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1 Disease | | 6 Products |
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- | DFF332 / Novartis
Trial completion date, Trial primary completion date, IO biomarker: CDFF332A12101: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov) - Jan 9, 2025
P1, N=40, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Feb 2025 --> Sep 2025 | Trial primary completion date: Feb 2025 --> Sep 2025
- PBF-680 / Palobiofarma
PBF-680, an oral A1 adenosine receptor antagonist, increases trough forced expiratory volume in 1 second (FEV1) in mild-to-moderate asthma: a Phase-II trial (PS-10; Poster board no. 14) - May 31, 2024 - Abstract #ERS2024ERS_3006;
Remarkably, PBF-680 significantly reduces circulating eosinophils. These data support the potential of PBF-680 as a promising oral anti-inflammatory asthma therapy.
- ||| PBF-680 / Palobiofarma
Trial completion, Enrollment change, Trial completion date: Respire: Therapeutic Effect of PBF-680 in Patients With COPD (clinicaltrials.gov) - Apr 19, 2024
P2, N=174, Completed, Sponsor: Palobiofarma SL
These data support the potential of PBF-680 as a promising oral anti-inflammatory asthma therapy. Active, not recruiting --> Completed | N=102 --> 174 | Trial completion date: Aug 2024 --> Apr 2024
- | Opdivo (nivolumab) / BMS, PBF-1129 / Palobiofarma
Enrollment open: PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 15, 2024
P1, N=30, Recruiting, Sponsor: Dwight Owen
Active, not recruiting --> Completed | N=102 --> 174 | Trial completion date: Aug 2024 --> Apr 2024 Suspended --> Recruiting
- | DFF332 / Novartis
Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases, Immuno-oncology: CDFF332A12101: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov) - Mar 14, 2024
P1, N=40, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Suspended --> Recruiting Trial completion date: Jul 2025 --> Feb 2025 | Trial primary completion date: Jul 2025 --> Feb 2025
- | Opdivo (nivolumab) / BMS, PBF-1129 / Palobiofarma
Trial suspension: PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 15, 2024
P1, N=30, Suspended, Sponsor: Dwight Owen
Trial completion date: Jul 2025 --> Feb 2025 | Trial primary completion date: Jul 2025 --> Feb 2025 Recruiting --> Suspended
- | PBF-1129 / Palobiofarma
Trial completion date, Trial primary completion date, Metastases: PBF-1129 in Patients With NSCLC (clinicaltrials.gov) - Feb 15, 2024
P1, N=18, Active, not recruiting, Sponsor: Palobiofarma SL
Recruiting --> Suspended Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Oct 2023 --> May 2024
- || PBF-680 / Palobiofarma
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: Respire: Therapeutic Effect of PBF-680 in Patients With COPD (clinicaltrials.gov) - Feb 9, 2024
P2, N=102, Active, not recruiting, Sponsor: Palobiofarma SL
Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Oct 2023 --> May 2024 Recruiting --> Active, not recruiting | Phase classification: P2a --> P2 | Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Dec 2023 --> May 2024
- || DFF332 / Novartis
Enrollment closed, Enrollment change, Combination therapy, IO biomarker, Metastases, Immuno-oncology: CDFF332A12101: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov) - Dec 22, 2023
P1, N=40, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Phase classification: P2a --> P2 | Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Dec 2023 --> May 2024 Recruiting --> Active, not recruiting | N=180 --> 40
- |||| taminadenant (NIR178) / Novartis, KAZ954 / Novartis, spartalizumab (PDR001) / Novartis
Trial termination, Combination therapy, IO biomarker, Metastases: KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov) - Sep 25, 2023
P1, N=77, Terminated, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | N=180 --> 40 Active, not recruiting --> Terminated; Business reasons
- taminadenant (NIR178) / Novartis, KAZ954 / Novartis, spartalizumab (PDR001) / Novartis
A Phase 1/1b study of KAZ954 alone and in combination with spartalizumab (PDR001) and taminadenant (NIR178) in patients with advanced gastrointestinal malignancies. (LEVEL 2, EXHIBIT HALL D) - Sep 16, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_434;
- || taminadenant (NIR178) / Novartis, KAZ954 / Novartis, spartalizumab (PDR001) / Novartis
Enrollment closed, Enrollment change, Combination therapy, IO biomarker, Metastases: KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov) - Sep 15, 2023
P1, N=77, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Terminated; Business reasons Recruiting --> Active, not recruiting | N=145 --> 77
- || taminadenant (NIR178) / Novartis, KAZ954 / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases: KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov) - Jul 31, 2023
P1, N=145, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | N=145 --> 77 Trial completion date: Feb 2025 --> Sep 2023 | Trial primary completion date: Feb 2025 --> Sep 2023
- || taminadenant (NIR178) / Novartis, KAZ954 / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases: KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov) - Jun 18, 2023
P1, N=145, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Feb 2025 --> Sep 2023 | Trial primary completion date: Feb 2025 --> Sep 2023 Trial completion date: Aug 2024 --> Feb 2025 | Trial primary completion date: Aug 2024 --> Feb 2025
- | PBF-1129 / Palobiofarma
Biomarker, Journal, Combination therapy, Tumor microenvironment, PD(L)-1 Biomarker, IO biomarker: Improving combination therapies: Targeting A2B adenosine receptor to modulate metabolic tumor microenvironment and immunosuppression. (Pubmed Central) - May 17, 2023
Trial completion date: Aug 2024 --> Feb 2025 | Trial primary completion date: Aug 2024 --> Feb 2025 Data identify A2BAR as a valuable therapeutic target to modify metabolic and immune TME to reduce immunosuppression, enhance the efficacy of immunotherapies, and support clinical application of PBF-1129 in combination therapies.
- ||| Zolinza (vorinostat) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD), taminadenant (NIR178) / Novartis
Biomarker, Clinical data, Journal, Adverse events, PD(L)-1 Biomarker, IO biomarker, Metastases: Early Adverse Event Derived Biomarkers in Predicting Clinical Outcomes in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunotherapy. (Pubmed Central) - May 13, 2023
Moreover, the methodology of the AE-derived biomarkers could change current AE analysis practice from a descriptive summary into modern informative statistics. It modernizes AE data analysis by helping clinicians discover novel AE biomarkers to predict clinical outcomes and facilitate the generation of vast clinically meaningful research hypotheses in a new AE content to fulfill the demands of precision medicine.
- |||||| taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Trial termination, Combination therapy, Metastases: CNIR178X2201: A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov) - Apr 13, 2023
P2, N=317, Terminated, Sponsor: Novartis Pharmaceuticals
It modernizes AE data analysis by helping clinicians discover novel AE biomarkers to predict clinical outcomes and facilitate the generation of vast clinically meaningful research hypotheses in a new AE content to fulfill the demands of precision medicine. Active, not recruiting --> Terminated; Sponsor decision
- |||| Trial termination, IO biomarker: Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov) - Feb 24, 2023
P1, N=64, Terminated, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Terminated; Sponsor decision Active, not recruiting --> Terminated; This was a sponsor decision and was not a consequence of any safety concern
- || PBF-1129 / Palobiofarma
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: PBF-1129 in Patients With NSCLC (clinicaltrials.gov) - Jan 26, 2023
P1, N=18, Active, not recruiting, Sponsor: Palobiofarma SL
Active, not recruiting --> Terminated; This was a sponsor decision and was not a consequence of any safety concern Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Oct 2023
- ||| PBF-999 / Palobiofarma
Trial completion, Enrollment change, Metastases: Study of PBF-999 in Solid Tumour Advanced Cancer (clinicaltrials.gov) - Jan 26, 2023
P1, N=54, Completed, Sponsor: Palobiofarma SL
Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Oct 2023 Recruiting --> Completed | N=40 --> 54
- || Trial completion date, Trial primary completion date, IO biomarker: Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov) - Nov 21, 2022
P1, N=64, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed | N=40 --> 54 Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
- |||| taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Trial termination, Combination therapy, Metastases: A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies. (clinicaltrials.gov) - Nov 4, 2022
P1, N=127, Terminated, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Terminated; After review of data which showed low likelihood of efficacy in these patients Novartis decided to terminate the trial early. Termination was not safety related
- taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Phase II study of taminadenant (A2AR antagonist) + spartalizumab (anti PD-1 antibody) in patients with triple negative breast cancer (TNBC) (Foyer mezzanine) - Oct 21, 2022 - Abstract #ESMOIO2022ESMO_IO_354;
P2
Conclusions TAM + spartalizumab showed clinical benefit in a fraction of pts with relapsed TNBC. Biomarker data support the role of TAM in shifting the immune microenvironment toward a "T-cell–inflamed" tumor, and possibly in increasing the efficacy of anti–PD-1 agents.
- | Opdivo (nivolumab) / BMS, PBF-1129 / Palobiofarma
Enrollment open: PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Oct 17, 2022
P1, N=30, Recruiting, Sponsor: Dwight Owen
Biomarker data support the role of TAM in shifting the immune microenvironment toward a "T-cell–inflamed" tumor, and possibly in increasing the efficacy of anti–PD-1 agents. Not yet recruiting --> Recruiting
- PBF-1129 / Palobiofarma
Phase 1 dose escalation trial of the selective A2B adenosine receptor antagonist PBF-1129 in patients with metastatic non-small cell lung cancer (mNSCLC). (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_914;
P1
Trial Registration NCT03274479 Ethics Approval The study was approved by the OSU institution's Ethics Board (#2018C0019) Consent All study participants granted a written informed consent prior to treatment initiation. Download figure Open in new tab Download powerpoint Abstract 585 Figure 1 PBF11-29 pharmacokineticsMean Concentrations of PBF-1129 Following Once Daily Oral Administration of PBF-1129
- | Opdivo (nivolumab) / BMS, PBF-1129 / Palobiofarma
Trial initiation date: PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 30, 2022
P1, N=30, Not yet recruiting, Sponsor: Dwight Owen
Download figure Open in new tab Download powerpoint Abstract 585 Figure 1 PBF11-29 pharmacokineticsMean Concentrations of PBF-1129 Following Once Daily Oral Administration of PBF-1129 Initiation date: Apr 2022 --> Nov 2022
- || taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies. (clinicaltrials.gov) - Aug 2, 2022
P1, N=127, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Initiation date: Apr 2022 --> Nov 2022 Recruiting --> Active, not recruiting | N=344 --> 127 | Trial completion date: Mar 2023 --> Sep 2022 | Trial primary completion date: Mar 2023 --> Sep 2022
- || Trial completion date, Trial primary completion date, IO biomarker: Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov) - Jul 19, 2022
P1, N=64, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | N=344 --> 127 | Trial completion date: Mar 2023 --> Sep 2022 | Trial primary completion date: Mar 2023 --> Sep 2022 Trial completion date: Jun 2022 --> Oct 2022 | Trial primary completion date: Jun 2022 --> Oct 2022
- || taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Trial primary completion date, Combination therapy, Metastases: A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies. (clinicaltrials.gov) - Jun 21, 2022
P1, N=344, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jun 2022 --> Oct 2022 | Trial primary completion date: Jun 2022 --> Oct 2022 Trial primary completion date: Sep 2022 --> Mar 2023
- || taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
P1 data, Journal: Phase I study of taminadenant (PBF509/NIR178), an adenosine 2A receptor antagonist, with or without spartalizumab, in patients with advanced non-small cell lung cancer. (Pubmed Central) - Jun 4, 2022
The maximum tolerated dose of taminadenant alone was 480 mg twice-daily, and 240 mg twice-daily plus spartalizumab. Efficacy was neither a primary or secondary endpoint; however, some clinical benefit was noted regardless of prior immunotherapy or programmed cell death ligand-1 status.
- ||| taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Enrollment closed, Combination therapy, Metastases: CNIR178X2201: A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov) - Apr 12, 2022
P2, N=317, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Efficacy was neither a primary or secondary endpoint; however, some clinical benefit was noted regardless of prior immunotherapy or programmed cell death ligand-1 status. Recruiting --> Active, not recruiting
- taminadenant (NIR178) / Novartis, NZV930 / Novartis, spartalizumab (PDR001) / Novartis
A phase I/Ib study of the safety and preliminary efficacy of NZV930 alone and in combination with spartalizumab and/or taminadenant in patients (pts) with advanced malignancies (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6683;
P1
The RDE of NZV930 SA or in combination with spartalizumab and/or taminadenant is 600 mg Q2W with a step-up dosing regimen. NZV930 SA and its combinations exhibited a tolerable safety profile in multiple advanced solid tumors and showed good PK properties.
- |||| PBF-680 / Palobiofarma
New P2a trial: Respire: Therapeutic Effect of PBF-680 in Patients With COPD (clinicaltrials.gov) - Mar 2, 2022
P2a, N=102, Recruiting, Sponsor: Palobiofarma SL
- || taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, Metastases: CNIR178X2201: A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov) - Feb 22, 2022
P2, N=376, Recruiting, Sponsor: Novartis Pharmaceuticals
NZV930 SA and its combinations exhibited a tolerable safety profile in multiple advanced solid tumors and showed good PK properties. Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Nov 2022
- | Opdivo (nivolumab) / BMS, PBF-1129 / Palobiofarma
New P1 trial: PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 9, 2022
P1, N=30, Not yet recruiting, Sponsor: Dwight Owen
- || Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, IO biomarker: Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov) - Jan 27, 2022
P1, N=64, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Nov 2022 Recruiting --> Active, not recruiting | N=220 --> 64 | Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> Jun 2022
- | PBF-999 / Palobiofarma
Trial completion date, Trial primary completion date, Metastases: Study of PBF-999 in Solid Tumour Advanced Cancer (clinicaltrials.gov) - Jan 13, 2022
P1, N=40, Recruiting, Sponsor: Palobiofarma SL
Recruiting --> Active, not recruiting | N=220 --> 64 | Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> Jun 2022 Trial completion date: Feb 2022 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Apr 2022
- ||| PBF-677 / Palobiofarma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: ADENOIBD: Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients (clinicaltrials.gov) - Jan 13, 2022
P2a, N=34, Completed, Sponsor: Palobiofarma SL
Trial completion date: Feb 2022 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Apr 2022 Recruiting --> Completed | N=50 --> 34 | Trial completion date: Oct 2021 --> May 2021 | Trial primary completion date: Aug 2021 --> May 2021
- ||| taminadenant (NIR178) / Novartis
Trial completion, Phase classification, Trial completion date, Trial primary completion date, Combination therapy, Metastases: AdenONCO: Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Jan 12, 2022
P1, N=92, Completed, Sponsor: Palobiofarma SL
Recruiting --> Completed | N=50 --> 34 | Trial completion date: Oct 2021 --> May 2021 | Trial primary completion date: Aug 2021 --> May 2021 Active, not recruiting --> Completed | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2020 --> Nov 2021 | Trial primary completion date: Oct 2020 --> Oct 2021
- || taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies. (clinicaltrials.gov) - Nov 23, 2021
P1, N=344, Recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2020 --> Nov 2021 | Trial primary completion date: Oct 2020 --> Oct 2021 Trial completion date: Feb 2022 --> Apr 2023 | Trial primary completion date: Jan 2022 --> Sep 2022
- ||| DFF332 / Novartis
Enrollment open, Combination therapy, IO biomarker, Metastases, Immuno-oncology: CDFF332A12101: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov) - Oct 24, 2021
P1, N=180, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Feb 2022 --> Apr 2023 | Trial primary completion date: Jan 2022 --> Sep 2022 Not yet recruiting --> Recruiting
- || taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, Metastases: CNIR178X2201: A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov) - Aug 18, 2021
P2, N=376, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Trial completion date: Jun 2023 --> Jun 2022 | Trial primary completion date: Jun 2023 --> Mar 2022
- |||| PBF-680 / Palobiofarma
New P2 trial: A clinical trial to assess the effect of PBF-680 in patients with moderate to severe Chronic Obstructive Pulmonar Disease on top of standard medication. Ensayo cl (EUDRACT) - Aug 14, 2021
P2, N=102, Ongoing, Sponsor: Palobiofarma, S.L
- taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
[VIRTUAL] Phase (Ph) II study of taminadenant (NIR178) + spartalizumab (PDR001) in patients (pts) with microsatellite stable (MSS) colorectal cancer (CRC) () - Jul 22, 2021 - Abstract #ESMO2021ESMO_1799;
P2
Efficacy of taminadenant + spartalizumab showed 5 pts obtained clinical benefit (1 PR and 4 sustained SD with tumor shrinkage), with no difference in response between RAS-WT and RAS-Mt. Taminadenant + spartalizumab was well tolerated in pts with MSS CRC.
- ||| DFF332 / Novartis
New P1 trial, Combination therapy, IO biomarker, Metastases, Immuno-oncology: CDFF332A12101: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov) - May 19, 2021
P1, N=180, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- || taminadenant (NIR178) / Novartis
Clinical, PK/PD data, Journal: Development and validation of a LC-MS/MS method for the quantitative analysis of the adenosine A2a receptor antagonist NIR178 and its monohydroxy metabolite in human plasma: Application to clinical pharmacokinetics. (Pubmed Central) - Apr 27, 2021
The normalized recoveries of both NIR178 and NJI765 to that of their internal standards were consistent and reproducible with a CV% not greater than 8.0. This method was successfully applied to support pharmacokinetic studies in adult patients with cancer.
- || taminadenant (NIR178) / Novartis, spartalizumab (PDR001) / Novartis
Trial completion date, Trial primary completion date, Combination therapy, Metastases: CNIR178X2201: A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov) - Feb 24, 2021
P2, N=376, Recruiting, Sponsor: Novartis Pharmaceuticals
This method was successfully applied to support pharmacokinetic studies in adult patients with cancer. Trial completion date: Dec 2021 --> Jun 2023 | Trial primary completion date: Dec 2021 --> Jun 2023
- | PBF-999 / Palobiofarma
Trial completion date, Trial primary completion date, Metastases: Study of PBF-999 in Solid Tumour Advanced Cancer (clinicaltrials.gov) - Sep 19, 2020
P1, N=40, Recruiting, Sponsor: Palobiofarma SL
Trial completion date: Dec 2021 --> Jun 2023 | Trial primary completion date: Dec 2021 --> Jun 2023 Trial completion date: Dec 2019 --> Feb 2022 | Trial primary completion date: Oct 2019 --> Dec 2021
- | PBF-677 / Palobiofarma
Trial completion date, Trial primary completion date: ADENOIBD: Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients (clinicaltrials.gov) - Sep 19, 2020
P2a, N=50, Recruiting, Sponsor: Palobiofarma SL
Trial completion date: Dec 2019 --> Feb 2022 | Trial primary completion date: Oct 2019 --> Dec 2021 Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Jun 2020 --> Aug 2021
- | PBF-1129 / Palobiofarma
Trial completion date, Trial primary completion date, Metastases: PBF-1129 in Patients With NSCLC (clinicaltrials.gov) - Sep 19, 2020
P1, N=18, Recruiting, Sponsor: Palobiofarma SL
Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Jun 2020 --> Aug 2021 Trial completion date: Dec 2019 --> Jun 2023 | Trial primary completion date: Nov 2019 --> Dec 2022