Exploration of Targeted Anti-tumor Therapy

Table 4. Ongoing clinical trials in ARID1A-mutated cancers

Clinical trial number	Phase	Randomization	Disease	Setting	Experimental arm	Control arm	Primary objective	Status
NCT05023655	2	No	Solid tumor	Advanced	Tazemetostat	NA	ORR	Recruiting
NCT04284202	2	No	NSCLC	Advanced	PD-1 + dasatinib	NA	PFS	Unknown
NCT04065269	2	No	Ovarian and endometrial clear cell carcinoma	Advanced	AZD6738 +/– olaparib	NA	ORR	Recruiting
NCT04953104	2	No	Urothelial cancer	Advanced	Nivolumab	NA	ORR	Not yet recruiting
NCT04957615	2	No	Solid tumor	Advanced	Nivolumab	NA	ORR	Recruiting
NCT05154994	1	No	Urothelial cancer	Advanced	Tremelimumab + durvalumab + belinostat	NA	RP2D	Recruiting
NCT04633902	2	No	Melanoma	Advanced	Olaparib + pembrolizumab	NA	ORR	Recruiting
NCT03682289	2	No	Solid tumor	Advanced	AZD6738 +/– olaparib	NA	ORR	Recruiting
NCT02576444	2	No	Solid tumor	Advanced	AZD5363 + olaparib	NA	ORR	Active, not recruiting
NCT05379972	2	No	Gastric cancer	Advanced	Pembrolizumab + olaparib + SBRT	NA	ORR	Not yet recruiting
NCT03207347	2	No	Solid tumor	Advanced	Niraparib	NA	ORR	Active, not recruiting
NCT04042831	2	No	Biliary tract cancer	Advanced	Olaparib	NA	ORR	Recruiting
NCT04104776	1-2	No	Solid tumor, lymphoma	Advanced	CPI-0209	NA	DLTs; ORR	Recruiting

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ORR: overall response rate; NSCLC: non-small cell lung cancer; PD-1: programmed death-1; RP2D: recommended phase 2 dose; SBRT: stereotactic body radiation therapy; AZD6738: ceralasertib; CPI-0209: tulmimetostat; DLTs: dose-limiting toxicities

Declarations

Author contributions

RF: Conceptualization, Formal analysis, Data curation, Writing—review & editing. GD: Conceptualization, Supervision. MF and PL: Data curation. VA and FPS: Formal analysis. GS: Supervision. All authors read and approved the submitted version.

Conflicts of interest

RF, MF, PL, VA, and FPS declare that they have no conflicts of interest. GS has served on advisory boards for TESARO Bio Italy S.r.l, Johnson & Johnson, Clovis Oncology Italy S.r.l. He received support for travel or accommodation from MSD Italy S.r.l and Clovis Oncology Italy S.r.l. GD has served on advisory board of Beigene and received support for travel and accommodation from Roche.

Ethical approval

The study complies with the declaration of Helsinki and was approved by the Ethics Committee of Fondazione Policlinico Universitario A. Gemelli IRCCS (ID5261).

Consent to participate

Informed consent to participate in the study was obtained from all participants.

Consent to publication

Not applicable.

Availability of data and materials

The data generated in the present study can be requested from the corresponding author (Gennaro Daniele, gennaro.daniele@policlinicogemelli.it).

Funding

Not applicable.

Copyright

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