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- CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (Grand Ballroom AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1805;
P1
Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: Advarra Pro00037736 (Moffitt Cancer Center), IRB 52744 (Stanford University School of Medicine), HRPO# 201905108 (Washington University School of Medicine), DF/HCC IRB# 19-374 (Massachusetts General Hospital), WIRB STUDY00008948 (University of Washington, Seattle), IRB 191714 (Vanderbilt University Medical Center Vanderbilt-Ingram Cancer Center), 2019-087 Karmanos Cancer Institute, WIRB 2000026098 (Yale Cancer Center), 2019-0578 (The University of Texas MD Anderson Cancer Center), WIRB 1908869642 (University of Arizona Cancer Center), WIRB IRB00112341(Winship Cancer Institute/Emory University), IRB 20-073 (Memorial Sloan Kettering Cancer Center), IRB00255391 (Johns Hopkins University School of Medicine), IRB(IRBMED) HUM00165746 (University of Michigan Comprehensive Cancer Center), IRB0001113 (US Oncology Inc./Affiliated Oncologists, LLC), WCG IRB00000533 (Gabrail Cancer Center), IRB000001113 (George Washington University Cancer Center).
- CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (George R. Brown Convention Center - Level 3 - Grand Ballroom C) - Oct 4, 2024 - Abstract #SITC2024SITC_1478;
P1
Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: Advarra Pro00037736 (Moffitt Cancer Center), IRB 52744 (Stanford University School of Medicine), HRPO# 201905108 (Washington University School of Medicine), DF/HCC IRB# 19-374 (Massachusetts General Hospital), WIRB STUDY00008948 (University of Washington, Seattle), IRB 191714 (Vanderbilt University Medical Center Vanderbilt-Ingram Cancer Center), 2019-087 Karmanos Cancer Institute, WIRB 2000026098 (Yale Cancer Center), 2019-0578 (The University of Texas MD Anderson Cancer Center), WIRB 1908869642 (University of Arizona Cancer Center), WIRB IRB00112341(Winship Cancer Institute/Emory University), IRB 20-073 (Memorial Sloan Kettering Cancer Center), IRB00255391 (Johns Hopkins University School of Medicine), IRB(IRBMED) HUM00165746 (University of Michigan Comprehensive Cancer Center), IRB0001113 (US Oncology Inc./Affiliated Oncologists, LLC), WCG IRB00000533 (Gabrail Cancer Center), IRB000001113 (George Washington University Cancer Center).
- || CUE-101 / Cue Biopharma, LG Chem
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Apr 30, 2024
P1, N=85, Active, not recruiting, Sponsor: Cue Biopharma
IRB reference numbers: Advarra Pro00037736 (Moffitt Cancer Center), IRB 52744 (Stanford University School of Medicine), HRPO# 201905108 (Washington University School of Medicine), DF/HCC IRB# 19-374 (Massachusetts General Hospital), WIRB STUDY00008948 (University of Washington, Seattle), IRB 191714 (Vanderbilt University Medical Center Vanderbilt-Ingram Cancer Center), 2019-087 Karmanos Cancer Institute, WIRB 2000026098 (Yale Cancer Center), 2019-0578 (The University of Texas MD Anderson Cancer Center), WIRB 1908869642 (University of Arizona Cancer Center), WIRB IRB00112341(Winship Cancer Institute/Emory University), IRB 20-073 (Memorial Sloan Kettering Cancer Center), IRB00255391 (Johns Hopkins University School of Medicine), IRB(IRBMED) HUM00165746 (University of Michigan Comprehensive Cancer Center), IRB0001113 (US Oncology Inc./Affiliated Oncologists, LLC), WCG IRB00000533 (Gabrail Cancer Center), IRB000001113 (George Washington University Cancer Center). Trial completion date: Dec 2023 --> May 2025 | Trial primary completion date: Sep 2023 --> Nov 2024
- Keytruda (pembrolizumab) / Merck (MSD), CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC). (S100a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3595;
P1
A median OS of 20.8 was observed in patients treated with CUE-101 monotherapy as post-platinum/CPI therapy. CUE-101 continues to demonstrate safety, tolerability and meaningful clinical benefit in patients with HPV16+ R/M HNSCC.
- | CUE-101 / Cue Biopharma, LG Chem
Trial completion date, Trial primary completion date, Surgery, Metastases: Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov) - Apr 16, 2024
P2, N=30, Recruiting, Sponsor: Washington University School of Medicine
CUE-101 continues to demonstrate safety, tolerability and meaningful clinical benefit in patients with HPV16+ R/M HNSCC. Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027
- Keytruda (pembrolizumab) / Merck (MSD), CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3rd line and in combination with pembrolizumab in 1st line recurrent/metastatic (R/M) HPV16+ head and neck cancer patients. (JW Marriott Desert Ridge Grand Canyon 6-8; Poster Screen #7) - Jan 24, 2024 - Abstract #MHNCS2024MHNCS_293;
Patients treated with CUE-101 monotherapy in 3L showed a long OS. CUE-101 and pembrolizumab combination resulted in an ORR of 47% and decrease in HPV16 cfDNA in the 1L treatment of patients with HPV16+ R/M HNSCC.
- Keytruda (pembrolizumab) / Merck (MSD), CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy in 3L and in combination with pembrolizumab in 1L recurrent/metastatic HPV16+ head and neck cancer patients (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1008;
Conclusions CUE-101 demonstrates safety, tolerability and results in clinical benefit. Patients treated with CUE-101 monotherapy in 3L showed a long OS and CUE-101 and pembrolizumab combination resulted in an ORR of 44% with a corresponding decrease in HPV16 cfDNA in the 1L treatment of patients with HPV16+ R/M HNSCC.
- || CUE-101 / Cue Biopharma, LG Chem
Enrollment closed, Trial primary completion date, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Sep 21, 2023
P1, N=85, Active, not recruiting, Sponsor: Cue Biopharma
Patients treated with CUE-101 monotherapy in 3L showed a long OS and CUE-101 and pembrolizumab combination resulted in an ORR of 44% with a corresponding decrease in HPV16 cfDNA in the 1L treatment of patients with HPV16+ R/M HNSCC. Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Sep 2023
- |||||| CUE-101 / Cue Biopharma, LG Chem
P2 data, Surgery: Going on now in Hall A until 4:15 p.m..! Don't miss Jesse Zaretsky, MD, PhD, one of @RPachynski oncology fellows, present the phase 2 trial of three schedules of CUE-101 administered before surgery or chemoradiotherapy poster at #ASCO23. @ASCO @WUSTLmed (Twitter) - Jun 5, 2023
- Keytruda (pembrolizumab) / Merck (MSD), CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. (On Demand | E451; Poster Bd # 5) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3898;
P1
We demonstrate safety and tolerability with encouraging PD signals and antitumor activity with monotherapy and in combination with pembrolizumab in HPV+ R/M HNSCC patients. Enrollment continues in the CUE-101 and pembrolizumab combination cohort.
- CUE-101 / Cue Biopharma, LG Chem
Phase 2 trial of three schedules of CUE-101 administered before surgery or chemoradiotherapy in HLA-A*0201 positive patients with HPV16+ OPSCC. (On Demand | Hall A; Poster Bd # 97a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3884;
P1, P2
A schedule will be considered active if immunologic activity is observed in ?3 patients. Clinical trial information: NCT04852328.
- || CUE-101 / Cue Biopharma, LG Chem
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Apr 11, 2023
P1, N=85, Recruiting, Sponsor: Cue Biopharma
Clinical trial information: NCT04852328. Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Jun 2023
- CUE-101 / Cue Biopharma, LG Chem
Circulating free HPV16 DNA as a potential biomarker for immunotherapy-based trials in HPV16+ head and neck squamous cell carcinoma (Section 43; Poster Board #8) - Mar 14, 2023 - Abstract #AACR2023AACR_4612;
P1
Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Jun 2023 Our data support the continued assessment of HPV16 cfDNA as an exploratory biomarker in patients receiving immunotherapy to better understand correlations with radiographic response assessments and overall clinical benefit.
- CUE-102 / Cue Biopharma, LG Chem
CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients with WT1+ malignancies (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1627;
P1
These results, together with its similarity to CUE-101, support its anticipated tolerability profile and potential for clinical efficacy in an ongoing Phase 1 clinical trial ( NCT05360680 ). Ethics Approval Studies using animals were conducted in accordance with guidelines established by the Smart Labs Institutional Animal Care and Use Committee under protocol 21SL09-0007.
- Keytruda (pembrolizumab) / Merck (MSD), CUE-101 / Cue Biopharma, LG Chem
A phase 1 study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1000;
Of the 10 evaluable patients treated with CUE-101 plus pembrolizumab, 3 patients experienced PR (2 confirmed) and 2 patients SD for ≥ 12 weeks. Conclusions CUE-101 has a manageable safety profile and demonstrates activity alone and in combination with pembrolizumab.
- | CUE-101 / Cue Biopharma, LG Chem
Trial completion date, Trial primary completion date, Surgery, Metastases: Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov) - Sep 8, 2022
P2, N=30, Recruiting, Sponsor: Washington University School of Medicine
Conclusions CUE-101 has a manageable safety profile and demonstrates activity alone and in combination with pembrolizumab. Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
- || CUE-101 / Cue Biopharma, LG Chem
Trial primary completion date, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Aug 4, 2022
P1, N=85, Recruiting, Sponsor: Cue Biopharma
Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025 Trial primary completion date: Jul 2022 --> Feb 2023
- Keytruda (pembrolizumab) / Merck (MSD), CUE-101 / Cue Biopharma, LG Chem
A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. (Available On Demand; 37) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2279;
P1
We demonstrate safety and tolerability with encouraging PD signals and antitumor activity. Enrollment continues in the combination cohort.
- || CUE-101 / Cue Biopharma, LG Chem
Enrollment open, Surgery, Metastases: Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov) - Dec 7, 2021
P2, N=30, Recruiting, Sponsor: Washington University School of Medicine
Enrollment continues in the combination cohort. Not yet recruiting --> Recruiting
- CUE-102 / Cue Biopharma, LG Chem
CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients with WT1+ malignancies (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_1086;
Conclusions CUE-102 elicits selective expansion of a WT1-specific population of cytotoxic CD8+ T cells both in vitro and in vivo. These results, together with its similarity to CUE-101, support its anticipated tolerability profile and potential for clinical efficacy in a Phase 1 trial planned to initiate in 2022.
- Keytruda (pembrolizumab) / Merck (MSD), CUE-101 / Cue Biopharma, LG Chem
A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_965;
P1
Conclusions CUE-101 is a novel immunotherapeutic demonstrating acceptable safety and tolerability with encouraging PD signals, supporting selective activation of tumor-specific T cells, and promising antitumor activity. Enrollment continues in both monotherapy and combination cohorts.
- CUE-101 / Cue Biopharma, LG Chem
Targeting engineered interleukin-2 (IL-2) to antigen specific T cells via novel biologic platforms (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_580;
Emerging clinical data from our lead candidate CUE-101, which targets HPV-specific T cells in 2L+ R/M HNSCCC, provides PoC for the approach and builds confidence for broad applications in numerous cancers...Conclusions The IST, NST, and RDI-STAT platforms provide novel opportunities for selective targeting of IL-2 to tumor-relevant T cells while avoiding global immune activation and cytokine release. The scalability and versatility of NSTs highlight the potential to target multiple TAA T cell responses, while RDI-STATs highlight a novel means to harness antiviral immunity against cancer, especially in cases where the tumor may escape immune detection due to loss of HLA.
- || CUE-101 / Cue Biopharma, LG Chem
New P2 trial, Surgery, Metastases: Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov) - Apr 20, 2021
P2, N=30, Not yet recruiting, Sponsor: Washington University School of Medicine
- | CUE-101 / Cue Biopharma
Journal: CUE-101, a Novel HPV16 E7-pHLA-IL-2-Fc Fusion Protein, Enhances Tumor Antigen Specific T Cell Activation for the Treatment of HPV16-Driven Malignancies. (Pubmed Central) - Jan 28, 2021
P1
The scalability and versatility of NSTs highlight the potential to target multiple TAA T cell responses, while RDI-STATs highlight a novel means to harness antiviral immunity against cancer, especially in cases where the tumor may escape immune detection due to loss of HLA. Consistent with its design, CUE-101 demonstrates selective expansion of an HPV16 E7-specific population of cytotoxic CD8T cells, a favorable safety profile, and in vitro and in vivo evidence supporting its potential for clinical efficacy in an ongoing Phase 1 trial (NCT03978689).
- ||||| CUE-101 / Cue Biopharma
Clinical, Monotherapy: #WinshipClinicalTrial Phase 1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Patients with HPV+ Recurrent/Metastatic HNSCC | CUE-101-01 PI: Nabil F. Saba, MD (@DrNabilSaba) #hncsm ➡️ https://t.co/AgTNUxZe5w (Twitter) - Oct 30, 2020
- CUE-101 / Cue Biopharma
[VIRTUAL] CUE-100 series Immuno-STATs from concept to the clinic: Leveraging protein engineering to stimulate and selectively deliver affinity-attenuated IL-2 to antigen-specific T cells () - Oct 14, 2020 - Abstract #SITC2020SITC_1581;
Conclusions The presented data suggests that CUE-100 series Immuno-STATs have the potential to enhance anti-tumor immune responses by inducing a robust antigen-specific, oligoclonal, polyfunctional T cell repertoire. Early validation of CUE-100 series Immuno-STATs is obtained through the emerging signs of pharmacodynamic and clinical activity in the ongoing Phase I trial with CUE-101.
- CUE-101 / Cue Biopharma
[VIRTUAL] A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer () - Oct 14, 2020 - Abstract #SITC2020SITC_1385;
P1
Neither the MTD nor the monotherapy RP2D have been established. PD and PK analyses are ongoing as dose escalation continues.
- CUE-101 / Cue Biopharma
[VIRTUAL] CUE-100 series Immuno-STATs from concept to the clinic: Leveraging protein engineering to stimulate and selectively deliver affinity-attenuated IL-2 to antigen-specific T cells () - Oct 14, 2020 - Abstract #SITC2020SITC_846;
Conclusions The presented data suggests that CUE-100 series Immuno-STATs have the potential to enhance anti-tumor immune responses by inducing a robust antigen-specific, oligoclonal, polyfunctional T cell repertoire. Early validation of CUE-100 series Immuno-STATs is obtained through the emerging signs of pharmacodynamic and clinical activity in the ongoing Phase I trial with CUE-101.
- CUE-101 / Cue Biopharma
[VIRTUAL] A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer () - Oct 14, 2020 - Abstract #SITC2020SITC_650;
P1
Neither the MTD nor the monotherapy RP2D have been established. PD and PK analyses are ongoing as dose escalation continues.
- || CUE-101 / Cue Biopharma, LG Chem
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Aug 24, 2020
P1, N=85, Recruiting, Sponsor: Cue Biopharma
PD and PK analyses are ongoing as dose escalation continues. N=50 --> 85 | Trial completion date: Nov 2022 --> Aug 2023 | Trial primary completion date: Jun 2021 --> Jul 2022
- CUE-101 / Cue Biopharma
CUE-101, a novel HPV16 E7:pMHC:IL-2:Fc fusion protein, enhances tumor antigen specific T cell activation for the treatment of HPV16-driven malignancies (Prince George's Exhibition Halls AB) - Oct 2, 2019 - Abstract #SITC2019SITC_1158;
N=50 --> 85 | Trial completion date: Nov 2022 --> Aug 2023 | Trial primary completion date: Jun 2021 --> Jul 2022 Consistent with its design, CUE-101 demonstrates selective expansion of an HPV16 E7(11-20)-specific population of cytotoxic CD8+ T cells in vitro and in vivo.
- | CUE-101 / Cue Biopharma, LG Chem
Enrollment open, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jul 31, 2019
P1, N=50, Recruiting, Sponsor: Cue Biopharma
Consistent with its design, CUE-101 demonstrates selective expansion of an HPV16 E7(11-20)-specific population of cytotoxic CD8+ T cells in vitro and in vivo. Not yet recruiting --> Recruiting
- | CUE-101 / Cue Biopharma, LG Chem
New P1 trial, Combination therapy, Monotherapy, Metastases: KEYNOTE-A78: A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jun 6, 2019
P1, N=50, Not yet recruiting, Sponsor: Cue Biopharma