Clinical trials: sponsored by Daiichi Sankyo
Renal Cell Carcinoma, Ovarian Tumor
A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors
This clinical trial will evaluate raludotatug deruxtecan (R-DXd; DS-6000a) in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC).
- Trial name
- NCT04707248
- Testing
- DS-6000a
- Where
- 13 sites in United States, Japan
- Volunteers
- 179 people
- Sponsor
- Daiichi Sankyo
Solid Tumors, Sarcoma
First-in-Human Trial of DS-2243a in Participants With Advanced Solid Tumors
This 2-part study will evaluate safety, tolerability, and clinical efficacy of DS-2243a as a treatment for participants with advanced solid tumors.
- Trial name
- NCT06644755
- Testing
- DS-2243a
- Where
- 7 sites in United States, Belgium and 3 more
- Volunteers
- 150 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumor
A Study of DS5361b in Participants With Advanced Solid Tumors
This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
- Trial name
- NCT07182591
- Testing
- DS5361b, Pembrolizumab
- Where
- 7 sites in United States, Japan
- Volunteers
- 192 people
- Sponsor
- Daiichi Sankyo
Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer
First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study.
- Conditions
- Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT03401385
- Testing
- Datopotamab Deruxtecan (Dato-DXd), Steroid Containing Mouthwash, Non-Steroid Containing Mouthwash
- Where
- 18 sites in United States, Japan
- Volunteers
- 890 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and…
- Trial name
- NCT04619004
- Testing
- Patritumab Deruxtecan (Fixed dose), Patritumab Deruxtecan (Up-Titration)
- Where
- 123 sites in United States, Australia and 14 more
- Volunteers
- 277 people
- Sponsor
- Daiichi Sankyo
Fallopian Tube Cancer, Primary Peritoneal Cancer
A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03)
The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as…
- Conditions
- Fallopian Tube Cancer, Primary Peritoneal Cancer, High-Grade Serous Ovarian Cancer, Endometrioid Epithelial Ovarian
- Trial name
- NCT07791732
- Testing
- R-DXd, Bevacizumab
- Volunteers
- 600 people
- Sponsor
- Daiichi Sankyo
Nonsquamous Non-small Cell Lung Cancer, EGFR L858R
HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy
Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.
- Conditions
- Nonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion
- Trial name
- NCT05338970
- Testing
- Patritumab Deruxtecan, Platinum-based chemotherapy
- Where
- 182 sites in United States, Australia and 19 more
- Volunteers
- 586 people
- Sponsor
- Daiichi Sankyo
Non-small Cell Lung Cancer
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic…
- Trial name
- NCT04656652
- Testing
- DS-1062a, Docetaxel
- Where
- 209 sites in United States, Argentina and 24 more
- Volunteers
- 605 people
- Sponsor
- Daiichi Sankyo
Hematological Malignancies, B-cell Non-Hodgkin Lymphoma
A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.
- Trial name
- NCT07220616
- Testing
- DS3790a, Combination drug
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 420 people
- Sponsor
- Daiichi Sankyo
Urothelial Cancer, Bladder Cancer
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus…
- Trial name
- NCT07129993
- Testing
- Dato-DXd, Carboplatin, Cisplatin
- Where
- 100 sites in United States, Austria and 5 more
- Volunteers
- 630 people
- Sponsor
- Daiichi Sankyo
HER2-positive Advanced Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)
Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior…
- Trial name
- NCT05993234
- Testing
- Trastuzumab deruxtecan
- Where
- 39 sites in Austria, Belgium and 2 more
- Volunteers
- 257 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Unresectable Breast Cancer, Metastatic Breast Cancer
DESTINY Breast Respond HER2-(Ultra)Low Europe
Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer
- Trial name
- NCT05945732
- Testing
- Trastuzumab deruxtecan
- Where
- 216 sites in Austria, Belgium and 8 more
- Volunteers
- 2,295 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Non-small Cell Lung Cancer
Clinical Effectiveness and Safety of Trastuzumab Deruxtecan (T-DXd) in Chinese Patients With HER2m NSCLC (RERUN)
Trastuzumab deruxtecan (T-DXd) is an approved therapy for non-small cell lung cancer (NSCLC) in China. Despite the clinical trial evidence, there is no real-world data of T-DXd used in Chinese lung cancer patients with HER2…
- Trial name
- RERUN (NCT06809764)
- Testing
- No drug
- Where
- 36 sites in China
- Volunteers
- 150 people
- Sponsor
- Daiichi Sankyo
HER2-positive Gastric Cancer, HER2-positive Gastroesophageal Junction
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China
Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients.
- Trial name
- RECOVER (NCT06846996)
- Testing
- Trastuzumab deruxtecan (T-DXd)
- Where
- 40 sites in China
- Volunteers
- 260 people
- Sponsor
- Daiichi Sankyo
Gastric Cancer, Gastroesophageal Junction Cancer
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC)…
- Trial name
- NCT06731478
- Testing
- Trastuzumab Deruxtecan, pembrolizumab, Trastuzumab
- Where
- 250 sites in United States, Argentina and 24 more
- Volunteers
- 726 people
- Sponsor
- Daiichi Sankyo
Small Cell Lung Cancer
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
This study is designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
- Trial name
- IDeate-Lung02 (NCT06203210)
- Testing
- Ifinatamab deruxtecan, Topotecan, Amrubicin
- Where
- 229 sites in United States, Australia and 21 more
- Volunteers
- 540 people
- Sponsor
- Daiichi Sankyo
Glioma
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas
This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.
- Trial name
- NCT03030066
- Testing
- DS-1001b
- Where
- Japan
- Volunteers
- 47 people
- Sponsor
- Daiichi Sankyo
Non-small Cell Lung Cancer, Lung Cancer
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations
This study will compare Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in First-line NSCLC Without Actionable Genomic Alterations
- Trial name
- NCT06644768
- Testing
- valemetostat tosylate, pembrolizumab
- Where
- 35 sites in United States, Argentina and 3 more
- Volunteers
- 137 people
- Sponsor
- Daiichi Sankyo
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.
- Trial name
- NCT04703192
- Testing
- Valemetostat Tosylate
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 155 people
- Sponsor
- Daiichi Sankyo
Recurrent or Metastatic Solid Tumors
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.
- Trial name
- NCT07015697
- Testing
- Trastuzumab Deruxtecan
- Where
- 31 sites in United States, Brazil and 5 more
- Volunteers
- 76 people
- Sponsor
- Daiichi Sankyo