A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
NCT05975073 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2026-04-22
Summary
The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of Anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
Conditions
- MTAP-null Non-Small-Cell Lung Cancer
- MTAP-null Solid Tumors
Interventions
- DRUG
-
Anvumetostat
Administered PO
- DRUG
-
Administered PO
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2026-02-25
- Completion
- 2026-03-26
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Denmark
- South Korea
- Spain
- Taiwan
Study Locations
More Related Trials
-
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
NCT06131398 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study Evaluating AMG 706 in Subjects With Advanced Solid Tumors
NCT00093873 ·Status: COMPLETED ·Phase: PHASE1
-
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
NCT04362748 ·Status: COMPLETED ·Phase: PHASE1
-
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
NCT04727554 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1b, Open-label, Dose-finding Study of AMG 706 in Combination With Gemcitabine and Erlotinib to Treat Subjects With Solid Tumors
NCT01235416 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications
NCT05317078 ·Status: TERMINATED ·Phase: PHASE1
-
Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors
NCT01122199 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of AMG 337 in Subjects With Advanced Solid Tumors
NCT01253707 ·Status: COMPLETED ·Phase: PHASE1
-
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
NCT04794699 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of AMG 650 in Adult Participants With Advanced Solid Tumors
NCT04293094 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of AMG 208 in Subjects With Advanced Solid Tumors
NCT00813384 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
NCT05389462 ·Status: TERMINATED ·Phase: PHASE1
-
The Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
NCT03507543 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors
NCT00811993 ·Status: TERMINATED ·Phase: PHASE1
-
QUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid Tumors
NCT00974896 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)
NCT05594043 ·Status: COMPLETED ·Phase: PHASE1
-
IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
NCT04434482 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
NCT01331941 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
NCT00858377 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of FDA018-ADC in Patients With Advanced Solid Tumors
NCT05174637 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Tolerability of TNG908 in Patients With MTAP-deleted Solid Tumors
NCT05275478 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
NCT07094113 ·Status: RECRUITING ·Phase: PHASE1
-
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
NCT05098132 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
AMG 172 First in Human Study in Patients With Kidney Cancer
NCT01497821 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
NCT00102830 ·Status: COMPLETED ·Phase: PHASE1