Drugs / GI-101A
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04977453 | Aug 2021 → Jun 2028 expected | cervical cancer, clear cell renal carcinoma, metastatic neoplasm, non-small cell squamous lung carcinoma +1 | GI Innovation, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-05-22 | GI Innovation, Inc. | Results [보도자료]지아이이노베이션 GI-101A, ASCO 구두 발표 초록 공개 …"모든 표준 치료 실패 신장암서 ORR 40%" gi-innovation.com ↗
유효 용량으로 평가된 0.2~0.3 mg/kg 에서 GI-101A 단독요법은 기존 면역항암제 (IO) 불응 방광암 환자에서 완전관해 (CR) 를 유도했다 . |
| 2024-07-15 | GI Innovation, Inc. | Results [보도자료]지아이이노베이션, 면역항암제 GI-101A와 키트루다 병용서 췌장암, 신장암, 방광암 부분관해 입증 gi-innovation.com ↗ |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-26 | GI Innovation, Inc. | [보도자료]지아이이노베이션 ‘GI-101A’ 전이성 요로상피암 美 FDA 패스트트랙 지정 gi-innovation.com ↗ |
| 2026-05-22 | GI Innovation, Inc. | [보도자료]지아이이노베이션 GI-101A, ASCO 구두 발표 초록 공개 …"모든 표준 치료 실패 신장암서 ORR 40%" gi-innovation.com ↗ |
| 2026-04-03 | GI Innovation, Inc. | [보도자료]지아이이노베이션, ASCO서 GI-101A 임상 1상 구두 발표 채택 gi-innovation.com ↗ |
| 2024-07-15 | GI Innovation, Inc. | [보도자료]지아이이노베이션, 면역항암제 GI-101A와 키트루다 병용서 췌장암, 신장암, 방광암 부분관해 입증 gi-innovation.com ↗ |
| 2024-07-03 | GI Innovation, Inc. | [보도자료]지아이이노베이션, 면역항암제 GI-101A/GI-102 中 물질특허 등록 gi-innovation.com ↗ |
| 2024-03-14 | GI Innovation, Inc. | [보도자료]지아이이노베이션, 면역항암제 GI-101A/102 유럽 물질특허 등록 gi-innovation.com ↗ |
| 2024-01-29 | GI Innovation, Inc. | [보도자료]지아이이노베이션-프로젠-에스엘백시젠, 전이성 전립선암 대상 병용임상 추진…면역항암제’GI-101A’〮DNA 백신’PG-101’ gi-innovation.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GI-101A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04977453 ↗ |
| Modality | Protein / enzyme biologic | “GI-101/GI-101A is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin (IL)-2 variant as a C-terminal moiety...” NCT04977453 ↗ |
| Route | Intravenous | “administered via IV infusion” NCT04977453 ↗ |