Clinical trials: Dose Escalation and Safety
Non-small Cell Lung Cancer
Dose Escalation Trial of Bexmarilimab (FP-1305) Plus Pembrolizumab in Non-Small Cell Lung Cancer
This study enrolls patients with Non-small cell lung cancer and treats them with the investigational drug Bexmarilimab (FP-1305) plus standard of care Pembrolizumab to block Common lymphatic endothelial and vascular endothelial…
- Trial name
- NCT05171062
- Testing
- bexmarilimab (FP-1305), Pembrolizumab
- Where
- United States
- Sponsor
- The University of Texas Health Science Center at San Antonio
Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination…
- Conditions
- Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Trial name
- KAT6 (NCT04606446)
- Testing
- PF-07248144, Fulvestrant, Letrozole
- Where
- 43 sites in United States, Australia and 3 more
- Volunteers
- 320 people
- Sponsor
- Pfizer
Neoplasms, Non-small-cell Lung Cancer
A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors
This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or…
- Conditions
- Neoplasms, Non-small-cell Lung Cancer, Melanoma, Squamous Cell Carcinoma of the Head and Neck
- Trial name
- NCT06285097
- Testing
- PF-07820435, Sasanlimab
- Where
- 10 sites in United States, Japan and 1 more
- Volunteers
- 9 people
- Sponsor
- Pfizer
Unspecified Adult Solid Tumor, Protocol Specific
PR104 and G-CSF in Treating Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00616213
- Testing
- filgrastim, PR104, F-18-fluoromisonidazole
- Where
- 3 sites in United States, New Zealand
- Volunteers
- 5 people
- Sponsor
- Proacta, Incorporated
High-grade Glioma
Study of MT027 in Patients with Recurrent or Progressive High-grade Glioma
The clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ cells per dose.
- Trial name
- NCT06737146
- Testing
- MT027 cells suspension
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Suzhou Maximum Bio-tech Co., Ltd.
Breast Cancer
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human…
- Trial name
- NCT06515470
- Testing
- BTX-9341, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 82 people
- Sponsor
- Biotheryx, Inc.
Neoplasms, Malignant
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel and Cisplatin in Patients With Solid Tumors
Primary Objective: To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with docetaxel and cisplatin administered every 3 weeks in…
- Trial name
- NCT01095302
- Testing
- OMBRABULIN (AVE8062), cisplatin, docetaxel
- Where
- 3 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Sanofi
Advanced Malignancy, Advanced Solid Tumors
A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
- Conditions
- Advanced Malignancy, Advanced Solid Tumors, Neoplasm, Metastasis
- Trial name
- SDX-0101 (NCT02743637)
- Testing
- SDX-7320
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- SynDevRx, Inc.
Colorectal Cancer, Ovarian Cancer
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
This is a two-part Phase 1/2 dose escalation and dose expansion study of an Adenovirus Vector (Ad5/3-D24-GMCSF), Expressing GM-CSF (GM-CSF-encoding adenovirus), ONCOS-102, in combination with anti-programmed death ligand-1…
- Conditions
- Colorectal Cancer, Ovarian Cancer, Appendiceal Cancer
- Trial name
- NCT02963831
- Testing
- ONCOS-102, Durvalumab, Cyclophosphamide
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Ludwig Institute for Cancer Research
Solid Tumor
GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies
The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with…
- Trial name
- NCT04937153
- Testing
- Acasunlimab, Pembrolizumab
- Where
- 2 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Genmab
Sickle Cell Disease
A Phase 2 Study of the Effects of 6R-BH4 in Subjects With Sickle Cell Disease
This Phase 2a, multicenter, open-label, dose-escalation study is designed to assess the safety and biologic activity of daily oral administration of 4 escalating doses of sapropterin dihydrochloride over 16 weeks in subjects with…
- Trial name
- NCT00445978
- Testing
- Sapropterin Dihydrochloride
- Where
- 12 sites in United States
- Volunteers
- 32 people
- Sponsor
- BioMarin Pharmaceutical
Melanoma, Head and Neck Cancer
Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck…
- Conditions
- Melanoma, Head and Neck Cancer, Non Small Cell Lung Cancer, Urothelial Carcinoma
- Trial name
- NCT02475213
- Testing
- Enoblituzumab Schedule 1, Pembrolizumab, Enoblituzumab Schedule 2
- Where
- 20 sites in United States
- Volunteers
- 146 people
- Sponsor
- MacroGenics
Glioblastoma (GBM)
A Phase 1/2 Study of the Safety and Tolerability of MT-125 in GBM Patients
The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with…
- Trial name
- STAR-GBM (NCT07185880)
- Testing
- MT-125
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Myosin Therapeutics Inc.
Healthy
Tolerability and Safety of BDB-001 Injection in Healthy Subjects
A clinical study to evaluate the tolerability, PK and PD characteristics of BDB-001 Injection in healthy subjects.
- Trial name
- NCT05361005
- Testing
- BDB-001 injection
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Advanced Solid Tumors
First in Human Study of YB1-X7 Injection
This clinical trial is an open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic, and preliminary efficacy of YB1-X7 injection in subjects with advanced solid tumors.
- Trial name
- NCT06889675
- Testing
- YB1-X7 Injection (IT), YB1-X7 Injection (IV), PD-1 inhibitor
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Shaoxing Salvectors Biotechnology LTD.
Solid Tumors
Safety Study of MG1102 in Patients With Solid Tumors
To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in patients with solid tumors for which no standard therapy is available.
- Trial name
- NCT01809912
- Testing
- Recombinant human apolipoprotein(a) Kringle V
- Where
- South Korea
- Volunteers
- 16 people
- Sponsor
- Green Cross Corporation
Healthy
Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1)
This is a Phase I, open label, dose escalation study designed to evaluate the pharmacokinetics, safety, and tolerability of single intramuscular injections of Letrozole ISM® at different strengths in voluntary healthy post…
- Trial name
- NCT03401320
- Testing
- Letrozole ISM
- Where
- Czechia
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Rovi Pharmaceuticals Laboratories
Advanced Breast Cancer
Treating Nectin-4-positive Advanced Breast Cancer with XKDCT293 (Nectin-4-CAR-T)
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT 293 (Nectin-4-CAR-T) in Nectin-4-positive advanced breast cancer
- Trial name
- NCT06724835
- Testing
- XKDCT293, CAR-T cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shenzhen Celconta Life Science Co., Ltd.
Advanced Solid Tumors Cancer
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced…
- Trial name
- NCT02099058
- Testing
- Osimertinib, Nivolumab, Telisotuzumab vedotin
- Where
- 36 sites in United States, Belgium and 7 more
- Volunteers
- 237 people
- Sponsor
- AbbVie
Polymyositis, Dermatomyositis
Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis
To determine the maximum tolerated dose (MTD) based on the safety and tolerability after single-dose administration of PN-101 in patients with refractory polymyositis or dermatomyositis.
- Trial name
- NCT04976140
- Testing
- PN-101
- Where
- 3 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Paean Biotechnology Inc.
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