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Trials |  |
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- | D2C7 / Istari Oncology
Phase classification: D2C7-IT + 2141-V11 Combination Post-resection in rGBM (clinicaltrials.gov) - Oct 10, 2024
P1, N=46, Not yet recruiting, Sponsor: Darell Bigner
Phase classification: P1/2 --> P1
- Intratumoral Fc-engineered agonistic CD40 antibody induces tumor rejection and systemic antitumor immunity in metastatic cancer patients. A bench-to-bedside and back approach (Grand Ballroom AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1806;
P1
c-d) Scheme and results of rechallenge experiment with 2141-V11. d) Representative image and results of abscopal effect of 2141-V11
- Intratumoral Fc-engineered agonistic CD40 antibody induces tumor rejection and systemic antitumor immunity in metastatic cancer patients. A bench-to-bedside and back approach (George R. Brown Convention Center - Level 3 - Grand Ballroom C) - Oct 4, 2024 - Abstract #SITC2024SITC_1480;
P1
c-d) Scheme and results of rechallenge experiment with 2141-V11. d) Representative image and results of abscopal effect of 2141-V11
- | 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Journal, Metastases: Intratumoral Fc-optimized agonistic CD40 antibody induces tumor rejection and systemic antitumor immunity in patients with metastatic cancer. (Pubmed Central) - Jun 17, 2024
P1
In a humanized mouse model for CD40 and Fc?Rs, 2141-V11 induced TLS formation in mice bearing orthotopic breast carcinoma, correlating with local and abscopal antitumor effects, systemic immune activation, and immune memory. These findings support the safety and efficacy of 2141-V11, warranting phase 2 studies and suggesting a unique mechanism of action for this Fc-enhanced immunotherapy (NCT04059588).
- | D2C7 / Istari Oncology
New P1 trial, New P1/2 trial: D2C7-IT + 2141-V11 Combination Post-resection in rGBM (clinicaltrials.gov) - Jun 12, 2024
P1/2, N=46, Not yet recruiting, Sponsor: Darell Bigner
- | Enrollment change, Trial completion date, Trial primary completion date: Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment (clinicaltrials.gov) - May 9, 2024
P1, N=55, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
These findings support the safety and efficacy of 2141-V11, warranting phase 2 studies and suggesting a unique mechanism of action for this Fc-enhanced immunotherapy (NCT04059588). N=25 --> 55 | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
- 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Phase I study of intravesical Fc-optimized anti-CD40 agonist antibody 2141-V11 for non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (221B) - Apr 17, 2024 - Abstract #AUA2024AUA_4120;
P1
Intravesical 2141-V11 is well tolerated up to 70 mg with minimal local side effects and no evidence of systemic toxicity. Completion of accrual and biological correlatives will reveal on-target activity and early efficacy data.
- | New P2 trial, Combination therapy, Monotherapy, Metastases: A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer (clinicaltrials.gov) - Apr 4, 2024
P2, N=99, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Phase I study of intravesical Fc-optimized anti-CD40 agonist antibody 2141-V11 for non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) therapy (Section 49) - Mar 5, 2024 - Abstract #AACR2024AACR_3885;
Completion of accrual and biological correlatives will reveal on-target activity and early efficacy data. Abstract is embargoed at this time.
- | D2C7 / Istari Oncology
Trial primary completion date, Combination therapy: Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma (clinicaltrials.gov) - Jan 29, 2024
P1, N=30, Recruiting, Sponsor: Annick Desjardins, MD
Abstract is embargoed at this time. Trial primary completion date: Dec 2023 --> Dec 2024
- | D2C7 / Istari Oncology
Enrollment open: D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients (clinicaltrials.gov) - Sep 21, 2023
P1/2, N=50, Recruiting, Sponsor: Darell Bigner
Trial primary completion date: Dec 2023 --> Dec 2024 Not yet recruiting --> Recruiting
- | 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Journal: IL-15 synergizes with CD40 agonist antibodies to induce durable immunity against bladder cancer. (Pubmed Central) - Aug 26, 2023
Collectively, these data reveal an important role for IL-15 in mediating antitumor CD40 agonist responses in bladder cancer and provide key proof-of-concept for combined use of Fc-optimized anti-CD40 agonist antibodies and agents targeting the IL-15 pathway. These data support expansion of ongoing clinical studies evaluating anti-CD40 agonist antibodies and IL-15-based approaches to develop combinations of these promising therapeutics for the treatment of patients with bladder cancer.
- | D2C7 / Istari Oncology
Trial initiation date: D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients (clinicaltrials.gov) - Jul 20, 2023
P1/2, N=50, Not yet recruiting, Sponsor: Darell Bigner
These data support expansion of ongoing clinical studies evaluating anti-CD40 agonist antibodies and IL-15-based approaches to develop combinations of these promising therapeutics for the treatment of patients with bladder cancer. Initiation date: May 2023 --> Aug 2023
- | 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin (clinicaltrials.gov) - Apr 13, 2023
P1, N=16, Completed, Sponsor: Rockefeller University
Initiation date: May 2023 --> Aug 2023 Recruiting --> Completed | N=28 --> 16 | Trial completion date: Jul 2025 --> Mar 2023 | Trial primary completion date: Jul 2025 --> Mar 2023
- | Trial completion date, Trial primary completion date: Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment (clinicaltrials.gov) - Feb 21, 2023
P1, N=25, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Recruiting --> Completed | N=28 --> 16 | Trial completion date: Jul 2025 --> Mar 2023 | Trial primary completion date: Jul 2025 --> Mar 2023 Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
- | D2C7 / Istari Oncology
New P1/2 trial: D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients (clinicaltrials.gov) - Feb 21, 2023
P1/2, N=50, Not yet recruiting, Sponsor: Darell Bigner
- D2C7 / Istari Oncology, 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Dose escalation trial of Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) administered intratumorally with D2C7-IT via Convection-Enhanced Delivery (CED) for Recurrent Malignant Gliomas (rMGs) (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_445;
Eligibility includes adult patients with solitary supratentorial rMG (WHO grade 3/4); ≥ 4 weeks after chemotherapy, bevacizumab, or study drug; adequate organ function; and KPS ≥ 70%. Intratumoral administration of D2C7-IT+2141-V11 via CED is safe, encouraging efficacy results are observed.
- | 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Trial primary completion date: A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin (clinicaltrials.gov) - Mar 17, 2022
P1, N=28, Recruiting, Sponsor: Rockefeller University
Intratumoral administration of D2C7-IT+2141-V11 via CED is safe, encouraging efficacy results are observed. Trial primary completion date: Jul 2023 --> Jul 2025
- | New P1 trial: Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment (clinicaltrials.gov) - Nov 18, 2021
P1, N=25, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- | D2C7 / Istari Oncology
Enrollment open, Combination therapy: Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma (clinicaltrials.gov) - May 11, 2021
P1, N=30, Recruiting, Sponsor: Darell Bigner
Trial primary completion date: Jul 2023 --> Jul 2025 Not yet recruiting --> Recruiting
- | 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Trial completion date, Trial primary completion date: A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin (clinicaltrials.gov) - Mar 2, 2021
P1, N=28, Recruiting, Sponsor: Rockefeller University
Not yet recruiting --> Recruiting Trial completion date: Jul 2023 --> Jul 2025 | Trial primary completion date: Jul 2021 --> Jul 2023
- | D2C7 / Istari Oncology
New P1 trial, Combination therapy: Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma (clinicaltrials.gov) - Sep 13, 2020
P1, N=30, Not yet recruiting, Sponsor: Darell Bigner
- | 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
Enrollment open: A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin (clinicaltrials.gov) - Aug 28, 2019
P1, N=28, Recruiting, Sponsor: Rockefeller University
Trial completion date: Jul 2023 --> Jul 2025 | Trial primary completion date: Jul 2021 --> Jul 2023 Not yet recruiting --> Recruiting
- | 2141-V11 - Memorial Sloan / Kettering Cancer Center, Rockefeller University
New P1 trial: A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin (clinicaltrials.gov) - Aug 15, 2019
P1, N=28, Not yet recruiting, Sponsor: Rockefeller University