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진행성 고형암 환자를 대상으로 KVA12123(TBS-2025) 단독 요법 및 pembrolizumab 병용 요법을 평가하는 임상시험

A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목 내용
등록번호 NCT05708950
상태 완료
단계 1상/2상
시험 약물/중재 KVA12123 - Dose Escalation, KVA12123 Plus Pembrolizumab - Dose Escalation, KVA12123 - Dose Expansion, KVA12123 Plus Pembrolizumab - Dose Expansion
대상 질환 Cancer, Solid Tumor, Melanoma, Carcinoma, Sarcoma, Lung Cancer
스폰서 Kineta Inc.
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 40
시작 / 1차 완료 예정 2023-03-03 / 2025-10-16
국내 실시기관 없음
실시 국가 1개국, 기관 7곳 (United States)
결과 게시 아니오
최근 갱신 2026-10-05

시험 개요

이 임상시험은 진행성 고형암(advanced solid tumors) 환자를 대상으로 신약 KVA12123(이후 TBS-2025로 명명)을 단독으로 혹은 pembrolizumab과 병용하여 투여했을 때의 안전성과 유효성을 평가했습니다. 연구는 용량 증량(dose escalation) 단계와 계획된 용량 확장(dose expansion) 단계로 구성되었으나, 고형암 분야 개발 중단이라는 사업적 결정에 따라 용량 증량 단계만 진행되고 종료되었습니다. 이 결정은 안전성 우려와는 무관합니다. 총 40명의 환자 참여가 목표였습니다.

  • 진행성 고형암 환자를 대상으로 KVA12123(TBS-2025) 단독 및 pembrolizumab 병용 투여의 안전성을 평가했습니다.
  • 연구는 용량 증량 단계와 용량 확장 단계로 계획되었으나, 사업적 결정으로 인해 용량 증량 단계만 수행되고 완료되었습니다.
  • 목표 인원은 40명이었으며, 국내 기관은 0곳입니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: 1. 동의서 제공 능력이 있는 18세 이상 성인. 2. 표준 치료에 진행하였거나 반응하지 않는 조직학적 또는 세포학적으로 확진된 국소 진행성 또는 전이성 고형암. 3. 예상 생존 기간이 16주 이상. 4. iRECIST 기준에 따른 측정 가능한 병변 존재. 5. ECOG 수행 능력 상태 점수가 0 또는 1. 제외 기준: 1. 치료되지 않은 중추신경계(CNS) 전이 질환, 수막 질환 또는 척수 압박. 2. 연구 대상 질환 외에 전신 치료가 필요한 동시성 암. 3. 과거 3년 이내에 진행되었거나 적극적인 치료가 필요했던 알려진 추가 악성 종양. 4. 면역결핍 진단을 받았거나 연구 약물 첫 투여 전 7일 이내에 만성 전신 스테로이드 요법을 받는 경우.

선정/제외 기준 원문 (영어)

Inclusion Criteria

  1. Willing and able to provide informed consent.
  2. Be at least 18 years of age at the time of consent.
  3. Has histologically or cytologically confirmed, locally advanced or metastatic solid tumor that has progressed or was non-responsive to standard of care therapy and for which no available curative therapy exists.
  4. Has expected survival ≥16 weeks.
  5. Presence of measurable disease by iRECIST.
  6. Has an ECOG performance status score of 0 or 1.
  7. Has adequate organ function within 10 days prior to the start of study treatment.
  8. Has normal thyroid function or hypothyroid with stable supplementation.
  9. Has consented to the collection of archival tissue prior to study treatment initiation.
  10. Participants with prior exposure to systemic anticancer therapy including investigational agents following a 4-week washout period are eligible. Participants with prior small molecule targeted therapy or other short half-life drugs are eligible following a 2-week washout period.
  11. Participants having prior curative radiation therapy completed 2 weeks prior to study drug administration or prior palliative radiation therapy to non-CNS disease completed at least 1 week prior to study drug administration are eligible.
  12. HIV-infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease.
  13. Participants with a history of HBV infection having durable HBsAg loss and undetectable serum HBV DNA no longer requiring treatment are eligible.
  14. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening and participants have completed curative antiviral therapy.
  15. Post-menopausal women and surgically sterile men and women are permitted.

  16. Patients of childbearing potential are permitted to participate under the following conditions:

    1. Must have negative urine pregnancy test result within 72 hrs prior to the first dose of any study drug
    2. Must agree not to become pregnant during the study and for 120 days after the final dose of any study drug
    3. Must agree not to breastfeed or donate ova, starting at time of informed consent and continuing through 120 days after the final dose of any study drug
    4. If sexually active in a way that could lead to pregnancy, must consistently use 2 acceptable methods of birth control (contraception), at least 1 of which must be highly effective starting at time of informed consent and continuing throughout the study and for 120 days after the final dose of any study drug.

  17. Patients who can father children are permitted to participate under the following conditions:

    1. Must agree not to donate sperm starting at the time of informed consent and continuing throughout the study period and for 120 days after the final dose of any study drug
    2. If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use 2 acceptable methods of birth control (contraception), at least 1 of which must be highly effective starting at the time of informed consent and continuing throughout the study and for 120 days after the final dose of any study drug
    3. If sexually active with a person who is pregnant or breastfeeding, must consistently use a condom starting at time of informed consent and continuing throughout the study and for 120 days after the final dose of any study drug.

  18. Must be willing and able to comply with the trial procedures and the follow-up schedule.

Exclusion Criteria

  1. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression.
  2. Concurrent cancer other than disease under study requiring systemic treatment. Participants with basal cell or squamous cell skin cancer treated with curative intent, carcinoma in-situ of the cervix or breast treated with curative intent, RAI stage 0 Chronic Lymphocytic Leukemia, monoclonal gammopathy of undetermined significance, superficial bladder cancer or very low and low risk prostate cancer (localized Gleason score ≤ 6) under active surveillance are eligible.
  3. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg QD of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
  5. History of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or current pneumonitis/ILD.
  6. Prior treatment with VISTA-targeted therapy.
  7. Prior history of allogeneic, solid organ or stem cell transplant, or adoptive T-cell transplant.
  8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, LAG-3, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE).
  9. Active known or suspected autoimmune disease that has required systemic treatment within the past year. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  10. Prior systemic anticancer therapy, including investigational agents, within 4 weeks of treatment. Participants with prior small molecule targeted therapy or other short half-life drugs are eligible following a 2-week washout period.
  11. Has received prior radiation therapy within 2 weeks of start of study treatment or has a history of radiation pneumonitis.
  12. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study treatment.
  13. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
  14. Any requirement for daily supplemental oxygen.
  15. Any condition requiring systemic treatment with corticosteroids (>10 mg QD prednisone equivalents) or other immunosuppressive medications within 14 days before the first dose of study drug.
  16. Serious or poorly controlled cardiovascular disease.
  17. Chronic hepatitis B or C.
  18. HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  19. Has an active infection requiring systemic therapy.
  20. Known active or latent tuberculosis.
  21. If the participant had major surgery, must have recovered adequately from the procedure and/or any complications.
  22. Toxicities arising from prior cancer therapy that have not resolved to Grade 1 or baseline.
  23. Red blood cell or platelet infusion within the preceding 2 weeks.
  24. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  25. Known hypersensitivity to any excipient contained in the drug formulation of KVA12123.
  26. Any significant history of drug allergy as assessed by the investigator.
  27. Positive urine pregnancy test within 72 hrs of study drug administration.
  28. Participants who are breastfeeding, pregnant, or planning to become pregnant from time of informed consent until at least 120 days after final dose of study drug.
  29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study.
  30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  31. Inability to comply with study procedures.

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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