Drugs / CTX-009
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07392957 | Jun 2026 → Jun 2029 expected | glioblastoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06548412 | Jan 2025 → May 2027 expected | biliary tract cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04492033 | Jun 2020 → Jan 2024 | biliary tract cancer, cancer of unknown primary site | Handok Inc. | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05513742 | Dec 2022 → May 2025 | colon carcinoma, rectal carcinoma | Compass Therapeutics | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05506943 | Jan 2023 → Aug 2027 expected | ampulla of vater cancer, cholangiocarcinoma, gallbladder cancer | Compass Therapeutics | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-04-28 | ABL Bio, Inc. | Results 에이비엘바이오 파트너사 컴퍼스 테라퓨틱스, 담도암 환자 대상 토베시미그(ABL001) 임상 2/3상 데이터 발표 ablbio.com ↗
컴퍼스 테라퓨틱스가 공개한 COMPANION-002 데이터에 따르면, 토베시미그와 파클리탁셀 병용요법은 PFS 중앙값 4.7개월을 기록하며, 파클리탁셀 단독요법의 PFS 중앙값 2.6개월 대비 통계적으로 유의한 개선을 나타냈다(HR=0.44, p<0.0001). |
| 2026-04-27 | Compass Therapeutics | Results Tovecimig Demonstrates Statistically Significant Benefit in COMPANION-002 Randomized Phase 2/3 Study in Patients with Biliary Tract Cancer compasstherapeutics.com ↗
Secondary endpoint analyses of overall survival (OS) were confounded by both high crossover (54%) and notably prolonged survival in crossover patients randomized to the control arm then treated with tovecimig and, therefore, did not meet statistical significance. |
| 2026-04-08 | ABL Bio, Inc. | Regulatory 에이비엘바이오 파트너사 컴퍼스 테라퓨틱스, 담도암 치료제 토베시믹(ABL001) FDA 희귀의약품 지정 ablbio.com ↗
이중항체 전문기업 에이비엘바이오(대표 이상훈)는 자사의 글로벌 파트너사 컴퍼스 테라퓨틱스(Compass Therapeutics)가 개발 중인 담도암 치료제 토베시믹(Tovecimig/CTX-009/ABL001)이 미국 식품의약국(FDA)으로부터 희귀의약품 지정(Orphan Drug Designation)을 받았다고 8일 밝혔다. |
| 2025-08-13 | ABL Bio, Inc. | Results 에이비엘바이오 파트너사 컴퍼스, ABL001 OS 개선 기대… 임상 2/3상에서 예상보다 낮은 사망률 확인 ablbio.com ↗ |
| 2025-04-29 | Elpiscience Biopharma, Ltd. | Results VEGF/DLL4 Bispecific Antibody Meets Primary Endpoint in Phase 2/3 Clinical Trial for Biliary Tract Cancer elpiscience.com ↗
The VEGF/DLL4 bispecific antibody (CTX-009/ES104) has successfully achieved its primary endpoint in a Phase 2/3 clinical trial for biliary tract cancer (BTC), showing potential as a new global standard for second-line BTC treatment. |
| 2025-04-28 | Compass Therapeutics | Results Compass Therapeutics Presents Data on Enhanced Efficacy of CTX-471 in Combination with Tovecimig in Checkpoint-Refractory Models at the American Association for Cancer Research (AACR) Annual Meeting compasstherapeutics.com ↗
Combining CTX-471 with tovecimig (CTX-009) markedly increased anti-tumor efficacy in these models. |
| 2025-04-02 | ABL Bio, Inc. | Results 에이비엘바이오 파트너사 컴퍼스 테라퓨틱스, 담도암 환자 대상 ABL001 임상 2/3상 탑라인 발표 ablbio.com ↗
컴퍼스 테라퓨틱스가 발표한 임상 2/3상 탑라인 데이터에 따르면, ABL001/토베시미그 및 파클리탁셀 병용요법의 ORR은 1건의 완전관해(Complete Response, CR) 사례를 포함해 17.1%(19/111)로, 파클리탁셀 단독요법의 ORR 5.3%(3/57)와 비교해 통계적으로 유의한 차이를 보였다(P=0.031). |
| 2025-04-01 | Compass Therapeutics | Results Tovecimig (CTX-009) Meets Primary Endpoint in the Ongoing Randomized Phase 2/3 Study in Patients with Biliary Tract Cancer compasstherapeutics.com ↗
The difference in ORR between the two treatment arms, the primary endpoint of the study, was statistically significant (p=0.031), and all responses have been confirmed by blinded independent central radiology review. |
| 2024-04-25 | Compass Therapeutics | Regulatory Compass Therapeutics Receives FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Patients with Metastatic or Locally Advanced Biliary Tract Tumors That Have Been Previously Treated compasstherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CTX-009, the Company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel for the treatment of patients with metastatic or locally advanced BTC that have been previously treated. |
| 2024-04-09 | Compass Therapeutics | Results Compass Therapeutics Presents Data Demonstrating Elimination of MHC Class I Negative Tumors in In Vivo Models at the 2024 American Association for Cancer Research (AACR) Annual Meeting compasstherapeutics.com ↗
Immune responses were generated toward the MHC-I negative tumors by combining CTX-009 with CTX-471. |
| 2023-01-19 | Compass Therapeutics | Results Compass Therapeutics Announces that the Phase 2 Data of CTX-009 in Combination with Paclitaxel in Patients with Biliary Tract Cancers (BTC) will be Presented at the ASCO GI Cancers Symposium on January 20, 2023 compasstherapeutics.com ↗
In the primary analysis of all 24 patients participating in the study, CTX-009 with paclitaxel demonstrated a 37.5% ORR based on 9 patients with Partial Responses (PRs) that were confirmed by RECIST 1.1. |
| 2022-05-06 | Elpiscience Biopharma, Ltd. | Results Positive Interim ES104 Phase 2 Data Reported in Combination with Paclitaxel in Biliary Tract Cancers elpiscience.com ↗
today announced partner Compass Therapeutics reported positive interim ES104 (also known as CTX-009) Phase 2 data in combination with paclitaxel in patients with biliary tract cancers (BTC) . |
| 2022-05-04 | Compass Therapeutics | Results Compass Therapeutics Reports Positive Interim Phase 2 Data of CTX-009 in Combination with Paclitaxel in Biliary Tract Cancers compasstherapeutics.com ↗
CTX-009 demonstrated a 42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation |
| 2022-01-20 | Compass Therapeutics | Regulatory Compass Therapeutics Announces US FDA Clearance of Investigational New Drug Application for a Phase 2 Study of CTX-009, a Bispecific Antibody That Simultaneously Targets Delta-like Ligand 4 (DLL4) and Vascular Endothelial Growth Factor A (VEGF-A) compasstherapeutics.com ↗
BOSTON , Jan. 20, 2022 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its IND application for CTX-009, enabling the company to initiate a global Phase 2 clinical trial for CTX-009 in patients who have advanced Biliary Tract Cancers (BTC) in the United States and South Korea . |
| 2021-11-01 | Compass Therapeutics | Results Compass Reports the Advancement of CTX-009, a Bispecific Antibody, to Phase 2a Development in Patients with Biliary Tract Cancers (BTC), and the Clearance of a Key Clinical Hurdle compasstherapeutics.com ↗
Enrollment in the first part of the study has been completed and the criteria to advance to the second part of the study have been met. |
| 2021-10-08 | Compass Therapeutics | Results CTX-009 (ABL001/ES104) Clinical Data Presented Today at the New Drugs on the Horizon Plenary Session of the 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics compasstherapeutics.com ↗
Treatment with CTX-009 at the RP2D (10.0 mg/kg and 12.5 mg/kg) led to 19% (n=3/16) ORR, not including an additional unconfirmed partial response, and a 69% DCR (n=11/16) |
| 2021-09-10 | Elpiscience Biopharma, Ltd. | Results ES104 (CTX-009/ABL001) Clinical Data Presented at the 2021 AACR-NCI-EORTC International Conference elpiscience.com ↗
Treatment with ES104 at the RP2D (10.0 mg/kg and 12.5 mg/kg) led to 19% (n=3/16) ORR, not including an additional unconfirmed partial response, and a 69% DCR (n=11/16); |
All press releases naming this drug 24 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CTX-009 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07392957 ↗ |
| Known as | ABL001 | “CTX-009 (ABL001) will be administered biweekly.” NCT04492033 ↗ |
| Action | Inhibit | “CTX-009 expands on existing anti-angiogenic therapies by ablating key compensatory and resistance mechanisms to bevacizumab” NCT07392957 ↗ |
| Route | Intravenous | “IV infusion on day 1 and 14 of every 28 day cycle” NCT05506943 ↗ |
| Target | DLL4 | “CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A” PMID 38861293 ↗ Jun 2024 |