sEphB4-HSA

The combination of sEphB4-HSA and pembrolizumab has a favorable toxicity profile and favorable activity particularly among HPV-negative EphrinB2 positive patients with HNSCC.

P2/3, N=700, Not yet recruiting, Vasgene Therapeutics, Inc

P2, N=42, Active, not recruiting, University of Southern California | Phase classification: P2a --> P2 | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2025

P2, N=170, Recruiting, University of Southern California | Trial completion date: Nov 2024 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Nov 2025

P2, N=0, Withdrawn, University of Southern California | N=36 --> 0 | Not yet recruiting --> Withdrawn

P2, N=36, Not yet recruiting, University of Southern California | Trial completion date: Apr 2025 --> Aug 2025 | Trial primary completion date: Apr 2024 --> Aug 2024

P1, N=3, Completed, University of Colorado, Denver | Active, not recruiting --> Completed

P2a, N=42, Active, not recruiting, University of Southern California | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2023 --> Mar 2024

P2, N=65, Recruiting, Vasgene Therapeutics, Inc | Trial completion date: Jun 2022 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Dec 2024

In patients with mCRPC who progressed on prior second generation AR-targeted therapy, sEphB4-HSA monotherapy had no discernable anti-tumor activity.

P2, N=102, Terminated, University of Southern California | Active, not recruiting --> Terminated; Lack of funding

The combination of sEphB4-HSA and pembrolizumab appears synergistic with improved OS and ORR compared with historical data for programmed death 1/programmed death ligand 1 monotherapy.

P2, N=20, Recruiting, AIDS Malignancy Consortium | Trial completion date: Nov 2022 --> Apr 2024 | Trial primary completion date: Nov 2022 --> Mar 2024

P1, N=3, Active, not recruiting, University of Colorado, Denver | Trial primary completion date: Dec 2021 --> May 2021

P1, N=3, Terminated, University of Southern California | N=44 --> 3 | Recruiting --> Terminated; Study drug supply issue

P2a, N=42, Active, not recruiting, University of Southern California | Recruiting --> Active, not recruiting | Trial completion date: Mar 2022 --> Mar 2024 | Trial primary completion date: Mar 2021 --> Mar 2023

P1, N=3, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting | N=30 --> 3 | Trial completion date: Sep 2021 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Dec 2021

P2, N=102, Active, not recruiting, University of Southern California | Trial completion date: Sep 2021 --> Sep 2023 | Trial primary completion date: Sep 2020 --> Sep 2022

P2, N=20, Recruiting, AIDS Malignancy Consortium | Trial completion date: Nov 2020 --> Nov 2022 | Trial primary completion date: Nov 2020 --> Nov 2022

Treatment consisted of sEphB4-HSA 15 mg/kg IV every 2 weeks in combination with the FDA-approved HMA most recently or currently being used for treatment (decitabine 20mg/m2 IV/1hr on days 1 to 5 every 28 days or azacitidine 75mg/m2 SC or IV on days 1 to 7 every 28 days). This pilot study found sEphB4 in combination with HMAs to be tolerable with no significant toxicity beyond that expected with HMA therapy and associated with potential clinical benefit in MDS patients. Improvement in abnormal bone marrow MVD may indicate a potential for sEphB4-HSA plus HMA therapy to alter the malignant microenvironment in MDS/AML.

P2, N=20, Recruiting, AIDS Malignancy Consortium | N=42 --> 20

P2, N=38, Recruiting, Vasgene Therapeutics, Inc | Not yet recruiting --> Recruiting

P2, N=38, Not yet recruiting, Vasgene Therapeutics, Inc

P2, N=42, Recruiting, AIDS Malignancy Consortium | Active, not recruiting --> Recruiting

P2, N=42, Active, not recruiting, AIDS Malignancy Consortium | Recruiting --> Active, not recruiting

Pts with PC received gemcitabine 1,000 mg/m2 + nab-paclitaxel 125 mg/m2 on Days 1, 8, 15 of a 28-day cycle. Pts with BC received gemcitabine 1,000 mg/m2 + cisplatin 25 mg/m2 on Days 1, 8 of a 21-day cycle... sEphB4-HSA has a manageable safety profile in combination with chemotherapy in pts with PC and BC. Clinical activity is manifested by a high disease control rate in both cohorts and a promising RR in PC. Additional biomarker analyses will be presented.

P1, N=30, Recruiting, University of Colorado, Denver | Not yet recruiting --> Recruiting

Eligibility criteria include mCRPC with disease progression after second generation AR targeted therapy (i.e., abiraterone or enzalutamide), ECOG PS ≤ 2, and adequate renal, hepatic and hematological functions. Clinical trial information: NCT04033432. Research Funding: U.S. National Institutes of Health, Pharmaceutical/Biotech Company.

Eligibility criteria include mCRPC with disease progression after second generation AR targeted therapy (i.e., abiraterone or enzalutamide), ECOG PS ≤ 2, and adequate renal, hepatic and hematological functions. Clinical trial information: NCT04033432. Research Funding: U.S. National Institutes of Health, Pharmaceutical/Biotech Company.