An open-label Phase 1/2a study of oral BAL101553 in adult patients with advanced solid tumors and in adult patients with recurrent or progressive glioblastoma or high-grade glioma

Start Date10 Mar 2021

Sponsor / Collaborator

Basilea Pharmaceutica International Ltd.

NCT02895360 / CompletedPhase 1/2

An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors or Recurrent Glioblastoma

Single-agent, open-label, multi-center sequential dose escalation and expansion study of BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced or recurrent solid tumors or recurrent glioblastoma.

Start Date24 Aug 2016

Sponsor / Collaborator

Basilea Pharmaceutica AG

NCT02490800 / CompletedPhase 1/2

An Open-label Phase 1/2a Study of Oral BAL101553 in Adult Patients With Advanced Solid Tumors and in Adult Patients With Recurrent or Progressive Glioblastoma or High-grade Glioma

First in human, open-label, sequential dose escalation and expansion study of oral BAL101553 in adult patients with advanced solid tumors and adult patients with recurrent or progressive glioblastoma or high-grade glioma.

Start Date23 Jun 2015

Sponsor / Collaborator

Basilea Pharmaceutica AG

100 Clinical Results associated with Lisavanbulin

100 Translational Medicine associated with Lisavanbulin

100 Patents (Medical) associated with Lisavanbulin

Literatures (Medical) associated with Lisavanbulin

01 Apr 2023·Investigational new drugs

Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study

Article

Author: von Moos, Roger ; Engelhardt, Marc ; Roth, Patrick ; Lane, Heidi ; Haefliger, Simon ; Stathis, Anastasios ; Marszewska, Michalina ; Joerger, Markus ; Hottinger, Andreas F ; Kaindl, Thomas ; Hundsberger, Thomas

Abstract:

Purpose. Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862), a microtubule-destabilizing agent. The goal of this study (NCT02895360) was to characterize the safety, tolerability and antitumor activity of lisavanbulin administered as a 48-hour intravenous (IV) infusion at the recommended Phase 2 dose (RP2D) of 70 mg/m2. Results from the Phase 1 dose-escalation portion of the study identifying the RP2D have been previously reported. Here, we present the findings from the Phase 2a portion of this study. Methods. This multi-center, open-label study included patients with ovarian, fallopian-tube, or primary peritoneal cancer that was either platinum-resistant or refractory (11 patients), or with first recurrence of glioblastoma (12 patients). Lisavanbulin was administered as a 48-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle. Results. Lisavanbulin was well tolerated in both patient cohorts. Thirteen patients (56.5%) developed 49 adverse events assessed as related to study treatment. The majority were mild or moderate; four were grade 3/4. Sixteen SAEs were reported in nine patients (39.1%), with none considered related to study treatment. No AEs led to permanent treatment discontinuation. Three patients in the ovarian cancer cohort had stable disease with lesion size reductions after two cycles of treatment; in the glioblastoma cohort, one patient showed partial response with a > 90% glioblastoma area reduction as best response, and one patient had stable disease after eight cycles of treatment. Conclusion. This study demonstrated a favorable safety and tolerability profile of 48-hour continuous IV infusion of lisavanbulin in patients with solid extracranial tumors or glioblastoma. Clinicaltrials.gov registration: NCT02895360.

01 Jan 2023·American journal of cancer research

The microtubule-targeted agent lisavanbulin (BAL101553) shows anti-tumor activity in lymphoma models.

Article

Author: Bertoni, Francesco ; Engelhardt, Marc ; Forster-Gross, Nicole ; Aresu, Luca ; Cascione, Luciano ; Bachmann, Felix ; Risi, Giorgia ; Arribas, Alberto J ; Lane, Heidi ; Spriano, Filippo ; Napoli, Sara

Microtubules are major components of the cellular cytoskeleton, ubiquitously founded in all eukaryotic cells. They are involved in mitosis, cell motility, intracellular protein and organelle transport, and maintenance of cytoskeletal shape. Avanbulin (BAL27862) is a microtubule-targeted agent (MTA) that promotes tumor cell death by destabilization of microtubules. Due to its unique binding to the colchicine site of tubulin, differently from other MTAs, avanbulin has previously shown activity in solid tumor cell lines. Its prodrug, lisavanbulin (BAL101553), has shown early signs of clinical activity, especially in tumors with high EB1 expression. Here, we assessed the preclinical anti-tumor activity of avanbulin in diffuse large B cell lymphoma (DLBCL) and the pattern of expression of EB1 in DLBCL cell lines and clinical specimens. Avanbulin showed a potent in vitro anti-lymphoma activity, which was mainly cytotoxic with potent and rapid apoptosis induction. Median IC50 was around 10 nM in both ABC and GCB-DLBCL. Half of the cell lines tested showed an induction of apoptosis already in the first 24 h of treatment, the other half in the first 48 h. EB1 showed expression in DLBCL clinical specimens, opening the possibility for a cohort of patients that could potentially benefit from treatment with lisavanbulin. These data show the basis for further preclinical and clinical evaluation of lisavanbulin in the lymphoma field.

12 Mar 2022·Neuro-oncologyQ1 · MEDICINE

Preclinical modeling in glioblastoma patient-derived xenograft (GBM PDX) xenografts to guide clinical development of lisavanbulin—a novel tumor checkpoint controller targeting microtubules

Q1 · MEDICINE

Article

Author: Decker, Paul A ; He, Lihong ; Bakken, Katrina K ; Kosel, Matthew L ; Burgenske, Danielle M ; Sarkaria, Jann N ; Gampa, Gautham ; McSheehy, Paul ; Hu, Zeng ; Mladek, Ann C ; Vaubel, Rachael A ; Eckel-Passow, Jeanette E ; Kitange, Gaspar J ; Talele, Surabhi ; Pokorny, Jenny L ; Carlson, Brett L ; Schmitt-Hoffmann, Anne ; Giannini, Caterina ; Lane, Heidi A ; Schroeder, Mark A ; Bachmann, Felix ; Elmquist, William F

Abstract:

Background:

Glioblastoma (GBM) is an incurable disease with few approved therapeutic interventions. Radiation therapy (RT) and temozolomide (TMZ) remain the standards of care. The efficacy and optimal deployment schedule of the orally bioavailable small-molecule tumor checkpoint controller lisavanbulin alone, and in combination with, standards of care were assessed using a panel of IDH-wildtype GBM patient-derived xenografts.

Methods:

Mice bearing intracranial tumors received lisavanbulin +/−RT +/−TMZ and followed for survival. Lisavanbulin concentrations in plasma and brain were determined by liquid chromatography with tandem mass spectrometry, while flow cytometry was used for cell cycle analysis.

Results:

Lisavanbulin monotherapy showed significant benefit (P < .01) in 9 of 14 PDXs tested (median survival extension 9%-84%) and brain-to-plasma ratios of 1.3 and 1.6 at 2- and 6-hours postdose, respectively, validating previous data suggesting significant exposure in the brain. Prolonged lisavanbulin dosing from RT start until moribund was required for maximal benefit (GBM6: median survival lisavanbulin/RT 90 vs. RT alone 69 days, P = .0001; GBM150: lisavanbulin/RT 143 days vs. RT alone 73 days, P = .06). Similar observations were seen with RT/TMZ combinations (GBM39: RT/TMZ/lisavanbulin 502 days vs. RT/TMZ 249 days, P = .0001; GBM26: RT/TMZ/lisavanbulin 172 days vs. RT/TMZ 121 days, P = .04). Immunohistochemical analyses showed a significant increase in phospho-histone H3 with lisavanbulin treatment (P = .01).

Conclusions:

Lisavanbulin demonstrated excellent brain penetration, significant extension of survival alone or in RT or RT/TMZ combinations, and was associated with mitotic arrest. These data provide a strong clinical rationale for testing lisavanbulin in combination with RT or RT/TMZ in GBM patients.

News (Medical) associated with Lisavanbulin

20 Jun 2024

·www.biospace.com

Basilea partners oncology drug candidate lisavanbulin with Glioblastoma Foundation

Allschwil, Switzerland, June 20, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an asset purchase agreement with the Glioblastoma Foundation Inc., for Basilea’s oncology drug candidate lisavanbulin (BAL101553), which has been developed as a potential therapy for glioblastoma, the most common type of primary brain cancer.1 Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Glioblastoma is one of the most lethal types of brain cancer and available therapeutic options are very limited. Partnering lisavanbulin with the Glioblastoma Foundation is important to us, as it enables patients to continue having access to this promising anticancer drug candidate, now that Basilea has changed its strategic focus to anti-infectives.” Dr. Gita Kwatra, Chief Executive Officer of the Glioblastoma Foundation, said: “We are delighted to partner with Basilea and take over the development of lisavanbulin for glioblastoma patients. Lisavanbulin has shown excellent activity against glioblastoma in PDX preclinical models as well as efficacy in phase 1 and 2 studies. We strongly believe that lisavanbulin will be effective in a subset of glioblastoma patients and we are looking forward to initiating clinical trials of lisavanbulin in the US.” Under the terms of the agreement, Basilea sells and transfers all rights to lisavanbulin to the Glioblastoma Foundation for an undisclosed initial purchase price. In addition, Basilea will participate in future proceeds from any potential commercial partnerships at a fixed double-digit percentage. The Glioblastoma Foundation will continue the post-trial access program for patients from previous clinical studies to continue to receive lisavanbulin. Also, the Glioblastoma Foundation will further explore the therapeutic value of lisavanbulin for the treatment of glioblastoma. About lisavanbulin (BAL101553) Lisavanbulin (BAL101553, the prodrug of BAL27862)2, has been investigated as a potential therapy for glioblastoma in clinical phase 1 and 2 studies.3, 4, 5 In preclinical studies, lisavanbulin demonstrated in-vitro and in-vivo activity against diverse treatment-resistant cancer models, including tumors refractory to conventional approved therapeutics and radiotherapy.6, 7, 8 Lisavanbulin efficiently distributes to the brain, with anticancer activity in glioblastoma models.9, 10 The active moiety, BAL27862, binds to the colchicine site of tubulin, with distinct effects on microtubule organization,11 resulting in the activation of the "spindle assembly checkpoint" which promotes tumor cell death.12 Lisavanbulin has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of malignant glioma (brain cancer), including glioblastoma. About Glioblastoma Foundation The mission of the Glioblastoma Foundation is to transform the standard of care for glioblastoma. It is based in Durham, North Carolina (USA) and supports the development of new drugs and other effective therapies for glioblastoma. Because each glioblastoma is different, it is likely that no one drug will work for everyone, and any therapies for glioblastoma will need to be targeted. The Glioblastoma Foundation supports the development of targeted therapies for glioblastoma. The organization also provides support for patients, and raises awareness of glioblastoma. For more information, please visit glioblastomafoundation.org. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from . References B. M. Alexander, T. F. Cloughesy. Adult Glioblastoma. Journal of Clinical Oncology 2017 (35), 2402-2409 J. Pohlmann, F. Bachmann, A. Schmitt-Hoffmann et al. BAL101553: An optimized prodrug of the microtubule destabilizer BAL27862 with superior antitumor activity. Cancer Research 2011, 71 (8 supplement), abstract 1347 ClinicalTrials.gov identifier: NCT03250299 ClinicalTrials.gov identifier: NCT02895360; M. Joerger, T. Hundsberger, S. Haefliger et al. Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study. Investigational New Drugs 2023 (41), 267-275 ClinicalTrials.gov identifier: NCT02490800; J. S. Lopez, S. Häfliger, R. Plummer et al. Evaluation of response-predictive biomarkers for lisavanbulin: A phase II study in patients with recurrent glioblastoma. ESMO Open 2023, Vol 8, 1, Suppl 2, 100941. A. Sharma, A. Broggini-Tenzer, V. Vuong et al. The novel microtubule targeting agent BAL101553 in combination with radiotherapy in treatment-refractory tumor models. Radiotherapy Oncology 2017 (124), 433-438 G. E. Duran, H. Lane, F. Bachmann et al. In vitro activity of the novel tubulin active agent BAL27862 in MDR1(+) and MDR1(-) human breast and ovarian cancer variants selected for resistance to taxanes. Cancer Research 2010, 70 (8 supplement), abstract 4412 F. Bachmann, K. Burger, G. E. Duran et al. BAL101553 (prodrug of BAL27862): A unique microtubule destabilizer active against drug refractory breast cancers alone and in combination with trastuzumab. Cancer Research 2014, 74 (19 supplement), abstract 831 A. Schmitt-Hoffmann, D. Klauer, K. Gebhardt et al. BAL27862: a unique microtubule-targeted agent with a potential for the treatment of human brain tumors. Molecular Cancer Therapeutics 2009, 8 (12 supplement), C233 A. C. Mladek, J. L. Pokorny, H. Lane et al. The novel tubulin-binding 'tumor checkpoint controller' BAL101553 has anti-cancer activity alone and in combination treatments across a panel of GBM patient-derived xenografts. Cancer Research 2016, 76 (14 supplement), abstract 4781 A. E. Prota, F. Danel, F. Bachmann et al. The novel microtubule-destabilizing drug BAL27862 binds to the colchicine site of tubulin with distinct effects on microtubule organization. Journal of Molecular Biology 2014 (426), 1848-1860 F. Bachmann, K. Burger, H. Lane. BAL101553 (prodrug of BAL27862): the spindle assembly checkpoint is required for anticancer activity. Cancer Research 2015, 75 (15 supplement), abstract 3789 Press release (PDF)

Orphan DrugPhase 1License out/inPhase 2Clinical Result

20 Jun 2024

·www.pharmaceutical-technology.com

Basilea sells rights to microtubule drug to Glioblastoma Foundation

Basilea joined an asset purchase agreement for its brain cancer therapy following a negative Phase II study. Credit: Taljat David via Shutterstock. Basilea has signed an asset purchase agreement with the Glioblastoma Foundation for the company’s glioblastoma candidate, lisavanbulin (BAL101553). Under the terms of the deal, Basilea will sell and transfer all rights for lisavanbulin to the charitable organisation for an undisclosed initial purchase cost. In the future, Basilea will continue to take part in any potential commercial partnerships at a fixed double-digit percentage. The Glioblastoma Foundation plans to take over lisavanbuilin’s post-access trial programme, allowing patients from previous clinical studies to continue receiving the drug. The charity will also oversee any further clinical studies investigating the use of lisavanbulin in glioblastoma. Lisavanbulin is a checkpoint inhibitor that binds to tubulin, which blocks the cell cycle and triggers cell death in cancer cells. The company was developing the drug for brain cancer, and the drug even received an US Food and Drug Administration orphan drug designation in 2021 for the treatment of malignant glioma, a type of brain cancer. However, after a disappointing Phase I/II trial (NCT02490800) readout, the Swiss pharmaceutical company decided not to expand the glioblastoma patient cohort for lisavanbulin in 2022. In the open-label study of nine patients with measurable disease at stage one, one patient demonstrated a partial response to lisavanbulin whilst another showed a 44% target lesion area reduction, as per an American Society of Clinical Oncology 2023 abstract. However, despite sustained activity in these subjects, they were unable to meet formal stage transition criteria leading to an early study completion. Glioblastomas are fast-growing brain tumours that are commonly treated through surgery radiotherapy and chemotherapy. According to the American Brain Tumor Association, glioblastomas make up approximately 14% of all primary brain tumors, with 12,000 cases diagnosed each year in the US. See Also: AZD-1705 by AstraZeneca for Dyslipidemia: Likelihood of Approval Sabestomig by AstraZeneca for Crohn’s Disease (Regional Enteritis): Likelihood of Approval In a 20 June press release, Dr Gita Kwatra, the Glioblastoma Foundation’s CEO, said, “We strongly believe that lisavanbulin will be effective in a subset of glioblastoma patients and we are looking forward to initiating clinical trials of lisavanbulin in the US.” The recent announcement marks Basilea’s second publicly declared deal of 2024. In January 2024, the company signed an agreement with Spexis to acquire its preclinical antibiotics programme. Before this, in October 2024, Basilea sought out a partner for its antibiotic ceftobiprole.

Orphan DrugClinical ResultPhase 2ASCO

13 Nov 2023

·www.fiercebiotech.com

Basilea continues pipeline fill-up by paying Pfizer $37M for Amplyx antifungal

A deal with Pfizer follows a busy few weeks that saw Basilea Pharmaceutica acquire an invasive mold infection drug from Gravitas Therapeutics and an endolysin antibacterial from Tonabacase. Only two and a half years after Pfizer acquired infectious disease biotech Amplyx for an undisclosed sum, the Big Pharma has sold the lead antifungal asset from that deal to Basilea Pharmaceutica. In its third deal in a month, Basilea is handing over $37 million upfront for the rights to the broad-spectrum antifungal, called fosmanogepix, as well as the rights to a preclinical antifungal compound. Today’s deal means the Swiss biotech will be liable to pay up to $110 million to Pfizer in commercial milestones should the drug reach the market. Basilea is also taking on the obligations and rights from previous agreements for the drug, which add up to $396 million in various development, regulatory and commercial milestone payments. Fosmanogepix has remained in phase 2 development for the treatment of a fungal disease called candidemia and invasive mold infections since Amplyx came under Pfizer’s wing, but Basilea plans to kick-start a phase 3 trial in mid-2024. Pfizer will retain the right of first negotiation for the commercial license to fosmanogepix if it clears phase 3 trials. It won’t be Basilea’s first interaction with Pfizer, however—the Big Pharma secured the Europe rights to Basilea’s approved antifungal Cresemba back in 2017 and also has the license in China. Basilea CEO David Veitch hailed today’s deal as a “transformative transaction for us.” As well as Cresemba, the company also owns the antibiotic Zevtera, and Veitch said gaining fosmanogepix “provides a strong commercial near-term opportunity beyond our currently marketed anti-infectives.” It follows a busy few weeks of dealmaking that saw Basilea acquire an invasive mold infection drug from Gravitas Therapeutics and an endolysin antibacterial from South Korea’s Tonabacase. “We have now executed three transactions over the course of the last few weeks that have significantly strengthened our clinical-stage portfolio, and we continue to see interesting opportunities for further transactions in the future,” Veitch added. The recent deals are the latest example of Basilea’s pivot away from oncology to focus solely on anti-infectives, a move that got off to a bumpy start at the beginning of the year when preclinical profiling of an antifungal program purchased from Fox Chase Chemical Diversity Center for an undisclosed fee led the company to hand the asset back. The terminated agreement was part of an overall restructuring at Basilea that also included the decision not to expand studies for lisavanbulin, a tumor checkpoint controller. Instead, the restructured company pivoted from oncology to focus solely on anti-infectives, such as Zevtera, which is already marketed in Europe and is now awaiting an FDA decision.

License out/inAcquisitionPhase 2

100 Deals associated with Lisavanbulin

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 2	CH	Basilea Pharmaceutica AG	01 Aug 2016
High grade glioma	Phase 2	BE	Basilea Pharmaceutica AG	23 Jun 2015
High grade glioma	Phase 2	DE	Basilea Pharmaceutica AG	23 Jun 2015
High grade glioma	Phase 2	CH	Basilea Pharmaceutica AG	23 Jun 2015
High grade glioma	Phase 2	GB	Basilea Pharmaceutica AG	23 Jun 2015
Recurrent Glioblastoma	Phase 2	BE	Basilea Pharmaceutica AG	23 Jun 2015
Recurrent Glioblastoma	Phase 2	DE	Basilea Pharmaceutica AG	23 Jun 2015
Recurrent Glioblastoma	Phase 2	CH	Basilea Pharmaceutica AG	23 Jun 2015
Recurrent Glioblastoma	Phase 2	GB	Basilea Pharmaceutica AG	23 Jun 2015
Advanced Malignant Solid Neoplasm	Phase 2	GB	Basilea Pharmaceutica AG	01 Jun 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03250299 (ABTC1601, ASCO2023) Manual	Phase 1	Glioblastoma First line MGMT Promoter Methylation Negative	26	Lisavanbulin	gqbxauyprs(snumrgtfhw) = jjdcyalxyn ibslijiwwv (tnzvlqdhqx ) View more	Positive	26 May 2023
NCT02490800 (ESMO_TAT2023) Manual	Phase 2	Recurrent Glioblastoma EB1 expression	19	lisavanbulin 25 mg	jixldtaddm(kmlbxfyujz) = meqvttqdec fyalzfoeyh (xevfavfyep ) View more	Positive	06 Mar 2023
NCT02895360 (Pubmed)	Phase 2	Ovarian Cancer \| Recurrent Glioblastoma	43	Lisavanbulin 70 mg/m2	bvvzgbsebo(lsbtwstkle) = Thirteen patients (56.5%) developed 49 adverse events assessed as related to study treatment. The majority were mild or moderate; four were grade 3/4. Sixteen SAEs were reported in nine patients (39.1%), with none considered related to study treatment. No AEs led to permanent treatment discontinuation. uuikgnvuco (uhibftujrr )	-	16 Feb 2023
NCT02490800 (ASCO2021)	Phase 2	Recurrent Glioblastoma	71	Lisavanbulin	dizvwbseip(tleinpfrsn) = Both patients show strong end-binding protein 1 (EB1) expression in their GB tissues as assessed by immunohistochemistry staining xmvkyphlal (bfnmuaqucp ) View more	-	28 May 2021
NCT02490800 (ESMO2020)	Phase 1	Recurrent Glioma	28	Lisavanbulin	ywurlmonqm(mijczisuyc) = bvykgnbudg pkyepasgov (kuwwahijdy ) View more	Positive	17 Sep 2020
NCT02895360 (Pubmed \| Invest New Drugs)	Phase 1	HR-positive/HER2-low Solid Tumors	43	BAL101553	ozaofjzbpm(utzlorqfnz) = gnnpsdwqfw byykrfqlev (kkllitvirn )	-	01 Aug 2020
NCT02895360 (ASCO2018)	Phase 1/2	HR-positive/HER2-low Solid Tumors	20	BAL101553	iqbvkidqrt(eyseavmzxf) = Adverse events (AEs) were assessed by CTCAEv4.03 grade (G) modamoxfzg (jotdplqikc )	-	01 Jun 2018
NCT02490800 (ASCO2018)	Phase 1/2	HR-positive/HER2-low Solid Tumors	26	BAL101553	cdolrjyain(lrcxtxrotp) = BAL101553 was generally well tolerated at doses ≤16 mg, with one G3 event of increased alkaline phosphatase not considered clinically significant and G1/G2 events that did not show organ-specific patterns. Dose-limiting toxicities were seen at doses ≥20 mg: G3–4 hyponatremia, G3 hypokalemia and G2 hallucinations (all reversible) jzzhrrdtzn (lecoigvtux )	-	01 Jun 2018
NCT02490800 (ASCO2017)	Phase 1/2	HR-positive/HER2-low Solid Tumors	19	BAL101553	fzzgcfirok(kfnjpznhxz) = wyxwcwaovo pulowehfjf (oqxtkgfmcf ) View more	-	30 May 2017
AACR2014	Phase 1	Breast Cancer	-	BAL101553	ytlchawbcy(ncnigqotlp) = osethdxnfc ebsztafljx (lsvhlrtxza ) View more	Positive	01 Oct 2014
AACR2014	Phase 1	Breast Cancer	-	Combination of BAL101553 and Trastuzumab	ylizrcxuwf(okadoltysj) = zayrwljfzl ebfrwrhwrq (jkglqvvryj )	Positive	01 Oct 2014

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