IDH1 mutant: Gene Variant Detail - Cancer Knowledgebase (CKB)

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT04396860	Phase II	Temozolomide Ipilimumab + Nivolumab	Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma	Active, not recruiting	USA	0
NCT04606316	Phase I	Nivolumab Ipilimumab + Nivolumab	Surgical Nivolumab And Ipilimumab For Recurrent GBM	Active, not recruiting	USA	0
NCT04908176	Phase I	Avapritinib + Midazolam	A Drug-drug Interaction Study of Avapritinib and Midazolam	Completed	USA	0
NCT06668584	Phase Ib/II	Olutasidenib	A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients with IDH1-mutated Myeloid Malignancies	Recruiting	USA	0
NCT02968940	Phase II	Avelumab	Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma	Completed	USA	0
NCT02677922	Phase Ib/II	Azacitidine + Ivosidenib Azacitidine Azacitidine + Enasidenib	A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy	Active, not recruiting	USA \| SWE \| NLD \| ITA \| GBR \| FRA \| ESP \| DEU \| CHE \| CAN \| BEL \| AUS	2
NCT02632708	Phase I	Enasidenib + Etoposide + Mitoxantrone Cytarabine + Enasidenib Cytarabine + Idarubicin + Ivosidenib Cytarabine + Daunorubicin + Enasidenib Cytarabine + Enasidenib + Idarubicin Etoposide + Ivosidenib + Mitoxantrone Cytarabine + Ivosidenib Cytarabine + Daunorubicin + Ivosidenib	Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation	Active, not recruiting	USA \| NLD \| DEU	0
NCT05345002	Phase II	Retifanlimab + Tretinoin	All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma	Recruiting	USA	0
NCT02525692	Phase II	ONC201	Oral ONC201 in Recurrent GBM, H3 K27M Glioma, and Midline Glioma	Terminated	USA	0
NCT05218408	Phase Ib/II	Cyclophosphamide + Fludarabine CYNK-001	CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type (CYNK001GBM02)	Withdrawn		0
NCT04988555	Phase Ib/II	DSP-5336	A Study of DSP-5336 in Relapsed/refractory AML/ ALL with or Without MLL Rearrangement or NPM1 Mutation	Recruiting	USA \| ITA \| GBR \| FRA \| ESP \| CAN \| BEL	4
NCT06831526	Phase I	Azeliragon + Temozolomide	Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma	Not yet recruiting	USA	0
NCT05283109	Phase I	P30-EPS + Poly ICLC	ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM (ETAPA I)	Recruiting	USA	0
NCT06095375	Phase I	Regorafenib + Temozolomide	Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients (REGOMA-2)	Active, not recruiting	ITA	0
NCT06566742	Phase II	Olutasidenib	A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.	Recruiting	USA	0
NCT02576444	Phase II	Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib	OLAParib COmbinations (OLAPCO)	Terminated	USA	0
NCT04955938	Phase I	Enasidenib + Fedratinib Fedratinib + Ivosidenib	A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms	Withdrawn	USA	0
NCT04278781	Phase II	Ivosidenib	AG-120 in People With IDH1 Mutant Chondrosarcoma	Active, not recruiting	USA	0
NCT04555577	Phase I	Peposertib Temozolomide	Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma	Recruiting	USA	0
NCT04774393	Phase Ib/II	Decitabine and Cedazuridine + Ivosidenib + Venetoclax Decitabine and Cedazuridine + Enasidenib + Venetoclax	Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia	Recruiting	USA	0
NCT02071862	Phase I	Everolimus + Telaglenastat Erlotinib + Telaglenastat Docetaxel + Telaglenastat Telaglenastat Paclitaxel + Telaglenastat Cabozantinib + Telaglenastat	Study of the Glutaminase Inhibitor CB-839 in Solid Tumors	Completed	USA	0
NCT05627323	Phase I	CHM-1101	CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma	Active, not recruiting	USA	0
NCT03173248	Phase III	Azacitidine Azacitidine + Ivosidenib	Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE)	Active, not recruiting	USA \| POL \| NLD \| ITA \| ISR \| GBR \| FRA \| ESP \| DEU \| CZE \| CAN \| BRA \| AUT \| AUS	6
NCT03220646	Phase II	Abemaciclib	Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors	Active, not recruiting	USA	0
NCT03922555	Phase I	Decitabine and Cedazuridine	ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas	Recruiting	USA	0
NCT03503409	Phase II	Ivosidenib	IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome	Active, not recruiting	ITA \| FRA	0
NCT06597734	Phase II	Decitabine and Cedazuridine + Olutasidenib Azacitidine + Olutasidenib Decitabine + Olutasidenib	A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm	Recruiting	USA	0
NCT03212274	Phase II	Olaparib	Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations	Active, not recruiting	USA	0
NCT05474378	Phase I	Retroviral vector transduced B7-H3 CAR T cells	B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme	Active, not recruiting	USA	0
NCT04559230	Phase II	Sacituzumab govitecan-hziy	Sacituzumab Govitecan in Recurrent Glioblastoma	Recruiting	USA	0
NCT03878095	Phase II	Ceralasertib + Olaparib	Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors	Active, not recruiting	USA	0
NCT02981940	Phase II	Abemaciclib	A Study of Abemaciclib in Recurrent Glioblastoma	Active, not recruiting	USA	0
NCT05099003	Phase Ib/II	Selinexor	A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)	Suspended	USA \| NZL \| CAN \| AUS	0
NCT05463848	Phase II	Olaparib + Pembrolizumab + Temozolomide Pembrolizumab	Surgical Pembro +/- Olaparib W TMZ for RGBM	Recruiting	USA	0
NCT05432375	Phase I	Tinostamustine	Study of Tinostamustine for Adjuvant Treatment of Glioblastoma	Active, not recruiting	ESP \| CHE	0
NCT04945148	Phase II	Metformin + Temozolomide	Oxidative Phosphorylation Targeting In Malignant Glioma Using Metformin Plus Radiotherapy Temozolomide (OPTIMUM)	Recruiting	ITA \| FRA	0
NCT06636162	Phase I	DSP-0390	Window of Opportunity Study of DSP-0390 in Gliomas	Not yet recruiting	USA	0
NCT05743595	Phase I	Personalized cancer vaccine + Retifanlimab	Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma	Recruiting	USA	0
NCT05432804	Phase Ib/II	Selinexor + Temozolomide Temozolomide	Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment	Recruiting	USA	0
NCT06413706	Phase II	Abemaciclib + Temozolomide Temozolomide	A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy	Recruiting	USA \| ROU \| NLD \| ITA \| FRA \| ESP \| DNK \| BEL \| AUS	1
NCT03701295	Phase Ib/II	Azacitidine + Pinometostat	Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement	Completed	USA	0
NCT03127735	Phase I	BAY1436032	BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)	Completed	USA \| DEU	0
NCT06297512	Phase II	Doxorubicin + Temozolomide	Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).	Recruiting	ITA	0
NCT05326464	Phase III	Tofacitinib	Tofacitinib in Recurrent GBM Patients	Recruiting	USA	0
NCT03207347	Phase II	Niraparib	A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)	Completed	USA	0
NCT03139916	Phase II	Bavituximab + Temozolomide	Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma	Completed	USA	0
NCT04729959	Phase II	Atezolizumab + Tocilizumab	Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma	Active, not recruiting	USA	0
NCT05756777	Phase I	Gilteritinib + Ivosidenib Enasidenib + Gilteritinib	A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)	Recruiting	USA	0
NCT06543381	Phase I	Olutasidenib	Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant	Recruiting	USA	0
NCT02492737	Phase I	Vorasidenib	Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation	Completed	USA \| FRA	0
NCT04629209	Phase II	ONC201	A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma	Withdrawn	USA	0
NCT04195555	Phase II	Ivosidenib	Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)	Active, not recruiting	USA \| AUS	1
NCT06455605	Phase Ib/II	2141 V-11 + D2C7-IT	D2C7-IT + 2141-V11 Combination Post-resection in rGBM	Recruiting	USA	0
NCT02073994	Phase I	Ivosidenib	Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation	Completed	USA \| FRA	0
NCT05183204	Phase II	GDC-0084 + Metformin	Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma	Recruiting	USA	0
NCT06291987	Phase I	Ivosidenib + Ruxolitinib	Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation (MPN)	Recruiting	USA	0
NCT04764474	Phase I	HMPL-306	A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH	Recruiting	USA \| ESP	0
NCT02989857	Phase III	Ivosidenib	Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)	Completed	USA \| ITA \| GBR \| FRA \| ESP	1
NCT04762602	Phase I	HMPL-306	A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations	Active, not recruiting	USA \| ESP	0
NCT03749187	Phase I	Pamiparib + Temozolomide	BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas (PNOC017)	Recruiting	USA	0
NCT06478212	Phase Ib/II	Temozolomide + Vorasidenib	Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma	Recruiting	USA \| NLD \| ITA \| ISR \| GBR \| FRA \| ESP \| DEU \| AUT	2
NCT05222802	Phase I	ERAS-801	A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)	Active, not recruiting	USA	0
NCT05538572	Phase I	PRT3645	A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors	Completed	USA	1
NCT06776250	Phase II	Tarlatamab	Study of How Safe and Effective Tarlatamab is in Brain Cancers	Not yet recruiting	CAN	0
NCT04576117	Phase III	Selumetinib Selumetinib + Vinblastine	A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma	Recruiting	USA \| CAN	0
NCT02858895	Phase II	MDNA55	Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma	Completed	USA	0
NCT03047993	Phase Ib/II	Azacitidine + Telaglenastat	Glutaminase Inhibitor CB-839 and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndrome	Completed	USA	0
NCT02428855	Phase II	Dasatinib	Phase II Trial of Dasatinib in Patients With Isocitrate Dehydrogenase (IDH)-Mutant Advanced Intrahepatic Cholangiocarcinoma	Completed	USA	0
NCT05180825	Phase II	Vinblastine Trametinib	Pediatric Low Grade Glioma - MEKinhibitor TRIal vs Chemotherapy (PLGG - MEKTRIC)	Recruiting	FRA	0
NCT03718767	Phase II	Nivolumab	Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype	Active, not recruiting	USA	0
NCT05052957	Phase II	Carmustine + Filgrastim + O6-benzylguanine + Temozolomide	hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) (hSTAR GBM)	Recruiting	USA	0
NCT02481154	Phase I	Vorasidenib	Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation	Completed	USA	0
NCT06258018	Phase Ib/II	Niraparib + Temozolomide	Niraparib and Temozolomide in Patients Glioblastoma (ONC-2022-001)	Not yet recruiting	ITA	0
NCT05401097	Phase II	Azacitidine + Enasidenib + Venetoclax Azacitidine + Ivosidenib + Venetoclax	IDH Targeted/non- Targeted Vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)	Recruiting	USA	0
NCT03991832	Phase II	Durvalumab + Olaparib	Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors (SOLID)	Recruiting	CAN	0
NCT03158389	Phase Ib/II	Vismodegib Alectinib Idasanutlin Temsirolimus Atezolizumab Palbociclib APG101	NCT Neuro Master Match - N²M² (NOA-20) (N²M²)	Completed	DEU	0
NCT03430791	Phase II	Ipilimumab + Nivolumab Nivolumab	Trial of Combination TTF(Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma	Terminated	USA	0
NCT06719362	Phase I	M3T01 M3T01 + Temozolomide M3T01 + Pembrolizumab Fluorouracil + Leucovorin + M3T01 + Oxaliplatin + Pembrolizumab	A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies	Not yet recruiting	USA	0
NCT04015700	Phase I	GNOS-PV01 + Rocakinogene sifuplasmid	Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma	Active, not recruiting	USA	0
NCT05879120	Phase II	Pembrolizumab	Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab With and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma	Withdrawn	USA	0
NCT05588141	Phase Ib/II	Zotiraciclib	A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations	Recruiting	USA	0
NCT05417594	Phase Ib/II	AZD9574 AZD9574 + Temozolomide	Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1)	Recruiting	USA \| SWE \| GBR \| ESP \| DEU \| AUS	1
NCT05766514	Phase II	Cladribine + Cytarabine + Decitabine Decitabine + Venetoclax Azacitidine + Venetoclax	Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction	Not yet recruiting	USA	0
NCT05376800	Phase I	BI 907828	A Study to Determine How BI 907828 (Brigimadlin) is Taken up in the Tumor (Phase 0) and to Determine the Highest Dose of BI 907828 (Brigimadlin) That Could be Tolerated (Phase 1a) in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma	Active, not recruiting	USA \| ESP \| BEL	0
NCT05188508	Phase II	Olaparib + Pembrolizumab + Temozolomide	Pembrolizumab, Olaparib, and Temozolomide for People with Glioma	Recruiting	USA	0
NCT05406700	Phase I	Niraparib	Niraparib In Recurrent IDH 1/2 Gliomas	Recruiting	USA	0
NCT05465954	Phase II	NT-I7 + Pembrolizumab	Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma	Recruiting	USA	0
NCT04118036	Phase II	Abemaciclib + Pembrolizumab	Abemaciclib + Pembrolizumab In Glioblastoma	Withdrawn	USA	0
NCT03557359	Phase II	Nivolumab	Nivolumab for Recurrent or Progressive IDH Mutant Gliomas	Active, not recruiting	USA	0

Gene	IDH1
Variant	mutant
Impact List	unknown
Protein Effect	unknown
Gene Variant Descriptions	IDH1 mutant indicates an unspecified mutation in the IDH1 gene.
Associated Drug Resistance
Category Variants Paths	IDH1 mutant

IDH1 mutant - Gene Variant Detail

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