Clinical trials: Cancer Gene Mutation
Low-grade NMIBC, FGFR Gene Amplification
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Conditions
- Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration
- Trial name
- SURF302 (NCT06995677)
- Testing
- TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Tyra Biosciences, Inc
Metastatic Hepatocellular Carcinoma, Solid Tumors
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF/FGFR pathway aberrations, including locally advanced/metastatic…
- Conditions
- Metastatic Hepatocellular Carcinoma, Solid Tumors, Solid Tumor, Adult, FGFR Gene Amplification
- Trial name
- SURF431 (NCT06915753)
- Testing
- TYRA-430
- Where
- 16 sites in United States, Canada and 2 more
- Volunteers
- 125 people
- Sponsor
- Tyra Biosciences, Inc
Epidermal Growth Factor, Epidermal Growth Factor Receptor
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any…
- Conditions
- Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell
- Trial name
- NCT07462377
- Testing
- EPI-326
- Where
- 8 sites in United States, South Korea and 1 more
- Volunteers
- 110 people
- Sponsor
- EpiBiologics
Breast Neoplasms, Solid Tumors
A Phase 1/2a Study of K-1728 in Advanced Solid Tumors
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors.
- Conditions
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- Trial name
- PIKYMA-01 (NCT07861932)
- Testing
- K-1728, Fulvestrant, Palbociclib
- Volunteers
- 110 people
- Sponsor
- KymaThera, Inc.
Desmoid Tumor, NOTCH Gene Mutation Positive Tumors
Individual Patient Compassionate Use of Nirogacestat
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.
- Trial name
- NCT05041036
- Testing
- Nirogacestat (Gamma Secretase Inhibitor)
- Where
- 2 sites in United States, Germany
- Sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
HER2 Gene Mutation, Advanced Solid Tumors
HEAT Trial (HER2 Antibody Therapy With Lutetium-177)
This is a first-in-human, Phase 0/1, open-label study of177Lu-RAD202 to determine the recommended dose(s) for future exploration of 177Lu-RAD202 in participants with HER2 expressing advanced solid tumours.
- Trial name
- RAD202 (NCT06824155)
- Testing
- 177Lu-RAD202
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Advanced Solid Tumor, Metastatic Solid Tumor
Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
This is a first-in-human, multicenter, open-label, phase 1 study to evaluate safety, tolerability, and efficacy of CID-078, a Cyclin A/B-RxL inhibitor, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Refractory Solid Tumor, Cancer
- Trial name
- NCT06577987
- Testing
- CID-078 Monotherapy
- Where
- 10 sites in United States
- Volunteers
- 220 people
- Sponsor
- Circle Pharma
Advanced Solid Tumor, Ovarian Cancer
A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer
The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800. In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and…
- Conditions
- Advanced Solid Tumor, Ovarian Cancer, Ovarian Clear Cell Carcinoma, Ovarian Clear Cell Tumor
- Trial name
- NCT05226507
- Testing
- NXP800
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Nuvectis Pharma, Inc.
Advanced Cancer, Breast Cancer
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination…
- Conditions
- Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation
- Trial name
- PIKture-01 (NCT06239467)
- Testing
- OKI-219, Fulvestrant, Trastuzumab
- Where
- 33 sites in United States, Belgium and 4 more
- Volunteers
- 200 people
- Sponsor
- OnKure, Inc.
Pancreatic Cancer, Small Bowel Cancer
Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF…
- Conditions
- Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer, Melanoma
- Trial name
- NCT04566393
- Testing
- Ulixertinib (BVD-523)
- Where
- 26 sites in United States
- Sponsor
- xCures
Advanced Solid Tumor, Metastatic Solid Tumor
Study of LP-184 in Patients With Advanced Solid Tumors
The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, GBM, TNBC - Triple-Negative Breast Cancer
- Trial name
- NCT05933265
- Testing
- LP-184, Olaparib, Nivolumab & Ipilimumab
- Where
- 7 sites in United States
- Volunteers
- 64 people
- Sponsor
- Lantern Pharma Inc.
Oncology, MEK Mutation
A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors
This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway…
- Conditions
- Oncology, MEK Mutation, RAF Gene Mutation, Ras (KRAS or NRAS) Gene Mutation
- Trial name
- NST-628 (NCT06326411)
- Testing
- NST-628
- Where
- 23 sites in United States, Australia
- Volunteers
- 230 people
- Sponsor
- Nested Therapeutics, Inc
Solid Tumors, Homologous Recombination Repair Gene Mutation
Basket Trial of IDX-1197, a PARP Inhibitor, in Patients With HRR Mutated Solid Tumors (VASTUS)
This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation. There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a…
- Conditions
- Solid Tumors, Homologous Recombination Repair Gene Mutation, Homologous Recombination Deficiency
- Trial name
- VASTUS (NCT04174716)
- Testing
- IDX-1197
- Where
- 19 sites in South Korea
- Volunteers
- 108 people
- Sponsor
- Idience Co., Ltd.
VHL - Von Hippel-Lindau Syndrome, VHL Gene Mutation
A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)
This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.
- Conditions
- VHL - Von Hippel-Lindau Syndrome, VHL Gene Mutation, VHL Syndrome, VHL Gene Inactivation
- Trial name
- NCT03401788
- Testing
- Belzutifan
- Where
- 11 sites in United States, Denmark and 2 more
- Volunteers
- 50 people
- Sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
- Conditions
- Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1
- Trial name
- NCT05735184
- Testing
- Ziftomenib, Venetoclax, Azacitidine
- Where
- 44 sites in United States
- Volunteers
- 420 people
- Sponsor
- Kura Oncology, Inc.
Advanced Solid Tumor, RAF Mutation
Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway
This is a multicenter clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors.
- Conditions
- Advanced Solid Tumor, RAF Mutation, RAS Mutation, NF1 Mutation
- Trial name
- NCT06287463
- Testing
- DCC-3084
- Where
- 9 sites in United States
- Volunteers
- 29 people
- Sponsor
- Deciphera Pharmaceuticals, LLC
FGFR2 Amplification, FGFR2 Gene Mutation
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in…
- Conditions
- FGFR2 Amplification, FGFR2 Gene Mutation, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Translocation
- Trial name
- NCT04526106
- Testing
- RLY-4008
- Where
- 48 sites in United States, Australia and 11 more
- Volunteers
- 490 people
- Sponsor
- Elevar Therapeutics
AXIN1 Gene Mutation, APC Gene Mutation
A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation
This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors…
- Conditions
- AXIN1 Gene Mutation, APC Gene Mutation, Solid Tumor
- Trial name
- NCT06005974
- Testing
- REC-4881
- Where
- 13 sites in United States
- Volunteers
- 18 people
- Sponsor
- Recursion Pharmaceuticals Inc.
PDL1 Gene Mutation, Non Small Cell Lung Cancer
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to…
- Conditions
- PDL1 Gene Mutation, Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), TNBC, Triple Negative Breast Cancer
- Trial name
- NCT06305962
- Testing
- 177Lu-RAD204
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Radiopharm Theranostics, Ltd