Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma

The main goal of this study is to test if it is safe and effective to give CDX-3379 together to treat advanced melanoma in patients with the NRAS mutation and BRAF/NRAS wildtype.

Start Date06 Jul 2018

Sponsor / Collaborator

NYU Langone Health

[+1]

NCT02473731

/ CompletedPhase 1

A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck cancer patients and to explore downstream molecular pathways to identify tumor response and resistance mechanisms by evaluating various biomarkers before and after treatment.

Start Date01 Oct 2015

Sponsor / Collaborator

Celldex Therapeutics, Inc.

NCT02456701

/ CompletedPhase 1

Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI Refractory Thyroid Cancers With the Combination of BRAF Inhibitor Vemurafenib and Anti-ErbB3 Antibody KTN3379: A Pilot Study With a Phase 1 Run-in

This is a patient pilot study testing the hypothesis that vemurafenib with the addition of KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR) thyroid cancer patients.

Start Date01 Jun 2015

Sponsor / Collaborator

Celldex Therapeutics, Inc.

[+1]

100 Clinical Results associated with KTN-3379

100 Translational Medicine associated with KTN-3379

100 Patents (Medical) associated with KTN-3379

Literatures (Medical) associated with KTN-3379

01 Mar 2022·Thyroid : official journal of the American Thyroid AssociationQ1 · MEDICINE

Enhancing Radioiodine Incorporation in BRAF-Mutant, Radioiodine-Refractory Thyroid Cancers with Vemurafenib and the Anti-ErbB3 Monoclonal Antibody CDX-3379: Results of a Pilot Clinical Trial

Q1 · MEDICINE

Article

Author: Seshan, Venkatraman E. ; Pentlow, Keith S. ; Ho, Alan L. ; Haque, Sofia ; Baxi, Shrujal S. ; Grewal, Ravinder K. ; Tchekmedyian, Vatche ; Pfister, David G. ; Dunn, Lara ; Fagin, James A. ; Fish, Stephanie ; Walters, Jamie ; Sherman, Eric ; Knauf, Jeffrey A. ; Ghossein, Ronald A. ; Sabra, Mona M. ; Tuttle, R. Michael ; Larson, Steven M. ; Boucai, Laura

Background: Oncogenic activation of mitogen-activated protein kinase (MAPK) signaling is associated with radioiodine refractory (RAIR) thyroid cancer. Preclinical models suggest that activation of the receptor tyrosine kinase erbB-3 (HER3) mitigates the MAPK pathway inhibition achieved by BRAF inhibitors in BRAF^V600E mutant thyroid cancers. We hypothesized that combined inhibition of BRAF and HER3 using vemurafenib and the human monoclonal antibody CDX-3379, respectively, would potently inhibit MAPK activation and restore radioactive iodine (RAI) avidity in patients with BRAF-mutant RAIR thyroid cancer. Methods: Patients with BRAF^V600E RAIR thyroid cancer were evaluated by thyrogen-stimulated iodine-124 (¹²⁴I) positron emission tomography-computed tomography (PET/CT) at baseline and after 5 weeks of treatment with oral vemurafenib 960 mg twice daily alone for 1 week, followed by vemurafenib in combination with 1000 mg of intravenous CDX-3379 every 2 weeks. Patients with adequate ¹²⁴I uptake on the second PET/CT then received therapeutic radioactive iodine (¹³¹I) with vemurafenb+CDX-3379. All therapy was discontinued two days later. Treatment response was monitored by serum thyroglobulin measurements and imaging. The primary endpoints were safety and tolerability of vemurafenib+CDX-3379, as well as the proportion of patients after vemurafenb+CDX-3379 therapy with enhanced RAI incorporation warranting therapeutic ¹³¹I. Results: Seven patients were enrolled; six were evaluable for the primary endpoints. No grade 3 or 4 toxicities related to CDX-3379 were observed. Five patients had increased RAI uptake after treatment; in 4 patients this increased uptake warranted therapeutic ¹³¹I. At 6 months, 2 patients achieved partial response after ¹³¹I and 2 progression of disease. Next-generation sequencing of 5 patients showed that all had co-occurring telomerase reverse transcriptase promoter alterations. A deleterious mutation in the SWItch/Sucrose Non-Fermentable (SWI/SNF) gene ARID2 was discovered in the patient without enhanced RAI avidity after therapy and an RAI-resistant tumor from another patient that was sampled off-study. Conclusions: The endpoints for success were met, providing preliminary evidence of vemurafenib+CDX-3379 safety and efficacy for enhancing RAI uptake. Preclinical data and genomic profiling in this small cohort suggest SWI/SNF gene mutations should be investigated as potential markers of resistance to redifferentiation strategies. Further evaluation of vemurafenib+CDX-3379 as a redifferentiation therapy in a larger trial is warranted (ClinicalTrials.gov: NCT02456701).

01 Nov 2019·Molecular cancer therapeuticsQ2 · MEDICINE

Neuregulin Signaling Is a Mechanism of Therapeutic Resistance in Head and Neck Squamous Cell Carcinoma

Q2 · MEDICINE

Article

Author: Lemmon, Mark A. ; Baro, Marta ; Contessa, Joseph N. ; Lopez Sambrooks, Cecilia ; Burtness, Barbara A.

Abstract:

EGFR signaling confers resistance to radiotherapy and is a validated target in head and neck squamous cell carcinoma (HNSCC). The inhibition of EGFR in combination with radiotherapy improves local control and overall survival in these patients; however, therapeutic resistance limits the efficacy of this approach. We therefore sought to identify cellular mechanisms that cause resistance to EGFR inhibition and radiotherapy in HNSCC. Though clonal isolation of carcinoma cells exposed to increasing concentrations of cetuximab, we found that resistant cells upregulate prosurvival ErbB3 and AKT signaling. Using EFM-19 cells and confirmatory analysis of protein levels, we demonstrate that cetuximab resistance is characterized by enhanced neuregulin expression identifying a novel adaptive mechanism of therapeutic resistance. Inhibition of this autocrine loop with CDX-3379 (an ErbB3 specific antibody) was sufficient to block ErbB3/AKT signaling in cetuximab resistant cells. The combination of CDX-3379 and cetuximab reduced proliferation and survival after radiotherapy in several HNSCC cell lines. These in vitro findings were confirmed in xenograft tumor growth experiments including an approach using growth factor–supplemented Matrigel. In vivo, the delivery of EGFR and ErbB3 antibodies significantly reduced tumor growth in cetuximab-resistant FaDu and CAL27 xenografts. In summary, this work demonstrates that autocrine NRG ligand secretion is a mechanism for therapeutic resistance to cetuximab and radiotherapy. This cross-resistance to both therapeutic modalities identifies NRG as an actionable therapeutic target for improving treatment regimens in HNSCC.

01 Oct 2019·Clinical cancer research : an official journal of the American Association for Cancer Research

Molecular and Clinical Activity of CDX-3379, an Anti-ErbB3 Monoclonal Antibody, in Head and Neck Squamous Cell Carcinoma Patients

Article

Author: Neumeister, Veronique M. ; Bauman, Julie E. ; Alvarado, Diego ; Duvvuri, Umamaheswar ; Chenna, Ahmed ; Kim, Seungwon ; Gedrich, Richard ; Grandis, Jennifer R. ; Hawthorne, Thomas ; George, Jonathan ; LaVallee, Theresa

Abstract:

Purpose::

ErbB3 and its ligand neuregulin-1 (NRG1) are widely expressed in head and neck squamous cell carcinoma (HNSCC) and associated with tumor progression. A “window-of-opportunity” study (NCT02473731) was conducted to evaluate the pharmacodynamic effects of CDX-3379, an anti-ErbB3 mAb, in patients with HNSCC.

Patients and Methods::

Twelve patients with newly diagnosed, operable HNSCC received two infusions of CDX-3379 (1,000 mg) at a 2-week interval prior to tumor resection. The primary study objective was to achieve ≥50% reduction in tumor ErbB3 signaling (phosphorylation of ErbB3; pErbB3) in ≥30% of patients. Other potential tumor biomarkers, pharmacokinetics, safety, and tumor measurements were also assessed.

Results::

pErbB3 was detectable in all tumors prior to treatment and decreased for 10 of 12 (83%) patients following CDX-3379 dosing, with ≥50% reduction in 7 of 12 (58%; P = 0.04; 95% confidence interval, 27.7%–84.8%). Target trough CDX-3379 serum levels were achieved in all patients. CDX-3379 treatment–related toxicity was grade 1–2 and included diarrhea, fatigue, and acneiform dermatitis. Five of 12 (42%) patients had shrinkage in tumor burden, including a marked clinical response in a patient with human papillomavirus–negative oral cavity HNSCC. All patients with tumor shrinkage had tumors that expressed both NRG1 and ErbB3 and demonstrated reduced pErbB3 with CDX-3379 treatment.

Conclusions::

This study demonstrates that CDX-3379 can inhibit tumor ErbB3 phosphorylation in HNSCC. CDX-3379 was well tolerated and associated with measurable tumor regression. A phase II study (NCT03254927) has been initiated to evaluate CDX-3379 in combination with cetuximab for patients with advanced HNSCC.

News (Medical) associated with KTN-3379

05 Aug 2021

·www.globenewswire.com

Celldex Reports Second Quarter 2021 Financial Results and

- Positive data from CDX-0159 Phase 1b Study in Chronic Inducible Urticaria presented at EAACI 2021 - - Raised $287 million in gross proceeds from a follow-on public offering of common stock, closed in July 2021 - HAMPTON, N.J., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update. “Last month, Celldex reported positive data from our ongoing Phase 1b study of CDX-0159 in chronic inducible urticaria, where a single dose demonstrated a rapid, profound and durable response,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “These data not only spoke to the potential to bring patients suffering from urticaria an opportunity for fast, lasting and meaningful relief, but also showed that CDX-0159 safely depletes mast cells, a significant scientific and medical achievement that indicates CDX-0159’s potential to help other patients in need across a myriad of diseases with mast cell involvement.” Mr. Marucci continued, “Importantly, driven by these data, we successfully completed a $287.5 million follow-on offering which will support the expansion of the CDX-0159 program into later stage studies and additional indications, along with the continued development of our bispecific platform, which is exploring important pathways in inflammatory diseases, auto-immune disorders and oncology. We look forward to building on our successes in what promises to be an exciting second half of the year.” Recent Program Highlights CDX-0159 - KIT Inhibitor Program CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. CDX-1140 - CD40 Agonist Program CDX-1140 is a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile. CDX-527 - Bispecific Antibody Program CDX-527 is the first candidate developed by Celldex from its bispecific platform and utilizes the Company’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. Corporate Highlights While Celldex’s clinical development programs have not been significantly, negatively impacted by COVID-19 to date, the Company continues to carefully monitor the evolving situation closely across all development programs and work to minimize potential impact/disruptions. Second Quarter 2021 Financial Highlights and 2021 Guidance Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $164.0 million compared to $176.1 million as of March 31, 2021. The decrease was primarily driven by second quarter cash used in operating activities of $11.9 million. At June 30, 2021, Celldex had 39.6 million shares outstanding. In July 2021, the Company issued 6,845,238 shares of its common stock in an underwritten public offering of common stock resulting in net proceeds to the Company of approximately $270.0 million, after deducting underwriting fees and offering expenses. Revenues: Total revenue was $3.5 million in the second quarter of 2021 and $4.2 million for the six months ended June 30, 2021, compared to $0.2 million and $3.0 for the comparable periods in 2020. The increase in revenue was primarily due to an increase in services performed under our contract manufacturing and research and development agreements with Rockefeller University and Gilead Sciences, partially offset by a decrease in revenue from product development and licensing agreements as a result of the $1.8 million milestone payment received from Rockefeller University in the first quarter of 2020 related to Celldex’s manufacturing and development services agreement. R&D Expenses: Research and development (R&D) expenses were $12.4 million in the second quarter of 2021 and $25.1 million for the six months ended June 30, 2021, compared to $9.7 million and $21.4 million for the comparable periods in 2020. The increase in R&D expenses was primarily due to an increase in clinical trial, contract research, and personnel expenses, partially offset by a decrease in rent expense. G&A Expenses: General and administrative (G&A) expenses were $4.3 million in the second quarter of 2021 and $8.4 million for the six months ended June 30, 2021, compared to $3.5 million and $7.2 million for the comparable periods in 2020. The increase in G&A expenses was primarily due to higher personnel expenses. Intangible Asset Impairment: The Company recorded a non-cash impairment charge of $3.5 million during the second quarter of 2020 due to the discontinuation of the CDX-3379 program. Changes in Fair Value Remeasurement of Contingent Consideration: The loss on fair value remeasurement of contingent consideration was $0.3 million for the second quarter of 2021 and $0.7 million for the six months ended June 30, 2021, primarily due to changes in discount rates and the passage of time. Net Loss: Net loss was $13.4 million, or ($0.34) per share, for the second quarter of 2021, and $29.9 million, or ($0.76) per share, for the six months ended June 30, 2021, compared to a net loss of $11.0 million, or ($0.50) per share, for the second quarter of 2020 and $23.7 million, or ($1.20) per share, for the six months ended June 30, 2020. Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2021, along with the approximately $270.0 million in net proceeds raised in our July 2021 underwritten public offering of common stock, are sufficient to meet estimated working capital requirements and fund planned operations through 2025. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA. About Celldex Therapeutics, Inc.Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. Visit . Forward Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including CDX-0159, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the effects of the outbreak of COVID-19 on our business and results of operations; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company ContactSarah CavanaughSenior Vice President, Corporate Affairs & Administration(508) 864-8337scavanaugh@celldex.com Patrick TillSenior Director, Investor Relations & Corporate Communications(484) 788-8560ptill@celldex.com

CollaborateFinancial StatementAntibody

08 Nov 2016

·www.biospace.com

Little Celldex is Sitting on Plenty of Cash and is Ready to Go Shopping

November 8, 2016 By Mark Terry , BioSpace.com Breaking News Staff Hampton, NJ-based Celldex announced recently that it planned to acquire Kolltan Pharmaceuticals . In addition to the news from its third-quarter financial report, the company indicated it had $203.2 million in cash, cash equivalents and marketable securities at the end of the third quarter. Is this a hint the company will do more acquisitions? Maybe. But the real focus appears to be on its pipeline. The Kolltan acquisition is a stock-for-stock deal with an upfront equity value of about $62.5 million. What’s most interesting is the pipeline products it picked up in the deal. KTN-158 is a humanized monoclonal antibody that inhibits KIT activation and receptor dimerization in tumor cells and mast cells. It’s currently in a Phase I study in refractory gastrointestinal stromal tumors (GIST). KTN3379 is a monoclonal antibody that blocks the activity of ErbB3 (HER3). It just finished a Phase Ib trial with combination cohorts in cetuximab (Erbitux) refractory patients in head and neck squamous cell carcinoma and in BRAF-mutant non-small cell lung cancer (NSCLC). It also picked up a multi-faceted TAM program, which it describes as “a broad antibody discovery effort underway to generate antibodies that modulate the TAM family of RTKs, comprised of Tyro3, AXL and MerTK, which are expressed on tumor-infiltrating macrophages, dendritic cells and some tumors.” It’s believed to have broad potential in immuno-oncology and inflammatory diseases. Keith Speights, writing for The Motley Fool, says, “The Kolltan acquisition adds a new twist for investors to watch. However, the main catalysts for Celldex should continue to be clinical results for glemba and varlilumab. How the biotech’s stock performs will depend primarily on its pipeline progress.” In a statement, Anthony Marcucci, Celldex’s co-founder, president and chief executive officer, said, “In the third quarter, we presented important data from our Phase II study of glembatumumab vedotin in checkpoint-refractory metastatic melanoma at ESMO, meeting the primary overall response endpoint and demonstrating clinically meaningful duration of response in this difficult-to-treat setting. Building on these promising signals, we are now enrolling a combination arm with our CD27 agonist, varlilumab, and are in the process of finalizing an additional arm to explore a glembatumumab vedotin and checkpoint inhibitor combination.” Likely of even more interest is that the company continues to enroll patients in a Phase IIb trial of glemba in metastatic triple-negative breast cancer. Celldex hopes that the results of the trial will give it enough positive data to regulatory approval. The company also has an ongoing Phase II trial of varlilumab with Bristol-Myers Squibb (BMS)’s Opdivo for several different types of cancer. It’s also studying varlilumab in combination with glemba in a Phase II trial for metastatic melanoma. Speights writes, “Investigator-sponsored trials are in progress for a couple of other pipeline candidates. The National Cancer Institute is sponsoring a Phase II study of CDX-1401 and CDX-301. Roswell Park Cancer Center is conducting an early stage study of CDX-1401 in combination with Hiltonol and epacadostat targeting treatment of patients in remission with ovarian, fallopian tube, or primary peritoneal cancer.” Although the company is staying mum about more acquisitions, it has hinted that it might make a secondary offering of public stock. is currently trading for $3.47.

Phase 2Phase 1Clinical ResultAcquisitionImmunotherapy

02 Nov 2016

·www.biospace.com

Celldex Takes Out Kolltan Pharma in $235 Million Deal

November 2, 2016 By Alex Keown , BioSpace.com Breaking News Staff HAMPTON, N.J. – Celldex Therapeutics, Inc. snapped up privately held Kolltan Pharmaceuticals, Inc. in a $235 million deal that is expected to expand its oncology pipeline with potential drugs that can be combined with its existing therapies. The deal is an attempt by Celldex to bounce back following the March failure of the company’s cancer vaccine Rintega. The company ultimately terminated its research on Rintega, which had at one time earned Breakthrough Therapy Designation by the FDA for treatment of glioblastoma. Celldex said Kolltan has reported clinical and preclinical data that its drug candidates can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies. As a result, Celldex said it believes Kolltan’s drugs can be developed independently and in combination with Celldex’s existing product candidates. “The acquisition of Kolltan provides Celldex with a truly unique platform of antibodies targeting receptor tyrosine kinases which we believe are highly compatible with our pipeline. We believe this acquisition complements our leadership position in immuno-oncology and enhances our ability to develop targeted therapeutic regimens to dramatically improve patient outcomes,” Anthony Marucci , president and chief executive officer of Celldex Therapeutics, said in a statement. Gerald McMahon , CEO of Kolltan Pharmaceuticals, said in a statement that Celldex is “uniquely positioned to advance our antibody portfolio targeting RTKs to improve outcomes for patients and create optimal value for our shareholders.” Kolltan’s portfolio includes three drugs that Celldex believes have potential. The drugs include the Phase I drug KTN0158, a humanized monoclonal antibody targeting refractory gastrointestinal stromal tumors. KTN0158 prevents KIT activation by blocking receptor dimerization. This mechanism may be effective even in tumors harboring the most common resistant mutations to Novartis ’ Gleevec and is unlikely to drive resistance, Celldex said. Another experimental drug that Celldex noted is the Phase Ib therapy KTN3379, a human monoclonal antibody designed to block the activity of ErbB3 (HER3). KTN3379 also has potential to work well in combination with other targeted and cytotoxic therapies to directly kill tumor cells, Celldex said in a statement. Celldex has a promising treatment for triple negative breast cancer. Glembatumumab vedotin is a protein that binds to gpNMB, a protein found on the surface of tumors. The third piece of the pipeline is a multi-faceted TAM program—a broad antibody discovery effort underway to generate antibodies that modulate the TAM family of RTKs, comprised of Tyro3, AXL and MerTK, which are expressed on tumor-infiltrating macrophages, dendritic cells and some tumors. Under terms of the deal, Celldex will acquire Kolltan in a stock-for-stock transaction, including an upfront stock payment of $62.5 million. Kolltan shareholders are eligible to receive additional payments of up to $172.5 million upon the completion of specific development, regulatory and commercial milestones. Shares of Celldex are up more than 1 percent this morning, trading at $3.16 as of 11:20 a.m.

VaccinePhase 1AcquisitionImmunotherapyBreakthrough Therapy

100 Deals associated with KTN-3379

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
NRAS Mutant Melanoma	Phase 2	United States	Celldex Therapeutics, Inc.	06 Jul 2018
Breast Cancer	Phase 2	United States	Celldex Therapeutics, Inc.	27 Mar 2018
Head and Neck Neoplasms	Phase 2	United States	Celldex Therapeutics, Inc.	-
Head and Neck Neoplasms	Phase 2	-	MedImmune LLC	-
Squamous Cell Carcinoma of Head and Neck	Phase 1	United States	Celldex Therapeutics, Inc.	01 Oct 2015
Thyroid Cancer with BRAF mutation	Phase 1	United States	Celldex Therapeutics, Inc.	01 Jun 2015
Advanced cancer	Phase 1	United States	Celldex Therapeutics, Inc.	01 Jan 2014
Thyroid Cancer	Phase 1	-	MedImmune LLC	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02473731 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck First line	12	CDX-3379	jqpjeczzfb(rlfxbdopij) = vrfabjjnxg lslbmlbdlx (gvvseokthv, 27.7 - 84.8) View more	Positive	01 Oct 2019
AACR2018	Phase 1	Squamous Cell Carcinoma of Head and Neck	12	CDX-3379	kipeckzexi(osxajosdho) = dejgtejjkn pjhxmpenoe (qnsdploipo )	-	01 Jul 2018
NCT02014909 (ASCO 12016 \| ASCO 22016) Manual	Phase 1	Neoplasms	58	cetuximab+erlotinib+vemurafenib+trastuzumab+KTN3379	wwaqrfnqzz(atjqmvryly) = No DLTs occurred in 21 pts. DLTs of diarrhea, mucositis and rash were observed in 5 of 37 pts treated with combinations. nvygxnoirw (wwoqblkuiy ) View more	Positive	06 Jun 2016

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