Study CX-659-401 is a multicenter, open-label, phase 2 study of mivavotinib to evaluate the single-agent activity of mivavotinib in patients with relapsed/refractory non-GCB/ABC DLBCL, incorporating ctDNA-based next-generation sequencing (NGS) to identify DLBCL patients harboring MyD88 and/or CD79B mutations within the study. This goal of this strategy is to evaluate its activity both in the cell-of-origin subgroup of non-GCB/ABC DLBCL and in the genetically defined subgroups of MyD88/CD79B-mutated and wild type DLBCL.

Start Date23 Jun 2022

Sponsor / Collaborator

Calithera Biosciences, Inc.

NCT04079738

/ TerminatedPhase 1/2

Phase I/II Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition of the Proteasome Inhibitor Ixazomib: Big Ten Cancer Research Consortium BTCRC-HEM17-092

This is a Phase I/II study augmenting TAK-659 action in relapsed/refractory AML by addition of the proteasome inhibitor Ixazomib. Phase I of the study will determine the safety, tolerability, and maximum tolerated dose (MTD) of the combination of TAK-659 and Ixazomib. During the phase I, dose escalation will be conducted according to a standard 3+3 dose escalation schema, and up to 18 response-evaluable patients will be enrolled. Phase II of the study will evaluate the efficacy of the combination by measuring the overall response rate (ORR).

Start Date20 Sep 2019

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT03772288

/ WithdrawnPhase 1

A Phase 1b Study of TAK-659 in Combination With NKTR-214 in Patients With Advanced Non-Hodgkin Lymphoma

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for TAK-659 when administered in combination with NKTR-214.

Start Date03 Apr 2019

Sponsor / Collaborator

Calithera Biosciences, Inc.

[+1]

100 Clinical Results associated with Mivavotinib

100 Translational Medicine associated with Mivavotinib

100 Patents (Medical) associated with Mivavotinib

Literatures (Medical) associated with Mivavotinib

01 Jun 2024·ESMO Open

A phase I study of TAK-659 and paclitaxel in patients with taxane-refractory advanced solid tumors

Article

Author: Fu, S ; Peng, J ; Karp, D ; Yang, P ; Yap, T A ; Tsimberidou, A M ; Piha-Paul, S A ; Liang, Y ; Meric-Bernstam, F ; Myers, A ; Yuan, Y ; Shunyakova, J ; Dumbrava, E ; Naing, A ; Gouda, M A ; Hong, D S ; Rodon, J

BACKGROUND:

Paclitaxel resistance limits durability of response in patients with initial clinical benefit. Overexpression of spleen tyrosine kinase (SYK) has been proposed as a possible resistance mechanism. This phase I trial evaluated the safety and preliminary activity of the SYK inhibitor TAK-659 combined with paclitaxel in patients with advanced taxane-refractory solid tumors.

PATIENTS AND METHODS:

Patients with advanced solid tumors and prior progression on taxane-based therapy received intravenous infusion of paclitaxel on days 1, 8, and 15 plus oral TAK-659 daily in 28-day cycles. The dose-escalation phase included six cohorts treated at different dose levels; the dose-expansion phase included patients with ovarian cancer treated at the highest dose level. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Efficacy was evaluated using Response Evaluation Criteria in Solid Tumors version 1.1.

RESULTS:

Our study included 49 patients. Maximum tolerated dose was not reached, but higher rates of adverse events were observed at higher dose levels. There were no treatment-related deaths. The most common treatment-related adverse events of any grade were increased aspartate aminotransferase (n = 31; 63%), increased alanine aminotransferase (n = 26; 53%), decreased neutrophil count (n = 26; 53%), and decreased white blood cell count (n = 26; 53%). Most adverse events were either grade 1 or 2. In the 44 patients with evaluable disease, 12 (27%) had stable disease as the best overall response, including three patients with prolonged stable disease, and 4 patients (9%) achieved a partial response.

CONCLUSIONS:

The combination of paclitaxel and TAK-659 showed preliminary activity possibly overcoming resistance to taxane-based therapy as well as a tolerable safety profile in patients with advanced solid tumors.

01 Mar 2024·Cancer medicine

A phase Ib study evaluating the recommended phase II dose, safety, tolerability, and efficacy of mivavotinib in combination with nivolumab in advanced solid tumors

Article

Author: Li, Cong ; Sappal, Jessica Huck ; Gregory, Richard C ; Riley, Jason ; Jañez, Noelia Martinez ; Kannan, Karuppiah ; Barve, Minal ; Olszanski, Anthony J ; Jiménez, Begoña ; Miao, Harry ; Harvey, R Donald ; Opyrchal, Mateusz ; Calvo, Aitana ; Juric, Dejan ; Roda, Desamparados ; Wang, Shining ; Thistlethwaite, Fiona ; Trigo, Jose ; Li, Cheryl ; Vaishampayan, Ulka ; Spira, Alexander ; Greystoke, Alastair

Abstract:

Mivavotinib (TAK‐659/CB‐659), a dual SYK/FLT3 inhibitor, reduced immunosuppressive immune cell populations and suppressed tumor growth in combination with anti‐PD‐1 therapy in cancer models. This dose‐escalation/expansion study investigated the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mivavotinib plus nivolumab in patients with advanced solid tumors. Patients received oral mivavotinib 60–100 mg once‐daily plus intravenous nivolumab 3 mg/kg on days 1 and 15 in 28‐day cycles until disease progression or unacceptable toxicity. The dose‐escalation phase evaluated the recommended phase II dose (RP2D; primary endpoint). The expansion phase evaluated overall response rate (primary end point) at the RP2D in patients with triple‐negative breast cancer (TNBC). During dose‐escalation (n = 24), two dose‐limiting toxicities (grade 4 lipase increased and grade 3 pyrexia) occurred in patients who received mivavotinib 80 mg and 100 mg, respectively. The determined RP2D was once‐daily mivavotinib 80 mg plus nivolumab 3 mg/kg. The expansion phase was terminated at ~50% enrollment (n = 17) after failing to meet an ad hoc efficacy futility threshold. Among all 41 patients, common treatment‐emergent adverse events (TEAEs) included dyspnea (48.8%), aspartate aminotransferase increased, and pyrexia (46.3% each). Common grade ≥3 TEAEs were hypophosphatemia and anemia (26.8% each). Mivavotinib plasma exposure was generally dose‐proportional (60–100 mg). One patient had a partial response. Mivavotinib 80 mg plus nivolumab 3 mg/kg was well tolerated with no new safety signals beyond those of single‐agent mivavotinib or nivolumab. Low response rates highlight the challenges of treating unresponsive tumor types, such as TNBC, with this combination and immunotherapies in general.

Trial registration ID:

NCT02834247.

01 Sep 2023·Pediatric blood & cancer

In vivo activity of the dual SYK/FLT3 inhibitor TAK‐659 against pediatric acute lymphoblastic leukemia xenografts

Article

Author: Bult, Carol J. ; Teicher, Beverly A. ; Stearns, Tim ; Evans, Kathryn ; Chuang, Jeffrey H. ; Lock, Richard B. ; Hughes, Keira ; Smith, Malcolm A. ; Earley, Eric J. ; Philip, Vivek M. ; Smith, Christopher M. ; Erickson, Stephen W. ; Jocoy, Emily L. ; Neuhauser, Steven B.

Abstract:

Background:

While children with acute lymphoblastic leukemia (ALL) experience close to a 90% likelihood of cure, the outcome for certain high‐risk pediatric ALL subtypes remains dismal. Spleen tyrosine kinase (SYK) is a prominent cytosolic nonreceptor tyrosine kinase in pediatric B‐lineage ALL (B‐ALL). Activating mutations or overexpression of Fms‐related receptor tyrosine kinase 3 (FLT3) are associated with poor outcome in hematological malignancies. TAK‐659 (mivavotinib) is a dual SYK/FLT3 reversible inhibitor, which has been clinically evaluated in several other hematological malignancies. Here, we investigate the in vivo efficacy of TAK‐659 against pediatric ALL patient‐derived xenografts (PDXs).

Methods:

SYK and FLT3 mRNA expression was quantified by RNA‐seq. PDX engraftment and drug responses in NSG mice were evaluated by enumerating the proportion of human CD45+ cells (%huCD45+) in the peripheral blood. TAK‐659 was administered per oral at 60 mg/kg daily for 21 days. Events were defined as %huCD45+ ≥ 25%. In addition, mice were humanely killed to assess leukemia infiltration in the spleen and bone marrow (BM). Drug efficacy was assessed by event‐free survival and stringent objective response measures.

Results:

FLT3 and SYK mRNA expression was significantly higher in B‐lineage compared with T‐lineage PDXs. TAK‐659 was well tolerated and significantly prolonged the time to event in six out of eight PDXs tested. However, only one PDX achieved an objective response. The minimum mean %huCD45+ was significantly reduced in five out of eight PDXs in TAK‐659‐treated mice compared with vehicle controls.

Conclusions:

TAK‐659 exhibited low to moderate single‐agent in vivo activity against pediatric ALL PDXs representative of diverse subtypes.

News (Medical) associated with Mivavotinib

14 Feb 2023

·www.biospace.com

Emergence Of SYK Inhibitors In Clinical Trials

The advent of immunotherapy has set a development foundation for modern cancer therapies, allowing emergence of novel modalities and targets shaping the future landscape for cancer treatment. A previously unidentified target, SYK is presenting as an interesting an attractive therapeutic target. Numerous studies are ongoing which have highlighted that SYK might be an important regulatory molecule involved in pathogenesis for several diseases. Therefore, the possibility of SYK inhibition is being actively explored as a therapeutic approach by the pharmaceutical industry. Download Report: Up until now, there is only one licensed SYK inhibitor drug available in the market, TAVALISSE that has produced clinical response in patients with immune thrombocytopenia (ITP) including those who are refractory to other treatments. Produced by Rigel Pharmaceuticals, the year 2022 observed growing sales for the drugs. During Q2 of 2022, TAVALISSE net product sales were US$18.6 Million, representing the highest net product sales since the launch an increase of 9% compared to the second quarter of 2021, as per Rigel’s quarterly report. For the third quarter of 2022, Rigel reported US$ 19.2 Million sales in TAVALISSE net product sales which increased by 20% compared to US$ 16.0 Million the third quarter of 2021, as per Rigel’s Quarterly Financial Report. Looking that commercial success of the only approved SYK inhibitor, the pharmaceutical industry aims to present more related treatment option for several other indications. This has encouraged numerous clinical research and development advancements to proceed in the area. Hutchmed Pharmaceuticals is testing their oral developed SYK inhibitor, Sovleplenib (HMPL-523). Currently, in its phase II/II clinical trials, the company is investigating the safety and preliminary efficacy of the drug in adult patients with warm antibody autoimmune hemolytic anemia. The phase III study aims to confirm the efficacy safety of HMPL-523, a novel, investigational, selective, small molecule inhibitor for oral administration targeting spleen tyrosine kinase (SYK). The pharmaceutical industry is always keeping up with the emerging and trending targets being identified by vigorous research and development all over the world. Therefore, it is surprising that the market is slowly shifting its focus on the emerging benefit of SYK inhibition. The topic has become attractive in the field and even though the underlying mechanism of SYK inhibitors has not been investigated in larger context. Kronos Bio Inc currently has two investigational spleen tyrosine kinase (SYK) inhibitors, Entospletinib and Lanraplenib in its clinical pipeline. The preclinical studies from both the drugs represent a promising future outcome and therefore, the company has started enrolling patients in the clinical study for each compound. Lanraplenib is being assessed in a Phase Ib/II study as a potential treatment for patients with relapsed/refractory acute myeloid leukemia in combination with Gilteritinib. Furthermore, Calithera Biosciences, a clinical stage precision oncology biopharmaceutical company is also investing a SYK inhibitor. The study has initiated patient enrollent in phase II trial evaluating Mivavotinib, a SYK inhibitoe in relapsed/refractory non-GCB diffuse large B-cell lymphoma (DLBCL). The data from the study is expected by the first quarter of 2023. The market landscape for SYK inhibitors looks flourishing with encouraging and robust clinical pipeline. The market however, still remains limited sixe as there is only one approved drug but with the positive promising results observed in clinical trials, it is not long that the market will see more approvals. With more drugs being in their advanced stages of development, the market for SYK inhibitors is expected to increase at a growing pace. There are several pharmaceuticals targeting this market segment; Alexion Pharmaceuticals, Aptose Biosciences, Archer Pharmaceuticals, Catithera Biosciences, Clevexel Pharma and many others.

Phase 2Phase 3ImmunotherapyPhase 1Clinical Result

10 Jan 2023

·www.fiercebiotech.com

Cash-strapped Calithera closes down in shadow of enrollment delays to cancer trials

"We truly wish the outcome was different today,” Calithera Biosciences CEO Susan Molineaux, Ph.D., said in a release. Calithera Biosciences has kept its head down since a phase 2 fail in 2021 caused layoffs for a third of its workforce. But in the wake of enrollment delays for two lead cancer therapies, the cash-strapped biotech has given up the fight and announced it’s liquidating the business. “The board of directors and management devoted substantial time and effort in identifying and pursuing various opportunities, but we were unable to complete a transaction that would allow us to continue the development of our clinical programs and enhance shareholder value,” CEO Susan Molineaux, Ph.D., said in a release Monday. As a result, all clinical programs will be shut down, with “most” of the company’s employees terminated by the end of this quarter. “Importantly, I would like to sincerely thank our employees and others who have supported Calithera over the years,” Molineaux added in her statement yesterday. “We appreciate your partnership and participation, and we truly wish the outcome was different today.” Money had been tight at the biotech for a while. Calithera had cash and equivalents of $34.1 million at the end of September, which was only expected to last into the second quarter of this year. In November, the company revealed it was “evaluating all options for its programs, including strategic collaboration or licensing agreements and actively considering the sale of certain programs, in order to extend its cash runway.” It can’t have helped that things weren’t quite going to plan for its lead programs, either. Calithera also used its November financial report to reveal that “site activation delays” meant that enrollment for trials of sapanisertib and mivavotinib had been “slower than anticipated.” Still, the company said at the time that initial data from these studies were expected in mid-2023, with sapanisertib having secured an FDA fast-track tag for non-small cell lung cancer in October. The biotech licensed both drugs from Takeda in 2021 after the failure of its own drug telaglenastat in a midstage kidney cancer test prompted Calithera to wield the ax on 35% of staff. Calithera's announcement is just the latest in a string of recent closures for struggling biotechs, with Otonomy winding down in December, followed by Nabriva Therapeutics last week.

Fast TrackFinancial Statement

14 Nov 2022

·www.globenewswire.com

Calithera Biosciences Reports Third Quarter 2022 Financial Results and Business Update

-- Conference Call and Webcast Scheduled for 5:00 p.m. ET on Monday, November 14, 2022 --SOUTH SAN FRANCISCO, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the third quarter ended September 30, 2022. “Earlier in the fourth quarter, we were very pleased to announce that we received FDA Fast Track designation for sapanisertib. This designation facilitates more frequent communication with the Agency, as well as a number of other benefits that could support our efforts to bring sapanisertib to patients in this area of high unmet need more quickly,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “Today we also share that we have experienced site activation delays on both our sapanisertib and mivavotinib trials, leading to slower than anticipated enrollment for both these programs. We expect initial data from these studies will not be available until mid-2023.” Third Quarter 2022 and Other Recent Highlights Received FDA Fast Track designation for sapanisertib (dual mTORC 1/2 inhibitor). In October, Calithera announced that sapanisertib has been granted Fast Track designation by the FDA for the treatment of adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors harbor the NRF2 mutation. Fast Track designation, which is designed to facilitate the development and expedite the review of therapeutic candidates with the potential to treat a serious or life-threatening condition where there is a major unmet medical need, provides a number of potential benefits including increased communication with the FDA, the ability to submit a marketing application on a rolling basis and the possibility of priority review. Began enrolling patients in Phase 2 trial evaluating sapanisertib in sqNSCLC. In July 2022, the Company began enrolling patients in its phase 2 clinical trial (NCT05275673) of the dual mTORC 1/2 inhibitor sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated sqNSCLC. The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to wild-type tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Calithera presented a trial-in-progress poster detailing the study design at the North American Conference on Lung Cancer in September 2022. Continued patient enrollment activities in Phase 2 trial evaluating mivavotinib (SYK inhibitor) in r/r non-GCB DLBCL. In June 2022, the Company began enrolling patients in its multicenter Phase 2 clinical trial (NCT05319028) evaluating mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL). The main objectives of the study are to confirm previously observed single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutation status and refine dose/schedule in this patient population. The primary endpoints of the study are overall response rate (as assessed by an independent radiology review committee) and safety. Details of the Phase 2 study design were presented in a trial-in-progress poster at the Pan Pacific Lymphoma Conference in July. Continued to advance VPS4 program through lead optimization. Calithera continued to advance multiple vacuolar protein sorting-associated protein 4A (VPS4A) and VPS4B inhibitors through lead optimization and plans to share updates on this program by the end of 2022. Selected Third Quarter 2022 Financial Results Cash and cash equivalents totaled $34.1 million at September 30, 2022. Based on its current operating plan, the Company expects it has sufficient cash to fund its operations into the second quarter of 2023. The Company is currently evaluating all options for its programs, including strategic collaboration or licensing agreements and actively considering the sale of certain programs, in order to extend its cash runway. Research and development expenses for the third quarter 2022 were $6.5 million, compared to $11.6 million in the same period prior year. The decrease of $5.1 million was primarily due to decreases in the telaglenastat and CB-280 programs and investments in early stage research, partially offset by increases in the sapanisertib and mivavotinib programs. General and administrative expenses for the third quarter 2022 were $3.0 million, compared to $6.3 million in the same period prior year. The decrease of $3.3 million was primarily due to decreased personnel-related costs and legal expenses. Net loss was $9.8 million for the three months ended September 30, 2022. Conference Call Information Calithera will host an update conference call today, Monday, November 14, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. To register for dial-in access to the call, please use this link. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days. About Calithera Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer, Calithera is advancing a robust pipeline of investigational, small-molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of Calithera’s product candidates, the overall advancement of Calithera’s product candidates in preclinical development and clinical trials, including the availability of initial data for the mivavotinib and sapanisertib trials by mid-2023, Calithera’s ability to potentially initiate registrational studies in biomarker-specific populations in DLBC and relapsed or refractory squamous NSCLC, the expectation that VPS4 inhibitors will be well-tolerated and have strong single-agent activity in tumors with certain mutations, Calithera’s plan to advance multiple VPS4 series through lead optimization and plan to share updates on this program by the end of the year, the unmet need in the treatment of patients with advanced disease, Calithera’s expectation that cash and cash equivalents will be sufficient to meet its current operating plan into the second quarter of 2023 and whether Calithera will be able to enter into strategic collaborations or licensing agreements or sell certain programs and sufficiently extend its cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances. Calithera Biosciences, Inc. Selected Consolidated Statements of Operations Financial Data(in thousands) (unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2022 2021 2022 2021Revenue: License revenue $— $6,750 $— $9,750 Total revenue — 6,750 — 9,750 Operating expenses: Research and development 6,447 11,556 23,771 39,715 General and administrative 3,079 6,344 10,957 16,259 Total operating expenses 9,526 17,900 34,728 55,974 Loss from operations (9,526) (11,150) (34,728) (46,224)Other income (expense): Transaction costs allocable to warrant liabilities — — (475) — Change in fair value of warrants liabilities (453) — 2,253 — Interest and other income (expense), net 177 (22) 236 346 Other income (expense), net (276) (22) 2,014 346 Net loss $(9,802) $(11,172) $(32,714) $(45,878) Calithera Biosciences, Inc. Selected Consolidated Balance Sheet Financial Data (in thousands) (unaudited) September 30, December 31, 2022 2021Balance Sheet Data: Cash and cash equivalents$34,068 $59,537 Working capital 25,465 47,446 Total assets 37,083 64,756 Total liabilities 10,695 15,672 Convertible preferred stock 22,342 40,702 Accumulated deficit (505,680) (491,326)Total stockholders’ equity 26,388 8,382 CONTACTS:Stephanie Wong ir@Calithera.com 650.870.1063 INVESTORS:Burns McClellanLee Roth212.213.0006lroth@burnsmc.com MEDIA:Sam Brown, Inc.Hannah Hurdle805.338.4752hannahhurdle@sambrown.com

Phase 2Financial StatementFast TrackPhase 1

100 Deals associated with Mivavotinib

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 2	US	Calithera Biosciences, Inc.	23 Jun 2022
Relapsing acute myeloid leukemia	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	20 Sep 2019
Diffuse large B-cell lymphoma recurrent	Phase 2	US	Calithera Biosciences, Inc.	10 Oct 2017
Diffuse large B-cell lymphoma recurrent	Phase 2	CA	Calithera Biosciences, Inc.	10 Oct 2017
Diffuse large B-cell lymphoma recurrent	Phase 2	FR	Calithera Biosciences, Inc.	10 Oct 2017
Diffuse large B-cell lymphoma recurrent	Phase 2	IT	Calithera Biosciences, Inc.	10 Oct 2017
Diffuse large B-cell lymphoma recurrent	Phase 2	ES	Calithera Biosciences, Inc.	10 Oct 2017
Diffuse large B-cell lymphoma recurrent	Phase 2	GB	Calithera Biosciences, Inc.	10 Oct 2017
Refractory acute myeloid leukemia	Phase 2	US	Calithera Biosciences, Inc.	09 Mar 2015
Refractory acute myeloid leukemia	Phase 2	CA	Calithera Biosciences, Inc.	09 Mar 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03742258 (CTgov)	Phase 1	High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements \| T-cell/histiocyte rich large B-cell lymphoma	12	Spleen Tyrosine Kinase Inhibitor+Cyclophosphamide+Prednisone+doxorubicin hydrochloride+Rituximab+Vincristine Sulfate+TAK-659 (TAK-659 60mg + R-CHOP)	pakbxmxlhq(ikwkrmbqcl) = pktgwuwdix iuuraglwak (gfgmsyrfye, vzfddooexp - mnmvtopwcu) View more	-	29 Jan 2025
				Doxorubicin Hydrochloride+Spleen Tyrosine Kinase Inhibitor+Cyclophosphamide+Prednisone+Rituximab+Vincristine Sulfate+TAK-659 (TAK-659 80mg + R-CHOP)	pakbxmxlhq(ikwkrmbqcl) = gfkdgkpmrk iuuraglwak (gfgmsyrfye, vktrafkopo - nzegiipxeb) View more
NCT02000934 (Pubmed)	Phase 1	B-Cell Lymphoma \| Diffuse Large B-Cell Lymphoma	124	Mivavotinib 60-120 mg	wmudetdsdi(wnfpkjqlhx) = pzpvnybxzq abaelaprjk (wpqhxhcvim ) View more	-	26 Jan 2023
NCT02323113 (Pubmed \| Haematologica) Manual	Phase 1	Relapsing acute myeloid leukemia	43	TAK-659 QD	eucinmdhfb(qctqdnnhon) = 140 mg QD pulxvlhpmq (xauwcrmppx ) View more	Positive	13 Oct 2022
				TAK-659 BID
NCT03238651 (CTgov)	Phase 1	Marginal Zone B-Cell Lymphoma	17	TAK-659 (Dose Escalation Part, Schedule Dosing A: TAK-659 40 mg)	xapezpzjmz(fyfhqagisk) = zwhxgeaots wlprskujlq (pbprortbno, xnyvaqbbat - vcxgfdxpnd) View more	-	14 Sep 2021
				TAK-659 (Dose Escalation Part, Dosing Schedule A: TAK-659 60 mg)	xapezpzjmz(fyfhqagisk) = yvwfjpivjp wlprskujlq (pbprortbno, qldtabqxoz - hojrwuwayf) View more
NCT03123393 (CTgov)	Phase 2	Diffuse large B-cell lymphoma recurrent	49	TAK-659 (Cohort A: TAK-659 100 mg)	opqqxggnth(xevuwkxogw) = eldmtttefp nkfmrjrfng (gumwnqluus, pqvshqwcob - lnmlvoupnb) View more	-	16 Sep 2020
				TAK-659 (Cohort B: TAK-659 Ramp-up Dosing)	opqqxggnth(xevuwkxogw) = etpvdcbtaf nkfmrjrfng (gumwnqluus, uguhtyhwqi - zrgmmaqdrq) View more
NCT02000934 (Pubmed \| Clin Cancer Res) Manual	Phase 1	B-Cell Lymphoma	105	TAK-659	pflfjlxhai(sxylfyukxo) = ufsjegvmvp fkhiuxlakc (kmwrcccnki ) View more	Positive	15 Jul 2020
NCT02834247 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm \| Squamous Cell Carcinoma of Head and Neck \| Triple Negative Breast Cancer ... View more	41	nivolumab+TAK-659 (Part 1: Dose Escalation Participants)	aunbkjtoxd(unahytiafq) = cvowjrfncz kdsnxivizy (rodejquava, limbmziinq - xqlheauptw) View more	-	31 Mar 2020
				Nivolumab+TAK-659 (Part 2: TAK-659 80 mg + Nivolumab 3 mg/kg (TNBC))	brmrvdotlh(bkopatxcrs) = pviowmqrbs qbehgqaheb (tifloxmsac, ezyvkvbkdj - kmbalvmcns) View more
NCT03123393 (ASH 12019 \| ASH 22019) Manual	Phase 2	Diffuse large B-cell lymphoma recurrent Third line	49	Mivavotinib	ontnqymwmy(egrmuawqir) = qokpehdsrh zwainqeiok (nyrnvgvjwh ) View more	Negative	13 Nov 2019
NCT02834247 (ASCO 12018 \| ASCO 22018) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	19	TAK-659+Nivolumab	bapamsdzns(yilnpvlsln) = TAK-659 100 mg + nivo exceeded the MTD lhpvbqfapg (vijqmovmsg ) View more	Positive	01 Jun 2018
NCT02323113 (ASCO2016)	Phase 1/2	Acute Myeloid Leukemia	43	TAK-659	znwbwlpmqi(nqolksuncf) = owrcyscoao vnwvxmmivp (dvwclnuwll ) View more	Positive	20 May 2016

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