Clinical trials: Select Advanced Malignancies
Triple Negative Breast Cancer (TNBC)
Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC).
This is a Phase Ib, open label, dose escalation study of spartalizumab + LAG525 in combination with NIR178, capmatinib, MCS110, or canakinumab, followed by a dose expansion in adult patients with advanced or metastatic TNBC.
- Trial name
- NCT03742349
- Testing
- spartalizumab, LAG525, NIR178
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 64 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, Adult, Breast Cancer
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced…
- Conditions
- Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer
- Trial name
- NCT03149549
- Testing
- CX-2009
- Where
- 26 sites in United States, Netherlands and 2 more
- Volunteers
- 99 people
- Sponsor
- CytomX Therapeutics
Cancer, HLA-A*02:01-positive
Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A*02:01-positive participants…
- Trial name
- NCT06840119
- Testing
- IMC-R117C, Chemotherapy drug, Kinase inhibitor
- Where
- 13 sites in Australia, Belgium and 4 more
- Volunteers
- 600 people
- Sponsor
- Immunocore Ltd
Solid Tumors
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in participants with selected tumor indications.
- Trial name
- NCT01772004
- Testing
- Avelumab
- Where
- 74 sites in United States, Belgium and 7 more
- Volunteers
- 1,756 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
ER+ Breast Cancer, Ovarian Cancer
Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumor, Including a Cohort Expansion in Esophageal Cancer.
This Phase 1b is a dose escalation, MTD expansion and cohort expansions study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.
- Conditions
- ER+ Breast Cancer, Ovarian Cancer, Cervical Squamous Cell Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT03983954
- Testing
- Obinutuzumab, naptumomab estafenatox and durvalumab, Naptumomab estafenatox and durvalumab
- Where
- 9 sites in India, Israel
- Volunteers
- 120 people
- Sponsor
- NeoTX Therapeutics Ltd.
Locally Advanced or Metastatic Breast Cancer
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or…
- Trial name
- NCT06680921
- Testing
- SIM0270, Everolimus (Afinitor®), Exemestane tablets
- Where
- 57 sites in China
- Volunteers
- 482 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Neoplasms
Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology.
- Trial name
- NCT02723955
- Testing
- feladilimab (GSK3359609), GSK3174998, Pembrolizumab
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 829 people
- Sponsor
- GlaxoSmithKline
Oncology, Solid Tumors
Study of Avelumab-M3814 Combinations
The main purpose of the study was to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in…
- Trial name
- NCT03724890
- Testing
- M3814, Avelumab, Radiotherapy
- Where
- 8 sites in United States
- Volunteers
- 57 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Carcinoma
Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications
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).
- Conditions
- Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Carcinoma, High Grade Endometrial Carcinoma, Anogenital Cancer
- Trial name
- POTENTIATE (NCT05827614)
- Testing
- BBI-355, Erlotinib, Futibatinib
- Where
- 16 sites in United States
- Volunteers
- 85 people
- Sponsor
- Boundless Bio, Inc.
Biliary Tract Cancer
A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after…
- Trial name
- NCT07606599
- Testing
- BL-M07D1, Oxaliplatin, Calcium levofolinate
- Where
- 2 sites in China
- Volunteers
- 398 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Advanced Solid Tumors, Selected Solid Tumors
Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients
This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor…
- Trial name
- NCT01363232
- Testing
- BKM120 + MEK162
- Where
- 12 sites in United States, Canada and 5 more
- Volunteers
- 89 people
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Urothelial Carcinoma
SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants…
- Trial name
- NCT07526792
- Testing
- SYS6002, Investigator's Choice of Chemotherapy
- Volunteers
- 406 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Salivary Gland Tumor, Urothelial Carcinoma
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that…
- Conditions
- Salivary Gland Tumor, Urothelial Carcinoma, Ovarian Carcinoma, Breast Cancer
- Trial name
- NCT04969835
- Testing
- AVA6000
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 158 people
- Sponsor
- Avacta Life Sciences Ltd
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Solid Tumor (Phase I)
This Clinical Study is to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of BD200 in Participants With Advanced or Metastatic Cancer.
The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers.
- Trial name
- NCT07797907
- Testing
- BD200
- Volunteers
- 110 people
- Sponsor
- Biolojic Design Ltd.
Advanced Solid Tumor, CNS Tumor
Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations
The phase 1b study is aimed at determining the pediatric recommended phase 2 dose (RP2D) of Infigratinib. The phase 2 study will evaluate efficacy and safety of infigratinib.
- Conditions
- Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma
- Trial name
- NEWEL (NCT05222165)
- Testing
- Infigratinib
- Where
- 10 sites in United States, Canada and 1 more
- Sponsor
- Helsinn Healthcare SA
Melanoma, Cervical Carcinoma
A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors
This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess…
- Conditions
- Melanoma, Cervical Carcinoma, Pancreatic Carcinoma, Triple Negative Breast Cancer
- Trial name
- DUET-4 (NCT03849469)
- Testing
- XmAb®22841, Pembrolizumab (Keytruda®)
- Where
- 28 sites in United States
- Volunteers
- 78 people
- Sponsor
- Xencor, Inc.
NSCLC (Advanced Non-small Cell Lung Cancer)
Global, Multicenter Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
This clinical trial consists of two parts: phase 2 and phase 3. The goal of phase 2 of this clinical trial is to compare which dose level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype…
- Trial name
- NCT07718737
- Testing
- AMT-116, Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)
- Where
- 7 sites in United States, Australia
- Volunteers
- 512 people
- Sponsor
- Multitude Therapeutics Inc.
Advanced Solid Tumors
Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II.
- Trial name
- NCT04856774
- Testing
- SHR-1701;BP102
- Where
- China
- Volunteers
- 81 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Solid Tumors
Study of INCB123667 in Subjects With Advanced Solid Tumors
This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with…
- Trial name
- NCT05238922
- Testing
- INCB0123667, Palbociclib, Bevacizumab
- Where
- 41 sites in United States, France and 6 more
- Volunteers
- 291 people
- Sponsor
- Incyte Corporation