Table Info

Table 5.

Active trials, both recruiting and not recruiting, testing targets not aforementioned (IDH, FGFR, PARP, HER2, ALK, ROS, and the MAPK pathway)

NCT	Phase	Status	Tumors	Line of treatment	Target	Experimental treatment	Standard treatment	Primary endpoints	Sponsor
NCT04491942	1	Recruiting	CCA	UNK	ATR*	Cis + BAY 1895344 +/– Gem	N.A.	AEs, RP2D	No-profit
NCT03829436	1	Recruiting	CCA	NTA	PPAR-alfa*	TPST-1120 +/– nivolumab	N.A.	DLT, AEs, MTD	Profit
NCT04430842	1	Recruiting	CCA	NTA	LAT1	QBS10072S	N.A.	MTD	Profit
NCT04152018	1	Recruiting	eCCA	UNK	Integrin alpha-V/beta-8*	PF 06940434 +/– IT	N.A.	DLT, AEs, ORR, PFS, DOR	Profit
NCT03422679	1/2	Recruiting	CCA	NTA	NOTCH*	CB-103	N.A.	DLT, ORR	Profit
NCT03907852	1/2	Recruiting	CCA	≥ 2 L	Protein mesothelin	Gavo-cel	N.A.	3 months ORR	Profit
NCT04068194	1/2	Recruiting	CCA and gallbladder cancer	NTA	DNA activated protein kinase (DNA-PK)*	Nedisertib	N.A.	MTD, ORR	Profit
NCT03633773	1/2	Recruiting	iCCA	1 L	Glycosylated Mucin1	MUC-1 CART cell IT	N.A.	DCR	No-profit
NCT03768375	2	Recruiting	eCCA, gallbladder cancer	1 L	Precision target therapy based on tumor molecular profiling	FORFIRINOX or cetuximab or trastuzumab or gefitinib or lapatinib or everolimus or sorafenib or crizotinib	FOLFIRINOX	PFS	No-profit
NCT03801915	2	Recruiting	CCA	Perioperative	CA 19-9 epitope	MVT-5873	N.A.	1-year recurrence rates, safety	Profit
NCT04034238	2	Recruiting	eCCA	2 L	Protein mesothelin	LMB-100 + tofacitinib	N.A.	Safety, timing of anticorpal response	Profit
NCT04383210	2	Recruiting	CCA and gallbladder cancer	NTA	NRG1 gene fusion	Seribantumab	N.A.	ORR	Profit
NCT03102320	1b	Completed	CCA	UNK	Protein mesothelin	Anetumab ravtansine + chemotherapy	N.A.	MTD, ORR, DOR	Profit
NCT00101972	1	Completed	CCA and gallbladder cancer	2–4 L	Glycotope RAAG12*	RAV12	N.A.	Toxicity by CTCAE	Profit
NCT00020579	1	Completed	CCA and gallbladder cancer	NTA	Histone deacetylase*	Entinostat	N.A.	DLT, MTD, pharmaco-kinetics	No-profit
NCT00027534	1	Completed	Gallbladder cancer	Received prior therapy with possible survival benefit or refused such therapy	CEA	TRICOM-CEA(6D)	N.A.	Safety and feasibility	No-profit
NCT02836847	2	UNK	eCCA and gallbladder cancer	1 L	Precision target therapy based on tumor molecular profiling	GEMOX + cetuximab or trastuzumab or gefitinib or lapatinib or everolimus or sorafenib or crizotinib	GEMOX	PFS	No-profit
NCT04895046	2	Not yet recruiting	CCA	Maintenance	Defined HRD signature	Niraparib and dostarlimab	N.A,	PFS	Profit
NCT04801095	1	Recruiting	CCA	1 L	pTyr-mtRTK	WM-S1-030	N.A.	MTD	Profit
NCT05001282	1/2	Not yet recruiting	CCA	NTA	FRα over-expressing	ELU001	N.A.	MTD/RP2D	Profit

We reported four trials defined as “completed” on www.clinicaltrials.gov, whose results have never been published. Were excluded a “terminate” trial, that is a study stopped early, whose participants are no longer being examined or treated (NCT00012246), and two “withdrawn” trials, stopped early, before enrolling their first participants (NCT01501604 and NCT01859182). *Not inclusion criteria; ATR: ataxia-telangiectasia mutated (ATM) and RAD3-related; LAT: large amino acid transporter; FOLFIRINOX: leucovorin calcium, fluorouracil, irinotecan hydrochloride and oxaliplatin; CA: carbohydrate antigen; NRG1: neuroregulin1; CTCAE: common terminology criteria for adverse events; CEA: carcinoembryonic antigen; HRD: homologous recombination deficency; RTK: receptor tyrosine kinases; FRα: folate receptor alpha

Declarations

Author contributions

MDM, DM, ES contributed conception and design of the review; AC, TG, FDV organized the database; GA, CP, CZ wrote the first draft of the manuscript. All authors contributed to manuscript revision, read and approved the submitted version.

Conflicts of interest

The authors declare the following financial interests/personal relationships that may be considered as potential competing interests: Massimo Di Maio received honoraria and had roles as consultant or advisor for AstraZeneca, Pfizer, Novartis, Roche, Takeda, Eisai, Janssen, Astellas; received institutional research grant by Tesaro e GlaxoSmithKline, outside the submitted work. All remaining authors declared no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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