A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors | The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine. | Soft tissue sarcoma: -Leiomyosarcoma
-Liposarcoma
-Undifferentiated Pleomorphic Sarcoma (UPS; covering malignant fibrous histiocytoma)
-Synovial sarcoma.
Bone sarcoma:
-Ewing's sarcoma (including extraskeletal)
-Osteosarcoma
-Chondrosarcoma
Other Cancer Types:
-NSCLC
-Solid tumors
| -Sarcoma indications (including those listed for combination therapy arms) regardless of AXL gene amplification status.
-NSCLC regardless of AXL gene amplification status.
-Solid tumors (lymphomas participants are excluded) with known AXL gene amplification.
| NCT05389462 | Recruiting Patients |
A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors | -Part 1 is the dose escalation of APG-115 in combination with label dose of pembrolizumab.
-Part 2 is phase II design of APG-115 at recommended phase 2 dose (RP2D) in combination with pembrolizumab. | -MPNST (Malignant Peripheral Nerve Sheath Tumor)
-Uveal Melanoma
-Melanoma
| -Unresectable/metastatic MPNST (12 years of age or greater)
-Uveal Melanoma
-Unresectable/metastatic melanoma refractory or relapse after PD-1 antibody treatment and ineligible for other standard of care therapy | NCT03611868 | Recruiting Patients |
Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), in Subjects With Tumors With Oncogene Amplifications (POTENTIATE) | BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies. | -Liposarcoma
-Non-small Cell Lung Cancer
-Non-Small Cell Lung Adenocarcinoma
-Non-Small Cell Squamous Lung Cancer
-Head and Neck Squamous Cell -Carcinoma
-Esophageal Cancer
-Gastric Cancer
-Breast Cancer
-Bladder Cancer
-Ovarian Cancer
-Endometrial Cancer
| -Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists
-Evidence of an oncogene amplification
-Evidence of amplification of wildtype EGFR
-Evidence of amplification of wildtype FGFR1, FGFR2, FGFR3, or FGFR4
| NCT05827614 | Recruiting Patients |
Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications (STARMAP) | BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies. | -locally advanced or metastatic non-resectable solid tumors | Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies | NCT06299761 | Recruiting Patients |
A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 (Brigimadlin) in Patients With Advanced or Metastatic Solid Tumors | This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. | -Liposarcoma
-Sarcoma
-Non-Small Cell Carcinoma of the Lung
-Urothelial Carcinoma
-Biliary carcinoma (including cholangiocarcinoma and gallbladder cancer)
-Pancreatic adenocarcinoma
| -Patients with MDM2 amplified sarcomas who require first line treatment (for Ph Ib/dose expansion - Cohort 1 only).
-Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry.
-TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any line of therapy.
-TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract (including cholangiocarcinoma, intra- and extrahepatic biliary tree, gallbladder and ampulla of vater) or pancreatic solid PDAC tumors who have had at least one previous line of therapy for advanced/metastatic disease.
| NCT03449381 | Recruiting Patients |
A Phase Ia/Ib, Open Label, Dose-escalation Study of the Combination of BI 907828 (Brigimadlin) With BI 754091 (Ezabenlimab) and BI 754111 and the Combination of BI 907828 (Brigimadlin) With BI 754091(Ezabenlimab) Followed by Expansion Cohorts, in Patients With Advanced Solid Tumors
| The participants get a combination of 2 medicines called brigimadlin (also called BI 907828) and ezabenlimab (also called BI 754091). Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor). | -unresectable, advanced and/or metastatic solid tumors | -unresectable, advanced and/or metastatic solid tumors | NCT03964233 | Recruiting Patients |
Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma | This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumors are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. | -Progressive or recurrent Dedifferentiated liposarcoma (DDLPS) | -DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridisation (FISH) or next-generation sequencing (NGS) | NCT06058793 | Recruiting Patients |
A Phase 1/1b, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors | DF6215-001 is a study of a modified human cytokine (interleukin-2; IL-2) that retains the ability to bind to a certain part of the IL-2 receptor on a subset of white blood cells (lymphocytes), which can help recognize and kill tumor cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors. The second phase, Phase 1b, will include a dose expansion using the best dose selected from the first phase of the study. A cohort will be opened with eligible patients having a select solid tumor. | -locally advanced or metastatic solid tumor
-Melanoma
-HPV-positive advanced malignancies
-Ovarian cancer
-Head and neck cancer
-Lung cancer (non-small-cell lung cancer [NSCLC])
-Renal cell carcinoma (RCC)
| -locally advanced or metastatic solid tumor, for which no standard therapy exists, or standard therapy has failed | NCT06108479 | Recruiting Patients |
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors | A Phase 1/2a, Open-Label, Multicenter, Nonrandomized, Safety and Anti-tumor Activity Study of IMM-1-104, a Novel Oral Dual MEK1/2 Inhibitor in Participants With Previously Treated RAS-Mutated Advanced or Metastatic Solid Tumors |
-Pancreatic adenocarcinoma (PDAC)
-Non-small cell lung carcinoma (NSCLC)
-Melanoma
| -A locally advanced unresectable or metastatic solid tumor malignancy that harbors a RAS (KRAS, NRAS, or HRAS) activating mutation.
–A locally advanced unresectable or metastatic solid tumor malignancies: pancreatic ductal adenocarcinoma (PDAC), RAS-mutant melanoma, or RAS-mutant non-small cell lung cancer (NSCLC)
-Combination therapy (both phases): A locally advanced unresectable or metastatic PDAC
| NCT05585320 | Recruiting Patients |
A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) | To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.
|
-Liposarcoma (dedifferentiated, myxoid, round cell or pleomorphic),
-Leiomyosarcoma (non-uterine)
-Undifferentiated pleomorphic sarcoma.
| -1 line of therapy for a soft tissue sarcoma and must have progressed following anthracycline-based or alternative standard therapies, except if medically contraindicated or refused by participant | NCT06263231 | Recruiting Patients |
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors | This is a Phase 1/2, open-label, non-randomized, 4-part Phase 1 trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda). | -Locally advanced or metastatic non resectable solid tumors
-Non-Small Cell Lung Cancer (NSCLC)
-Melanoma
-Head/Neck Squamous cell carcinoma
-Gastric carcinoma
-Gastroesophageal carcinoma
-Renal Cell Carcinoma
-Urothelial/transitional carcinoma
| -Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists. | NCT04198766 | Recruiting Patients |
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) | The primary objective of this phase IIb/III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent. | Leiomyosarcoma | Leiomyosarcoma with no previous systemic therapy for metastatic disease (i.e., first-line setting) and no previous anthracyclines. Note: prior chemotherapy (without anthracycline) in the context of adjuvant or neoadjuvant therapy is allowed. | NCT06088290 | Recruiting Patients |
Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors | A Phase 1, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-1010 (IL12-FHAB) in Adult Patients With Advanced Solid Tumors. | -Advanced Solid tumors (carcinomas and sarcomas) | Patients with advanced solid tumors who have been treated with standard of care therapies for their disease and have no standard alternative treatment options | NCT05352750 | Recruiting Patients |
SAINT:Trabectedin, Ipilimumab and Nivolumab as First Line Treatment for Advanced Soft Tissue Sarcoma | This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study, previously untreated patients will be enrolled. | locally advanced unresectable or metastatic soft tissue sarcoma (STS) | Patients with locally advanced, unresectable or metastatic soft tissue sarcoma who have not previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 antibody | NCT03138161 | Recruiting Patients |
Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma (TNT) | This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma. |
-Advanced sarcoma -Desmoid tumor -Chordoma. | Patients with locally advanced unresectable or metastatic sarcoma including desmoid tumor and chordoma that are previously untreated or treated patients with measurable disease and at least, one accessible tumor for intratumoral injection of TALIMOGENE LAHERPAREPVEC | NCT03886311 | Recruiting Patients |
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma | This is an open label phase 2 study for advanced sarcoma using metronomic doses of gemcitabine, doxorubicin and docetaxel, and nivolumab immunotherapy given intravenously. | locally advanced, unresectable or metastatic sarcoma
| Previously treated patient with locally advanced, unresectable or metastatic sarcoma with measurable disease | NCT04535713 | Recruiting Patients |
LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma | This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously. | locally advanced unresectable or metastatic soft tissue sarcoma | -Patients with locally advanced unresectable or metastatic soft tissue sarcoma | NCT05876715 | Recruiting Patients |
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1) | Study TSC-007 is a prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety profile of nab-sirolimus administered to patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. Patients will be treated with single agent IV nab-sirolimus until disease progression, or unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at patient discretion.
| -Malignant solid tumor with a pathogenic inactivating TSC1 or TSC2 alteration | -Patients with solid tumors with a pathogenic inactivating TSC1 or TSC2 alteration. Genetic alterations should be identified using NGS in tumor tissue or liquid biopsy | NCT05103358 | Recruiting Patients |
Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer | This is a Phase 1b/2a, open-label, adaptive-design outpatient study to assess the safety, tolerability, and PK/PD of SON-1010 in combination with atezolizumab administered to patients with advanced solid tumors (Part 1) and patients with Platinum-resistant Ovarian Cancer |
-locally advanced or metastatic solid tumor
-Metastatic/recurrent platinum resistant ovarian cancer (PROC) (including epithelial, fallopian tube, or 1° peritoneal carcinoma)
| -Patients with Metastatic/recurrent platinum resistant ovarian cancer (defined as recurrence of OC within 6-months (180-days) after the last dose of a platinum-containing regimen), including epithelial, fallopian tube, or 1° peritoneal carcinoma) | NCT05756907 | Recruiting Patients |
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen (CHONQUER) | Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants.
Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
|
-Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation
| Patients with untreated or Previously Treated Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation With 1 Systemic Treatment Regimen | NCT06127407 | Recruiting Patients |