesion in Part A and at least one measurable lesion in Part Baccording to RECIST v1.1;

  4. Able to provide the most recent archival tumor tissue samples (negotiable);

  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: Agreement to remain abstinent (refrain fromheterosexual intercourse) or use highly effective contraceptive methods;

  9. Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or usehighly effective contraceptive methods and refrain from donating sperm.

Exclusion

Exclusion Criteria:

  1. Participants with active central nervous system (CNS) metastases causing clinicalsymptoms or metastases that require therapeutic intervention;

  2. Participants with any infection requiring intravenous therapy, or any otheruncontrolled active infection, within 2 weeks prior to informed consent;

  3. Participants with symptomatic radiation pneumonia, radiation esophagitis, radiationcolitis; extensive interstitial lung disease of both lungs, chronic obstructivepulmonary disease requiring bronchodilators or regular hormonal therapy; unhealedpeptic ulcers, cirrhosis and related complications, chronic enteritis, necrotizingenteritis, gastrointestinal obstruction (except those who are relieved withtreatment and have no safety risk as assessed by the investigator), gastrointestinalbleeding tendency or high risk of perforation, pancreatitis requiring treatment;arteriovenous thrombotic disease; chronic nephritis and nephrotic syndrome, within 8weeks prior to C1D1;

  4. Participants with active autoimmune disease or the risk of recurrence;

  5. Participants with major cardiocerebral vascular disease;

  6. Participants with body cavity effusion requiring local treatment or determined aspoorly controlled by the investigator;

  7. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DIHS (drug-induced hypersensitivity syndrome);

  8. Participants with diseases affecting intravenous injection and venous bloodcollection;

  9. Prior use of any anti-cancer therapy (including chemotherapy, radiotherapy, targetedtherapy, immunotherapy, traditional Chinese medicine, etc.) within 4 weeks, ornon-antitumor traditional Chinese medicine within 2 weeks, prior to C1D1;

  10. Prior use of drugs targeting IL-2 receptors;

  11. History of being receipt of any organ transplantation or allogeneic stem-celltransplantation;

  12. Risk of gastrointestinal ulcers or bleeding as assessed by the investigator;

  13. Prior treatment with systemic immunosuppression excluding nasal/inhaledcorticosteroids or physiological dosed systemic corticosteroids, within 2 weeksprior to C1D1;

  14. Prior treatment with cytokine, blood transfusion, or blood products within 4 weeksprior to C1D1;

  15. Participants with major surgical procedure or significant traumatic injury, within 4weeks prior to C1D1; or with wound healing complications before enrolment;

  16. Vaccination with live vaccines within 4 weeks prior to informed consent;

  17. Known hypersensitivity to any of the components of BA1106;

  18. Participants with grade 2 or higher toxicities from any previous therapies [exceptfor cases of alopecia and peripheral sensory neuropathy (both grade 2), which areallowed];

  19. Positive for Hepatitis B and C, or positive HIV test at screening;

  20. History of drug abuse, drug addiction, or alcoholism;

  21. Pregnancy, lactation, or breastfeeding;

  22. Evidence of significant, uncontrolled concomitant diseases that could affectcompliance with the protocol or interpretation of results.

Study Design

Total Participants: 177
Treatment Group(s): 1
Primary Treatment: BA1106
Phase: 1
Study Start date:
January 31, 2023
Estimated Completion Date:
December 31, 2025

Study Description

BA1106 is a human anti-CD25 monoclonal antibody. There are two parts in the study. Part A is dose escalation study, and Part B is dose expansion study. Part A will be conducted using BOIN dose escalation method at the dosing regimen of once every 3 weeks. In Part B, 12 dose levels, dosing regimens (i.e. once every 2 weeks or once every 3 weeks), and 14 selected indications will be chosen to further evaluate the safety and efficacy of BA1106.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 10036
    China

    Active - Recruiting

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