Clinical trials: Hormone-Resistant Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated…
- Trial name
- reaINAVO (NCT07347600)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 32 sites in China
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Non Small Cell Lung Cancer, Cervical Cancer
Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with…
- Conditions
- Non Small Cell Lung Cancer, Cervical Cancer, SCCHN, Pancreatic Cancer
- Trial name
- NCT04925284
- Testing
- XB002, Nivolumab, Bevacizumab
- Where
- 95 sites in United States, Australia and 7 more
- Volunteers
- 269 people
- Sponsor
- Exelixis
Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)
- Trial name
- ELUCIDATE (NCT05985655)
- Testing
- GTAEXS617, SoC
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 230 people
- Sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Cervical Cancer, Breast Cancer
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or…
- Conditions
- Cervical Cancer, Breast Cancer, Colon Cancer, NSCLC
- Trial name
- NCT05283330
- Testing
- ²¹²Pb-DOTAM-GRPR1
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Orano Med Theranostics, SAS
Solid Tumor, Solid Tumor, Adult
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of…
- Conditions
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor
- Trial name
- NCT06264921
- Testing
- NKT3447
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- NiKang Therapeutics, Inc.
Breast Cancer
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with…
- Trial name
- NCT07405801
- Testing
- Inavolisib, Ribociclib, Fulvestrant
- Where
- 58 sites in United States, Argentina and 10 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
Solid Tumors, Advanced Triple Negative Breast Cancer
A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors
This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases: Phase 1b Dose Escalation Part 1 (Doublet Therapy) Dose Escalation Part 2 (Triplet Therapy) Phase 2a Dose Expansion (Triplet…
- Conditions
- Solid Tumors, Advanced Triple Negative Breast Cancer, Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer, Advanced Metastatic Castration-Resistant Prostate Cancer
- Trial name
- NCT03861403
- Testing
- TRX518, Cyclophosphamide, Avelumab
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Leap Therapeutics, Inc.
Neoplasm Malignant, Renal Cell Carcinoma
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination…
- Conditions
- Neoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Castration-resistant Prostate Cancer
- Trial name
- STELLAR-001 (NCT03845166)
- Testing
- XL092, Atezolizumab, Avelumab
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 325 people
- Sponsor
- Exelixis
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Breast Cancer
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative…
- Trial name
- NCT06702618
- Testing
- TQB3616 capsule+Fulvestrant Injection
- Where
- 13 sites in China
- Volunteers
- 33 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Trial name
- NCT07570966
- Testing
- ERW316, Fulvestrant, Letrozole
- Sponsor
- Novartis Pharmaceuticals
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.
- Conditions
- High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Trial name
- RAINFOL-01 (NCT05579366)
- Testing
- Rina-S, Carboplatin, Bevacizumab
- Where
- 66 sites in United States, China and 1 more
- Volunteers
- 952 people
- Sponsor
- Genmab
Triple Negative Breast Cancer, Hormone-Resistant Breast Cancer
First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies
This is a first in human phase 1 study of AG01 an anti-Progranulin/Glycoprotein88 (PGRN/GP88) antibody in patients with advanced solid tumors. AG01 is a recombinant monoclonal antibody expressed in a CHO production cell line.
- Conditions
- Triple Negative Breast Cancer, Hormone-Resistant Breast Cancer, Non Small Cell Lung Cancer, Mesothelioma
- Trial name
- NCT05627960
- Testing
- AG-01 Compound
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- A&G Pharmaceutical Inc.
Advanced Cancer
Safety and Tolerability of Different Dose Combinations of Ridaforolimus With MK-2206 or MK-0752 for Participants With Advanced Cancer (MK-8669-049)
This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752. In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug combinations will be found by giving sequentially higher…
- Trial name
- NCT01295632
- Testing
- ridaforolimus, MK-0752, MK-2206
- Volunteers
- 65 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who…
- Trial name
- NCT01225172
- Testing
- BMS-754807, letrozole
- Where
- 21 sites in United States
- Volunteers
- 77 people
- Sponsor
- Bristol-Myers Squibb
Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer
Study of 68Ga-R10602
A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.
- Conditions
- Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer, Hormone Receptor Positive Breast Adenocarcinoma
- Trial name
- NCT06745804
- Testing
- 68Ga-R10602 injection
- Where
- 6 sites in United States
- Volunteers
- 27 people
- Sponsor
- Radionetics Oncology
Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to…
- Conditions
- Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers, Esophageal Squamous Cell Carcinoma
- Trial name
- NCT06084481
- Testing
- ABBV-400, Itraconazole (ITZ), Bevacizumab
- Where
- 54 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- AbbVie
Neoplasm Malignant, Epithelial Ovarian Cancer
Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101)
This is a Phase 1, open-label, dose-escalation and expansion study evaluating the safety, tolerability, PK, antitumor activity, and effect on biomarkers of XL102 administered orally alone and in multiple combination regimens to…
- Conditions
- Neoplasm Malignant, Epithelial Ovarian Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- NCT04726332
- Testing
- XL102, Fulvestrant, Abiraterone
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Exelixis