Delving into the Latest Updates on Xevinapant with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Iap inhibitor at-406, SMAC mimetic, AT 406

+ [3]

Target

IAP x XIAP x cIAP1 x cIAP1/cIAP2

Mechanism

Inhibitors of apoptosis (IAP) protein family inhibitors, XIAP inhibitors(Inhibitor of apoptosis protein 3 inhibitors), cIAP1 inhibitors(Cellular inhibitor of apoptosis protein 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesEndocrinology and Metabolic Disease+ [6]

Active Indication

Squamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsCutaneous Squamous Cell Carcinoma of the Head and Neck+ [8]

Inactive Indication

Acute Myeloid LeukemiaAdvanced Malignant Solid NeoplasmColonic Cancer+ [6]

Originator Organization

ASCENTA

Active Organization

EMD Serono Research & Development Institute, Inc.Merck KGaAASCENTA

+ [4]

Inactive Organization

Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

Ascenta Therapeutics, Inc.Farmea

+ [3]

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (US)

Structure

Molecular FormulaC32H44ClN5O4

InChIKeyDBXTZCYPHKJCHF-ZZPLZQMBSA-N

CAS Registry1071992-57-8

Researchers will investigate the ability of Xevinapant to cross the blood-brain barrier and exert anti-tumor effects on rHGG through activation of apoptosis. Researchers hypothesize that oral administration of Xevinapant has acceptable safety and tolerability in patients with recurrent HGG and demonstrate pharmacokinetic and pharmacodynamic effects in HGG tumors. To that end, Researchers will engage in a phase I "window of opportunity" translational clinical trial in patients undergoing a clinically-indicated craniotomy for resection of recurrent tumors to evaluate the impact of treatment on rHGG.

Start Date01 Jun 2024

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

NCT06084845 / Not yet recruitingPhase 2

Phase II Trial of Xevinapant and Chemoradiotherapy in Adjuvant Treatment for Patients With Head and Neck Squamous Cell Carcinoma With High Risk Pathologic Features

This phase II trial compares the effect of usual radiation therapy with cisplatin/carboplatin (chemoradiation) to the addition of xevinapant with chemoradiation in patients with head and neck cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Xevinapant is a first-in-class antagonist of inhibitor of apoptosis (programmed cell death) proteins (IAPs), which leads to tumor cell death and enhances tumor cell sensitivity to chemotherapy and radiotherapy. Giving xevinapant with chemoradiation may be more effective in preventing head and neck cancer from growing or spreading than chemoradiation alone.

Start Date12 Apr 2024

Sponsor / Collaborator

ECOG-ACRIN Medical Research Foundation, Inc.

[+1]

NCT06110195 / Active, not recruitingPhase 1IIT

A Phase I Study of Xevinapant With Radiation and Concurrent Carboplatin and Paclitaxel in Patients Ineligible for Cisplatin With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

The goal of this clinical trial is to determine the best safe dose of xevinapant that can be given in combination with chemotherapy and radiation in patients with head and neck cancer. Up to 4 doses of xevinapant will be tested in the dose escalation portion of the study. After the best safe dose is found during escalation, an additional group of participants will be enrolled at that dose to learn more about the treatment combination (dose expansion).
The main question[s] it aims to answer are:
what is the maximum safe dose that can be given
what dose should be used in subsequent (phase 2) trials
Participants will receive xevinapant in combination with paclitaxel and carboplatin chemotherapy and radiation. Treatment will be given in 3-week cycles for 3 cycles.

Start Date24 Jan 2024

Sponsor / Collaborator

The University of Chicago

[+1]

100 Clinical Results associated with Xevinapant

Login to view more data

100 Translational Medicine associated with Xevinapant

Login to view more data

100 Patents (Medical) associated with Xevinapant

Login to view more data

387

Literatures (Medical) associated with Xevinapant

05 Jul 2106·Oncotarget

Inhibitor of Apoptosis Proteins (IAPs) are commonly dysregulated in GIST and can be pharmacologically targeted to enhance the pro-apoptotic activity of imatinib

Article

Author: Heinrich, Michael ; Corless, Christopher ; Bauer, Sebastian ; Marino-Enriquez, Adrian ; Reis, Anna-Carina ; Podleska, Lars Erik ; Mühlenberg, Thomas ; Fletcher, Jonathan Alfred ; Treckmann, Jürgen ; Grunewald, Susanne ; Falkenhorst, Johanna ; Schuler, Martin

Gastrointestinal stromal tumors (GIST) exhibit a strong oncogenic dependency on KIT and KIT inhibitors confer long lasting disease stabilization in the majority of patients. Nonetheless, KIT inhibition alone does not cure GIST as a subset of GIST cells evade apoptosis and eventually develop resistance. Inhibitors of Apoptosis Proteins (IAPs) may confer resistance to drug-induced apoptosis. We observed that the mRNA and protein of IAPs XIAP (BIRC4) and survivin (BIRC5) were highly expressed in primary GIST tumors and cell line models. Amplification of the respective gene loci (BIRC2, BIRC3, BIRC4, BIRC5) was detected in 47% of GIST studied by SNP arrays. Whole exome analyses revealed a mutation of SMAC(DIABLO) in a heavily pretreated patient. Both, survivin (rank 62-92/11.194 tested proteins) and XIAP (rank 106-557/11.194) were found to be essential proteins for survival in a synthetic lethality screen. Expression of XIAP and survivin decreased upon KIT inhibition and may play a role in KIT-regulated pro-survival signaling. SMAC-mimetic treatment with LCL161 and TL32711 reduced cIAP1 and XIAP expression. Survivin inhibitor YM155 lead to transcriptional repression of BIRC5/survivin (YM155) and induced apoptosis. Combinational treatment with KIT inhibitors (imatinib, regorafenib) enhanced the proapoptotic effect. These findings support the combination of KIT inhibition with IAP antagonists in GIST.

01 Feb 2024·Molecular metabolism

Sestrin2 maintains hepatic immune homeostasis and redox balance partially via inhibiting RIPK3-mediated necroptosis in metabolic dysfunction-associated steatohepatitis

Article

Author: Lin, Shuang-Zhe ; Zhang, Qian-Ren ; Fan, Jian-Gao ; Jin, Qian ; Zhang, Jian-Bin ; Yang, Jing

BACKGROUND & AIMS:

Necroptosis, a novel type of programmed cell death, is intricately associated with inflammatory response. Currently, most studies focus on the activation of necroptosis, while the mechanisms underlying the negative regulation of necroptosis remain poorly understood.

METHODS:

The effects of sestrin2 (SESN2) overexpression or knockdown on the regulation of necroptosis were assessed in the TNFα/Smac-mimetic/Z-VAD-FMK (T/S/Z)-induced necroptosis model and palmitic acid (PA)-induced lipotoxicity model. Western-blot, co-Immunoprecipitation, Glutathione S-transferase pull-down, and confocal assays were employed to explore the regulatory mechanisms including protein-protein interactions and post-translational modification. Furthermore, we used GSK'872, a specific inhibitor of receptor-interacting serine/threonine-protein kinase (RIPK) 3, to evaluate the relationship between SESN2-related alterations and RIPK3-mediated necroptosis in T/S/Z-induced necroptosis model, PA-induced lipotoxicity model, and high-fat high-cholesterol diet (HFHCD)-induced non-alcoholic steatohepatitis model.

RESULTS:

Our findings revealed that SESN2 was upregulated under conditions that induce necroptosis and functioned as a negative regulator of necroptosis. High levels of SESN2 could equipped hepatocytes with the ability to defend against necroptotic inflammation and oxidative stress. Mechanistically, SESN2 interacted with RIPK3 and tuned down necroptosis by inhibiting the phosphorylation of RIPK3, promoting the ubiquitination of RIPK3, and preventing the formation of the RIPK1/RIPK3 necrosome. The depletion of SESN2 resulted in excessive necroptosis, accompanied by increased fat accumulation, inflammation, and oxidative stress in the experimental steatohepatitis model. Blocking necroptosis by GSK'872 reduced the liberation of pro-inflammatory cytokines and reactive oxygen species generation, but not hepatocyte fat deposition, in both PA-treated SESN2 knockout cells and HFHCD-fed SESN2 knockout mice, suggesting that the activation of RIPK3-mediated necroptosis may partially account for the hyperinflammation and excessive oxidative stress induced by SESN2 deficiency.

CONCLUSION:

Our results suggested that SESN2 inhibited RIPK3-mediated necroptosis; this regulation is an important for the immune homeostasis and the redox balance in the liver.

01 Aug 2024·Mini reviews in medicinal chemistry

SMAC Mimetics for the Treatment of Lung Carcinoma: Present Development and Future Prospects

Article

Author: Bisht, Priya ; Ravichandiran, V ; Murti, Krishna ; Kumar, Nitesh ; Wal, Pranay ; Pandey, Ruchi

Background::

Uncontrolled cell growth and proliferation, which originate from lung tissue often lead to lung carcinoma and are more likely due to smoking as well as inhaled environmental toxins. It is widely recognized that tumour cells evade the ability of natural programmed death (apoptosis) and facilitates tumour progression and metastasis. Therefore investigating and targeting the apoptosis pathway is being utilized as one of the best approaches for decades.

Objective::

This review describes the emergence of SMAC mimetic drugs as a treatment approach, its possibilities to synergize the response along with current limitations as well as future perspective therapy for lung cancer.

Method::

Articles were analysed using search engines and databases namely Pubmed and Scopus.

Result::

Under cancerous circumstances, the level of Inhibitor of Apoptosis Proteins (IAPs) gets elevated, which suppresses the pathway of programmed cell death, plus supports the proliferation of lung cancer. As it is a major apoptosis regulator, natural drugs that imitate the IAP antagonistic response like SMAC mimetic agents/Diablo have been identified to trigger cell death. SMAC i.e. second mitochondria activators of caspases is a molecule produced by mitochondria, stimulates apoptosis by neutralizing/inhibiting IAP and prevents its potential responsible for the activation of caspases. Various preclinical data have proven that these agents elicit the death of lung tumour cells. Apart from inducing apoptosis, these also sensitize the cancer cells toward other effective anticancer approaches like chemo, radio, or immunotherapies. There are many SMAC mimetic agents such as birinapant, BV-6, LCL161, and JP 1201, which have been identified for diagnosis as well as treatment purposes in lung cancer and are also under clinical investigation.

Conclusion::

SMAC mimetics acts in a restorative way in the prevention of lung cancer.

71

News (Medical) associated with Xevinapant

25 Jun 2024

·www.fiercebiotech.com

Merck KGaA drops xevinapant with phase 3 head and neck cancer trial on course for failure

Merck licensed xevinapant back in 2021 via a $855 million pact with Swiss biotech Debiopharm. Just last month, Merck KGaA executives were reassuring analysts that the failure of a phase 3 trial of xevinapant was “unlikely.” Now that worst-case scenario has come to pass. The company will now halt both studies on what was once a key brick in the German pharma’s oncology wall. The TrilynX study was evaluating the apoptosis proteins inhibitor alongside chemoradiotherapy in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). In an earnings call with analysts in May, Merck’s Healthcare CEO Peter Guenter said “no news is good news” when it came to the upcoming pre-planned interim analysis of the study. Only when pushed by an analyst on the May 15 call did Guenter admit that there was also a “worst-case scenario” where the company would be forced to divulge that the trial was heading for failure. Merck has now confirmed the worst case in a post-market announcement yesterday, disclosing that the interim analysis has concluded that the TrilynX study is unlikely to meet its primary objective of prolonging event-free survival. The company said that LA SCCHN has “proven to be a difficult-to-treat form of cancer.” “Chemoradiotherapy has remained the standard of care for decades, despite multiple studies designed to improve outcomes with new treatment approaches, including multiple immunotherapy trials,” the company pointed out in the June 24 release. Topline safety data from the trial were “overall compatible with the chemo-radio sensitizing properties of xevinapant,” Merck added. “While we are disappointed by these results, we remain steadfast in our commitment to develop transformative medicines within our oncology portfolio for areas of high unmet need,” Danny Bar-Zohar, M.D., global head of R&D and chief medical officer for Merck’s healthcare business, said in the release. The company added that “given the totality of the data,” another trial of xevinapant will be halted—the phase 3 X-Ray Vision study in patients who have undergone resection of locally advanced head and neck cancer. Inhibitors of apoptosis proteins, in the form of xevinapant, had been one of the pillars of Merck’s oncology pipeline, alongside antibody-drug conjugates and DNA damage response (DDR) kinase inhibitors. Merck licensed xevinapant back in 2021 via a $855 million pact with Swiss biotech Debiopharm. A year later, Bar-Zohar was specifically highlighting the Debiopharm agreement as the kind of deal the company hoped to replicate. In yesterday’s release, Merck stressed that its support for the head and neck cancer community “remains steadfast” thanks to the EGFR inhibitor Erbitux, which the pharma commercializes outside of the U.S. and Canada, where it is marketed by Eli Lilly. Assessing the impact of xevinapant's failure, analysts at ODDO BHF said they had identified “blockbuster potential” in the candidate and put the drug's failure in the context of the end of Merck's evobrutinib ambitions in March. “The failure of xevinapant is clearly very negative as the drug was seen as the strongest drug pipeline candidate for the near future of the company,” the analysts wrote in a June 25 note. “The stop is a further major setback for Merck and counteracts its objective to launch a meaningful drug every 1.5 years.” Merck's stock was trading down 8% at 153.65 euros on the Frankfurt Stock Exchange as of 2:18 pm local time.

Phase 3ADCImmunotherapy

25 Jun 2024

·firstwordpharma.com

Merck KGaA’s latest pipeline woes place more urgency on deals

Merck KGaA’s shares fell as much as 10% on Tuesday as the latest late-stage failure – this time for xevinapant – raised more questions over the company’s pharmaceutical pipeline and its ability to meet growth targets. "This is (another) surprising setback for the healthcare pipeline. We continue to like the Merck story, but concede the company will need to rebuild credibility regarding its pipeline prowess," Barclays analysts remarked.Xevinapant – which Merck in-licensed from Debiopharm – was being studied in the Phase III TrilynX and X-Ray Vision trials for patients with head and neck squamous cell carcinoma (HNSCC). The company said Monday that both studies would be discontinued after an interim analysis determined that TrilynX was unlikely to meet its primary endpoint of improving event-free survival. The inhibitor-of-apoptosis proteins (IAP) antagonist was Merck’s lead oncology pipeline asset and its failure follows a similar fate for the BTK inhibitor evobrutinib in multiple sclerosis in March. Following the two setbacks, analysts at Stifel Nicolaus said Merck “has little to show for internal and externally licensed R&D that are supposed to shoulder some Mavenclad/Cladribine expiry in 2027.”Larger deals likelyMeanwhile, analysts at Morgan Stanley noted that “whilst xevinapant was not key to our investment thesis, this headline further challenges the growth outlook of the healthcare business,” adding “there is now likely more debate on how to reinvigorate R&D at [the] healthcare business, which continues to weigh on shares.” Merck had pinned its hopes on the success of evobrutinib and xevinapant in helping the healthcare segment achieve growth in the mid-single-digit percentage range over the medium term.Morgan Stanley analysts also noted that while “Merck's management believes that the healthcare business could still grow even without xevinapant… we believe Merck may now be more likely to reallocate capital to larger healthcare deals in order to rebuild the pipeline.” In March, the pharma’s CEO Belén Garijo said that moving forward, more than 50% of its drug launches are expected to come from external innovation, adding that deals “allow us to pick the desired assets to complement our portfolio.”

Phase 3

25 Jun 2024

·www.pharmaceutical-technology.com

Merck KGaA abandons Phase III trial for $1.08bn head & neck cancer drug

Merck licenced xevinapant from Debiopharm International in 2021 in a deal worth $1.08bn. Image Credit: Anne Czichos / Shutterstock Merck KGaA (Merck) has discontinued the Phase III TrilynX trial evaluating xevinapant in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). The company stated that its decision was informed by a pre-planned interim analysis performed by the Independent Data Monitoring Committee. It found that the study is “unlikely to meet its primary objective of prolonging event-free survival”. Merck licenced xevinapant from Debiopharm International in a deal worth $1.08bn in 2021. Xevinapant is an inhibitor of apoptosis protein (IAP) antagonist designed to restore cancer cell sensitivity to apoptosis. Following the news of trial termination, Merck’s stock was down by over 10% in trading on the Frankfurt Stock Exchange. The randomised placebo-controlled Phase III TrilynX trial (NCT04459715) enrolled approximately 730 participants with LA SCCHN. The study evaluated xevinapant in combination with chemoradiation therapy versus placebo and chemoradiation. The trial’s primary endpoint was event-free survival for up to five years. See Also: AstraZeneca’s Tagrisso receives approval in Japan for lung cancer AstraZeneca’s Truqap and Faslodex combo receives approval in EU Merck was quick to add that the safety data for xevinapant was “overall compatible with the chemo-radio sensitizing properties of the therapy”. The company plans to conduct an in-depth review of the data and share these results in the future. Xevinapant was touted as Merck’s big oncology therapy, per its 2023 annual statement. The company prioritised its importance, especially after its multiple sclerosis therapy, evobrutinib, failed to meet primary endpoints in Phase II trials . Other therapies in the company’s oncology portfolio are HRS-1167, a selective poly (ADP-ribose) polymerase 1 (PARP1) trapping inhibitor, and a Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904. Merck licenced the therapies from Chinese company Jiangsu Hengrui Pharmaceuticals in a deal worth up to $1.48bn, in October 2023. In April, Merck invested over €300m ($320.8m) in a new Life Science Research Center at its global headquarters in Darmstadt, Germany. The centre, which is expected to open in 2027, will be responsible for developing biopharmaceuticals, including antibodies and messenger ribonucleic acid applications.

Phase 3ADCDrug ApprovalPhase 2

100 Deals associated with Xevinapant

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16305

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Squamous Cell Carcinoma of Head and Neck	Phase 3	US	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	CN	Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	CN	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	JP	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	AR	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	AT	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	BE	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	BR	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	CA	EMD Serono Research & Development Institute, Inc.	06 Oct 2022
Squamous Cell Carcinoma of Head and Neck	Phase 3	CZ	EMD Serono Research & Development Institute, Inc.	06 Oct 2022

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04459715 (TrilynX, BusinessWire) Manual	Phase 3	Locally Advanced Head and Neck Squamous Cell Carcinoma	-	xevinapant + CRT	isnhvteyfw(ttmsdstaic) = the trial would be unlikely to meet its primary objective of prolonging event-free survival. vbdmdzqwab (xfzkxlgbjv ) Not Met	Negative	24 Jun 2024
NCT02022098 (ASCO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	96	Xevinapant + CRT	qggriieeje(rmuybysuid) = fmiqmqsbmc xpeujaeojc (lwctalqngb ) View more	Positive	24 May 2024
				Placebo + CRT	qggriieeje(rmuybysuid) = awzlmypufi xpeujaeojc (lwctalqngb ) View more
NCT04122625 (CTgov)	Phase 1/2	Solid tumor	46	nivolumab+Debio 1143 (Part A - Debio 1143 150 mg + Nivolumab)	apvwlojnbf(bbvkndluyq) = waheeeword thvidrspvu (athpqqcbxw, nrvbsnzjko - clertzrpjo) View more	-	12 Jun 2023
				nivolumab+Debio 1143 (Part A - Debio 1143 200 mg + Nivolumab)	apvwlojnbf(bbvkndluyq) = tcqdqnbvrf thvidrspvu (athpqqcbxw, bqcmqwcnfa - tthenjuujl) View more
AACR2023 Manual	Phase 1	Non-Small Cell Lung Cancer	38	xevinapant 200 mg/day+avelumab 10 mg/kg	yaxbexdnya(ctwgmqpwjv) = pwpssthxmc ygnnkhkaqx (dlhswtimii, 2.9 - 24.8) View more	Negative	14 Apr 2023
NCT02022098 (Pubmed)	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma	96	Xevinapant 200 mg/day	aucmiscbqp(bouidddemk) = fmhmangndg xfffekymsb (vkbdkxiukc, 40.3 - not evaluable)	Positive	01 Apr 2023
				Placebo	aucmiscbqp(bouidddemk) = uymkerpjlq xfffekymsb (vkbdkxiukc, 21.8 - 46.7)
NCT02022098 (ESMO2022) Manual	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma HPV Positive	96	Xevinapant 200 mg+CRT	crpaxpldca(qllutkakiu) = cevtdbrpfv aevwmqzzjc (xzwvvdejxq, 37 - 66) View more	Positive	10 Sep 2022
				Placebo + CRT	crpaxpldca(qllutkakiu) = cfgwsyzyqf aevwmqzzjc (xzwvvdejxq, 15 - 42) View more
NCT03871959 (CATRIPCA, ESMO2022) Manual	Phase 1	Colorectal Cancer \| Metastatic Pancreatic Ductal Adenocarcinoma MSI-Low	41	Pembrolizumab+Xevinapant (Dose escalation cohort)	bnhykwzrqh(daoulvmfxp) = Xevinapant 200mg/d + pembrolizumab 200mg q3w jnadzymtzv (vhnbnayhfh ) View more	Negative	10 Sep 2022
				Pembrolizumab+Xevinapant (PDAC expansion cohort)
NCT02022098 (ESMO2020) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	96	Cisplatin+CRT+xevinapant	zeecxcswwt(sfkueguulz) = suyolksddn gtbwyegmxl (qeznttrwhi ) View more	Positive	19 Sep 2020
				Cisplatin+CRT+placebo	zeecxcswwt(sfkueguulz) = ukmqmqflyz gtbwyegmxl (qeznttrwhi, 21.8 - 46.7) View more
NCT04122625 (ESMO2020) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	11	Debio 1143+nivolumab (phase Ib)	pwcgqejhpv(maemfxwqci) = Debio 1143 at 200 mg/d + nivolumab 240 mg q2w spafmwlxlt (iadsuyqzhs ) View more	Positive	17 Sep 2020
NCT02022098 (Pubmed) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	48	Debio 1143	toxsdcpfns(gklqtncbrg) = etisrkthni bzuowhypqr (xffazguswq, 39 ~ 69) View more	Positive	01 Sep 2020
				Placebo	toxsdcpfns(gklqtncbrg) = rjffdjrfor bzuowhypqr (xffazguswq, 20 ~ 48) View more