Targeted Therapy
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer.
Read MoreFIRST-308
This is a randomized study to compare the effectiveness of tinengotinib against standard of care chemotherapy in patients who have received prior chemotherapy and one prior FGFR inhibitor (third line of treatment). Tinengotinib is an FGFR inhibitor, which is taken orally once a day. The control arm will be chemotherapy chosen by your physician.
Read MoreSafety and Tolerability of TNG462 in Patients with MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally.
Read MoreSafety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip Code 78229 Country United States List additional…
Read Morephase 2 basket trial of ulixertinib (BVD-523) in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations (BVD-523-HCQ)
This is an open-label, multicenter, phase II basket study of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring MAPK pathway mutations. The trial will have five baskets based on disease primary: cholangiocarcinoma, pancreatic, colorectal, esophageal, and gastric adenocarcinomas.
Read MoreBrightline-2
This study is open to adults with advanced cancer in the biliary tract or pancreas in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile.
Read MoreA Study to Evaluate KIN-3248 (study drug) in Patients with Advanced Tumors Who Have FGFR2 and//or FGFR3 Gene Alterations
This is an open label study in adults with advanced tumors who have FGFR2 and/or FGFR3 mutations. Participants receive daily medicine by mouth of KIN-3248 (study drug) with periodic study visits (ranging from weekly at the beginning of the trial to monthly) to have laboratory testing, imaging assessments and safety exams such as ECG, physical exam
Read MoreA Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients with Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
The study drug, ENV-101, acts on a protein in the body that is thought to be involved with the
growth of these abnormal cells caused by a mutation of a gene, PTCH1. By blocking this
process, ENV-101 may slow the progress of the disease or you may have a partial or complete
response.
ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer
To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy regimens in gastrointestinal cancers, including biliary tract cancer (BTC) such as intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
Read MoreSafety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors
Study Name Safety and Tolerability of TNG908 in Patients with MTAP-deleted Solid Tumors ClinicalTrials.gov Identifier (if applicable) NCT05275478 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name NEXT Oncology Institution Address 2829 Babcock Road City San Antonio State Texas Zip…
Read MoreExpanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
This EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.
Read MoreBasket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual. The solid tumors studied in this trial have either spread to other parts of the body or cannot be removed completely with surgery.
The trial will also look at what side effects happen
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
Read MoreICP-CL-00303
ICP-192 is a novel, irreversible pan-FGFR inhibitor may overcome on-target resistance to first generation FGFR inhibitors (erdafitinib, pemigatinib, rogaratinib, infigratinib, derazatinib). ICP-192 is a highly selective pan-FGFR inhibitor, and has improved safety profiles in comparison to the first generation FGFR inhibitors.
Read MorePhase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC)
Study Name Phase II Study of combination of Trametinib (MEK inhibitor) and Hydroxychloroquine (HCQ) (autophagy inhibitor) in Patients with KRAS Mutation Refractory Bile Tract Carcinoma (BTC). ClinicalTrials.gov Identifier (if applicable) NCT04566133 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name National Cancer Institute Institution Address 10 Center…
Read MoreIvosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
We have identified IDH1 mutations as mediating the exclusion of immune cells in tumors. Ivosidenib is an IDH1 inhibitor. We hypothesize that blocking IDH1 will enhance cancer immunotherapy (nivolumab) in settings where immunotherapy normally doesn’t work. Approximately 10-15% of patients with cholangiocarcinomas have tumors with IDH1 mutations.
Read MoreCRESTONE: Clinical study of response to seribantumab in tumors with neuregulin-1 (NRG1) fusions—A phase II study of the anti-HER3 mAb for advanced or metastatic solid tumors (NCT04383210)
CRESTONE is an open label, multicenter ph 2 trial of seribantumab in adult patients with NRG1 fusion-positive locally advanced or metastatic solid tumors who have progressed on or are nonresponsive to treatment. The trial will enroll previously treated patients across three cohorts no matter what prior treatments have been received.
Read MoreCAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
This is a Phase 1 clinical trial using modified macrophages obtained via apheresis, given intravenously without preparative chemotherapy, for patients with advanced HER2 over expressing solid tumors including cholangiocarcinoma.
Read MoreA Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients with Advanced Biliary Tract Cancer (BTC)
Study Name A Single Arm Phase II Study of the Combination of DKN-01 and Nivolumab in ClinicalTrials.gov Identifier (if applicable) NCT04057365 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Immunotherapy Study Center Institution Name Massachusetts General Hospital Cancer Center Institution Address 55 Fruit St City Boston State Massachusetts Zip Code…
Read MorePROOF Trial: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
The PROOF Trial is a global Phase 3 study enrolling patients with advanced/metastatic cholangiocarcinoma who have a FGFR2 gene fusion/translocation. Patients must not have received systemic anti-cancer treatment for advanced disease. Patients are randomized to receive either oral infigratinib (BGJ398) or standard chemotherapy (gem/cis).
Read MoreStudy of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies. Patients must have documented HER2 expression or amplification. The patient must have exhausted available standard therapies. Cycles will continue until disease progression or unacceptable toxicity.
Read MoreStudy of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3
This phase 2 study will enroll patients of all tumor types including cholangiocarcinomas who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the cholangiocarcinoma to grow. The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions
Read More