Drug · Small Molecule

Sapanisertib

CI-DRUG-00000542Explore in graph →NCIt C90548 CHEMBL3545097 CIViC Phase 2

Regulatory

Approvals (0)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Trials	Jurisdictions	First approval	First trial
All cancers	Phase2	Phase 2	10	3	45	—	—	Jan 4, 2010
Malignant Lung Neoplasm	Phase2	Phase 2	3	0	8	—	—	Aug 17, 2015
Malignant Uterine Corpus Neoplasm	Phase2	Phase 2	3	1	4	—	—	May 20, 2014
Multiple Myeloma	Phase2	Phase 2	3	0	4	—

Curated evidence

Clinical evidence (6)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–6 of 6 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
RICTOR Amplification2
Onatasertib + Sapanisertib

Clinical trials

Trials with this intervention (45)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–45 of 45 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06811116	Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial	recruiting	Phase 1 / Phase 2	92	National Cancer Institute (NCI)NIH	1	Sep 3, 2026	clinicaltrials
NCT02142803	TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors

NFE2L2 Mutation2
Sapanisertib	Lung Squamous Cell Carcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID7425 In a phase 2 trial, patients with squamous cell lung carcinoma harboring NFE2L2 mutation were treated with oral TORC1/2 inhibitor TAK228. ORR 25% (1 PR, 3 SD, 0 PD). Open in CIViC	civic
〃	Lung Squamous Cell Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID7446 In an NCI-CTEP phase 2 trial, patients with squamous cell lung carcinoma with NFE2L2 mutations were treated with TORC1/2 inhibitor TAK-228. The response rate was 29% (2/7）and disease control rate was … (full text at CIViC) Open in CIViC	civic

NFE2L2 Mutation2

Sapanisertib

Lung Squamous Cell Carcinoma

Predictive

Supports Sensitivity Response

submitted

EID7425

In a phase 2 trial, patients with squamous cell lung carcinoma harboring NFE2L2 mutation were treated with oral TORC1/2 inhibitor TAK228. ORR 25% (1 PR, 3 SD, 0 PD).

Open in CIViC

civic

〃

Lung Squamous Cell Carcinoma

Predictive

Supports Sensitivity Response

accepted

EID7446

In an NCI-CTEP phase 2 trial, patients with squamous cell lung carcinoma with NFE2L2 mutations were treated with TORC1/2 inhibitor TAK-228. The response rate was 29% (2/7）and disease control rate was … (full text at CIViC)

Open in CIViC

civic

AKT1 Mutation + AKT2 Mutation + MTOR Mutation + PIK3CA Mutation + PTEN MutationMTOR PIK3CA PTEN AKT1 AKT21
Sapanisertib	Solid NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID12075 In this study, 30 patients with advanced solid malignancies harboring mTOR/AKT/PI3K pathway alterations were treated with Sapanisertib. The tumor types included sarcomas, breast, ovarian, head and nec… (full text at CIViC) PMID 38126764 · Subbiah et al., 2024 · Open in CIViC	civic

AKT1 Mutation + AKT2 Mutation + MTOR Mutation + PIK3CA Mutation + PTEN MutationMTOR PIK3CA PTEN AKT1 AKT21

Sapanisertib

Solid NeoplasmCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12075

In this study, 30 patients with advanced solid malignancies harboring mTOR/AKT/PI3K pathway alterations were treated with Sapanisertib. The tumor types included sarcomas, breast, ovarian, head and nec… (full text at CIViC)

PMID 38126764 · Subbiah et al., 2024 · Open in CIViC

civic

RET Mutation1
NVP-AST487 + SapanisertibCombination	Thyroid Gland Carcinoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID4854 The objective of this preclinical study was to investigate the contribution of mTOR activity to RET-induced signaling and cell growth and to establish whether growth suppression is enhanced by co-targ… (full text at CIViC) PMID 23828865 · Gild et al., 2013 · Open in CIViC	civic

RET Mutation1

NVP-AST487 + SapanisertibCombination

Thyroid Gland Carcinoma

Predictive

Supports Sensitivity Response

submitted

EID4854

The objective of this preclinical study was to investigate the contribution of mTOR activity to RET-induced signaling and cell growth and to establish whether growth suppression is enhanced by co-targ… (full text at CIViC)

PMID 23828865 · Gild et al., 2013 · Open in CIViC

civic