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- || gotistobart (BNT316) / OncoC4, BioNTech
Enrollment closed: PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - Oct 23, 2024
P2, N=58, Active, not recruiting, Sponsor: OncoC4, Inc.
Recruiting --> Active, not recruiting
- ||||| gotistobart (BNT316) / OncoC4, BioNTech
Enrollment closed, Metastases: PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov) - Oct 23, 2024
P3, N=600, Active, not recruiting, Sponsor: OncoC4, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- Keytruda (pembrolizumab) / Merck (MSD), gotistobart (BNT316) / OncoC4, BioNTech
A randomized, phase II, dose optimization of gotistobart, a pH-sensitive anti-CTLA-4, in combination with standard dose pembrolizumab in platinum-resistant recurrent ovarian cancer: Safety, efficacy and dose optimization (PRESERVE-004/GOG-3081) (Burgos Auditorium - Hall 5) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1602;
P2
Unconfirmed ORR was 31.8% (7/22; 95% CI 13.9-54.9) and 36.4% (8/22; 95% CI 17.2-59.3) in 1 mg/kg and 2 mg/kg groups, respectively. Conclusions Early results show encouraging safety and clinical activity in PROC patients receiving gotistobart + pembrolizumab.
- || gotistobart (BNT316) / OncoC4, BioNTech
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - May 12, 2024
P1/2, N=733, Recruiting, Sponsor: OncoC4, Inc.
Conclusions Early results show encouraging safety and clinical activity in PROC patients receiving gotistobart + pembrolizumab. Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Jun 2024 --> Jun 2026
- || gotistobart (BNT316) / OncoC4, BioNTech
Phase classification, Trial primary completion date, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Jan 16, 2024
P1/2, N=914, Recruiting, Sponsor: OncoC4, Inc.
Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Jun 2024 --> Jun 2026 Phase classification: P1a/1b --> P1/2 | Trial primary completion date: Dec 2023 --> Jun 2024
- ||| gotistobart (BNT316) / OncoC4, BioNTech
Enrollment open, Metastases: PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov) - Dec 8, 2023
P1/2, N=144, Recruiting, Sponsor: OncoC4, Inc.
Phase classification: P1a/1b --> P1/2 | Trial primary completion date: Dec 2023 --> Jun 2024 Not yet recruiting --> Recruiting
- ||| gotistobart (BNT316) / OncoC4, BioNTech
Phase classification, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Metastases: PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov) - Oct 11, 2023
P1/2, N=144, Not yet recruiting, Sponsor: OncoC4, Inc.
Not yet recruiting --> Recruiting Phase classification: P2 --> P1/2 | N=90 --> 144 | Trial completion date: Dec 2026 --> Jun 2027 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: Dec 2025 --> Jun 2026
- gotistobart (BNT316) / OncoC4, BioNTech
Single-agent safety and activities of target-preserving anti-CTLA-4 antibody gotistobart (ONC-392/BNT316) in PD-(L)1 resistant metastatic NSCLC and population PK analysis in patients with solid tumors (Ground Level - Exhibit Hall D - San Diego) - Sep 13, 2023 - Abstract #SITC2023SITC_67;
P1a/1b
Conclusions Gotistobart (ONC-392/BNT316) monotherapy at 10 mg/kg x 2 followed by 6 mg/kg, Q3W is safe and tolerable and appears to be the first anti-CTLA-4 mAb with significant single agent anti-tumor activity in IO-resistant NSCLC. Gotistobart has the desirable PK characteristics of long half-life and delayed clearance for an immunotherapy antibody.
- | Keytruda (pembrolizumab) / Merck (MSD)
Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: Pembrolizumab in mCRPC - Combination therapies as breakthrough to success? (Pubmed Central) - Aug 21, 2023
Gotistobart has the desirable PK characteristics of long half-life and delayed clearance for an immunotherapy antibody. ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC.
- || gotistobart (BNT316) / OncoC4, BioNTech, AI-061 / OncoC4
Enrollment open, Metastases: PRESERVE-009: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (clinicaltrials.gov) - Jul 13, 2023
P1, N=18, Recruiting, Sponsor: OncoC4, Inc.
ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC. Not yet recruiting --> Recruiting
- |||||| gotistobart (BNT316) / OncoC4, BioNTech
Enrollment open, Metastases: PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov) - May 31, 2023
P3, N=600, Recruiting, Sponsor: OncoC4, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || gotistobart (BNT316) / OncoC4, BioNTech, AI-061 / OncoC4
New P1 trial, Metastases: PRESERVE-009: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (clinicaltrials.gov) - May 15, 2023
P1, N=18, Not yet recruiting, Sponsor: OncoC4, Inc.
- BNT316 / OncoC4, BioNTech
Safety and clinical activity of target-preserving anti-CTLA-4 antibody ONC-392 as monotherapy in NSCLC patients who progressed on PD(L)1-targeted immunotherapy. (Live Stream | Hall D1; Poster Bd # 12) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3584;
P1a/1b, P3
Onc-392 monotherapy has showed encouraging anti-tumor activity in IO-resistant NSCLC when compared with historical data. Based on these encouraging data, we have initiated a Phase 3 study testing ONC-392 monotherapy among NSCLC who progressed on PD(L)1-targeting immunotherapy (NCT05671510).
- BNT316 / OncoC4, BioNTech
PRESERVE-003: Phase 3, two-stage, randomized study of ONC-392 versus docetaxel in metastatic non-small cell lung cancers that progressed on PD-1/PD-L1 inhibitors. (On Demand | Hall A; Poster Bd # 130b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3554;
P3
The analyses will be based on the ITT Population. Clinical trial information: NCT05671510.
- ||| ONC-392 / OncoC4, BioNTech
3/ The CTLA-4 asset BioNTech acquired is ONC-392. See here from #SITC21: https://t.co/PpYMHjy75r. (Twitter) - Mar 22, 2023
- || gotistobart (BNT316) / OncoC4, BioNTech
Enrollment change, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Mar 20, 2023
P1a/1b, N=914, Recruiting, Sponsor: OncoC4, Inc.
Clinical trial information: NCT05671510. N=468 --> 914
- |||| gotistobart (BNT316) / OncoC4, BioNTech
New P2 trial, Metastases: PRESERVE-006: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (clinicaltrials.gov) - Jan 12, 2023
P2, N=90, Not yet recruiting, Sponsor: OncoC4, Inc.
- |||||||||| gotistobart (BNT316) / OncoC4, BioNTech
New P3 trial, Metastases: PRESERVE-003: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors (clinicaltrials.gov) - Jan 4, 2023
P3, N=600, Not yet recruiting, Sponsor: OncoC4, Inc.
- ||| gotistobart (BNT316) / OncoC4, BioNTech
Enrollment open: PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - Dec 28, 2022
P2, N=58, Recruiting, Sponsor: OncoC4, Inc.
N=468 --> 914 Not yet recruiting --> Recruiting
- || gotistobart (BNT316) / OncoC4, BioNTech
Trial initiation date: PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - Dec 1, 2022
P2, N=58, Not yet recruiting, Sponsor: OncoC4, Inc.
Not yet recruiting --> Recruiting Initiation date: Sep 2022 --> Dec 2022
- Keytruda (pembrolizumab) / Merck (MSD), ONC-392 / OncoC4
Dose escalation of next generation Anti-CTLA-4 antibody ONC-392 in combination with fixed dose of pembrolizumab in patients with advanced solid tumors (Hall C) - Nov 3, 2022 - Abstract #SITC2022SITC_1836;
P1a/1b
The rate of irAE is low relative to drugs of the same class. These results support the feasibility to significantly increase drug exposure for full immunotherapeutic potential of anti-CTLA-4 and anti-PD-1 combination therapy.
- ONC-392 / OncoC4
Safety and clinical activities of the acid pH-sensitive anti-CTLA-4 mAb ONC-392 in ovarian cancer patients (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_895;
P1a/1b
The available data support continuous clinical testing of ONC-392 in ovarian cancer. A new Phase 2 study with combination of ONC-392 and pembrolizumab will initiated in Q32022 (ONC-392-004, MK3475-E24, GOG-3081).
- Keytruda (pembrolizumab) / Merck (MSD), ONC-392 / OncoC4
Dose escalation of next generation Anti-CTLA-4 antibody ONC-392 in combination with fixed dose of pembrolizumab in patients with advanced solid tumors (258ABC) - Aug 4, 2022 - Abstract #SITC2022SITC_206;
P1a/1b
The rate of irAE is low relative to drugs of the same class. These results support the feasibility to significantly increase drug exposure for full immunotherapeutic potential of anti-CTLA-4 and anti-PD-1 combination therapy.
- |||| gotistobart (BNT316) / OncoC4, BioNTech
New P2 trial: PRESERVE-004: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - Jul 5, 2022
P2, N=58, Not yet recruiting, Sponsor: OncoC4, Inc.
- || gotistobart (BNT316) / OncoC4, BioNTech
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Jan 11, 2022
P1a/1b, N=413, Recruiting, Sponsor: OncoC4, Inc.
These results support the feasibility to significantly increase drug exposure for full immunotherapeutic potential of anti-CTLA-4 and anti-PD-1 combination therapy. N=300 --> 413 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- ONC-392 / OncoC4
[VIRTUAL] First-in-human study of the first acid pH-sensitive and recycling CTLA-4 antibody that preserves the immune tolerance checkpoint to avoid immunotherapy-related adverse events in cancer patients (Poster Hall) - Oct 31, 2021 - Abstract #SITC2021SITC_1292;
P1a/1b
To test this new hypothesis in human, we initiated first-in-human study evaluating the safety and tolerability of ONC-392 in patients with advanced solid tumors...The acid pH-sensitive anti-CTLA-4 mAb that preserves CTLA-4 recycling and avoids lysosomal degradation was safe and well tolerated. Our work paves the way for significant increase of drug exposure to reach full immunotherapeutic potential of CTLA-4 targeting.
- Keytruda (pembrolizumab) / Merck (MSD), ONC-392 / OncoC4
An open label Phase IA/IB study for safety, pharmacokinetics (PK), and efficacy of ONC 392 as a single agent and in combination with Pembrolizumab in advanced solid tumors (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_460;
P1a/1b
The planned enrollment is 300 patients and the study duration is 18 months. Trial Registration NCT04140526
- ONC-392 / OncoC4
Pharmacokinetics of first and repeated dosing of non-irAE-inducing anti-CTLA-4 monoclonal antibody ONC-392 in advanced cancer patients (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_432;
Overall exposure is comparable or higher than those reported by others using different anti-CTLA-4 antibodies. The apparent lack of irAE in ONC-392 recipients despite the high exposure indicates intrinsic safety and tolerability of ONC-392.
- ONC-392 / OncoC4
Molecular Insights on safety and anti-tumor activity of a non-irAE-inducing anti-CTLA-4 monoclonal antibody ONC-392 (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_322;
P1a/1b
Therefore, lacking negative signaling from Fc?RIIB may also contribute to its anti-tumor activity. Trial Registration NCT04140526
- || gotistobart (BNT316) / OncoC4, BioNTech
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Aug 18, 2021
P1a/1b, N=300, Recruiting, Sponsor: OncoC4, Inc.
Trial Registration NCT04140526 N=91 --> 300 | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2022 --> Dec 2022
- ||| gotistobart (BNT316) / OncoC4, BioNTech
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Jul 23, 2020
P1a/1b, N=91, Recruiting, Sponsor: OncoImmune, Inc.
N=91 --> 300 | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2022 --> Dec 2022 Not yet recruiting --> Recruiting | Trial completion date: Feb 2023 --> Jul 2023 | Trial primary completion date: Feb 2022 --> Jul 2022
- ONC-392 / Pfizer
[VIRTUAL] First-in-human phase I/II clinical trial of ONC-392: Preserving CTLA-4 immune tolerance checkpoint for safer and more effective cancer immunotherapy. (Poster Board 223) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1429;
P1a/1b
The trial consists of a dose-finding, dose escalation or de-escalation, Phase IA component aimed at defining the recommended phase II dose for ONC-392 in combination with a standard dose of Pembrolizumab (RP2D-C), then progressing into two parallel, single arm, Phase IB expansion cohorts to test for safety and initial efficacy in two groups of patients with NSCLC: Stage IV NSCLC anti-PD(L)1 immunotherapy naïve with PD-L1-positive (PD-L1 TPS ≥ 1%); Stage IV NSCLC refractory/resistant to anti-PD(L)1 immunotherapy. Research Funding: U.S. National Institutes of Health, Pharmaceutical/Biotech Company
- || gotistobart (BNT316) / OncoC4, BioNTech
Trial initiation date, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Mar 20, 2020
P1a/1b, N=91, Not yet recruiting, Sponsor: OncoImmune, Inc.
Research Funding: U.S. National Institutes of Health, Pharmaceutical/Biotech Company Initiation date: Feb 2020 --> May 2020
- | gotistobart (BNT316) / OncoC4, BioNTech
Phase classification, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Jan 5, 2020
P1a/1b, N=91, Not yet recruiting, Sponsor: OncoImmune, Inc.
Initiation date: Feb 2020 --> May 2020 Phase classification: P1/2 --> P1a/1b
- |||| gotistobart (BNT316) / OncoC4, BioNTech
New P1 trial, New P1/2 trial, Combination therapy, Monotherapy, Metastases: PRESERVE-001: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (clinicaltrials.gov) - Nov 15, 2019
P1/2, N=91, Not yet recruiting, Sponsor: OncoImmune, Inc.