Clinical trials: Phase 1b
Oesophageal Cancer
A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced, inoperable oesophageal cancer progressing…
- Trial name
- NCT02489201
- Testing
- donafenib tosilate tablets
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Chronic Hepatitis B
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral…
- Trial name
- NCT03109730
- Testing
- ABI-H0731, Entecavir, Tenofovir Disoproxil Fumarate
- Where
- 14 sites in Australia, Hong Kong and 3 more
- Volunteers
- 38 people
- Sponsor
- Assembly Biosciences
Hearing Loss, Sensorineural
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss.
- Trial name
- NCT05664100
- Testing
- FX-345
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Frequency Therapeutics
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination…
- Trial name
- NCT02909972
- Testing
- ALRN-6924, ALRN-6924 in combination with cytarabine
- Where
- 6 sites in United States
- Volunteers
- 55 people
- Sponsor
- Aileron Therapeutics, Inc.
Non-Secretory Plasma Cell Myeloma, Plasmacytosis
Panobinostat and Carfilzomib in Treating Participants With Relapsed or Refractory Multiple Myeloma
This phase I/Ib trial studies the side effects and best dose of panobinostat and carfilzomib in treating participants with multiple myeloma that has come back or that isn't responding to treatment.
- Conditions
- Non-Secretory Plasma Cell Myeloma, Plasmacytosis, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Trial name
- NCT01301807
- Testing
- Carfilzomib, Panobinostat
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- M.D. Anderson Cancer Center
Osteogenesis Imperfecta
Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)
SAR439459 is a human anti-Transforming growth factor β (TGFβ) monoclonal antibody. This phase 1 clinical study investigates the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with OI.
- Trial name
- NCT05231668
- Testing
- SAR439459
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 16 people
- Sponsor
- Sanofi
COVID-19
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
- Trial name
- NCT04591717
- Testing
- hAd5-S-Fusion+N-ETSD vaccine
- Where
- 2 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
SLE, SLE (Systemic Lupus)
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06613360
- Testing
- CLN-978
- Where
- 24 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Cullinan Therapeutics Inc.
Cancer, Breast Cancer
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
- Conditions
- Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer
- Trial name
- NCT06533059
- Testing
- ALTA2618
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 110 people
- Sponsor
- Alterome Therapeutics, Inc.
Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors.
- Trial name
- NCT07287917
- Testing
- AMXT 1501 Dicaprate, DFMO, Fulvestrant
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Aminex Therapeutics, Inc.
Advanced Renal Cell Carcinoma, Advanced Melanoma
Sitagliptin With Pembro in RCC and Melanoma
This study is testing whether adding the drug sitagliptin to the standard immunotherapy pembrolizumab is safe and may help people with advanced melanoma or advanced renal cell carcinoma (kidney cancer) whose cancer has stopped…
- Trial name
- NCT07634380
- Testing
- Sitagliptin, Pembrolizumab
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Fernando Maciel Barbosa
Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor…
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer
- Trial name
- MOONRAY-01 (NCT06586515)
- Testing
- LY3962673, Cetuximab, Gemcitabine
- Where
- 52 sites in United States, Canada and 7 more
- Volunteers
- 630 people
- Sponsor
- Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)
The study consisted of a Phase 1 dose escalation/dose de-escalation portion to determine a safe and tolerable combination dose(s) of cabozantinib and erlotinib, and a Phase 2 Simon optimal 2-stage design portion with randomized…
- Trial name
- NCT00596648
- Testing
- XL184, erlotinib
- Where
- 13 sites in United States
- Volunteers
- 92 people
- Sponsor
- Exelixis
Systemic Lupus Erythematosus
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Trial name
- NCT07011043
- Testing
- Budoprutug
- Where
- 18 sites in United States, Bulgaria and 6 more
- Volunteers
- 30 people
- Sponsor
- Climb Bio, Inc.
Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer
Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer
This is a phase 1b study in adult patients diagnosed with resistant or recurrent head and neck squamous cell carcinoma (HNSCC) designed to assess the safety and tolerability of IK-175 in combination with nivolumab.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, Head Cancer, Neck Cancer
- Trial name
- NCT05472506
- Testing
- IK-175 + nivolumab
- Where
- 4 sites in United States
- Sponsor
- Ikena Oncology
Melanoma Metastatic, Melanoma of Skin
Different Doses of BI-1607 in Combination With Pembrolizumab and Ipilimumab, in Participants With Unresectable or Metastatic Melanoma
Why the research is needed: Researchers are looking for a better way to treat melanoma that has spread or cannot be removed surgically.
- Conditions
- Melanoma Metastatic, Melanoma of Skin, Melanoma BRAF V600E/K Mutated, Melanoma Recurrent
- Trial name
- NCT06784648
- Testing
- pembrolizumab (KEYTRUDA®), BI-1607, Ipilimumab (YervoyTM, 50 mg/10 mL solution)
- Where
- 4 sites in Germany, Spain and 1 more
- Volunteers
- 35 people
- Sponsor
- BioInvent International AB
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors
A Phase 1b, open-label, dose escalation study of PRS-343 in combination with atezolizumab in patients with HER2-positive advanced or metastatic solid tumors.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Bladder Cancer, HER2-positive Solid Tumor
- Trial name
- NCT03650348
- Testing
- PRS-343 in Combination with Atezolizumab
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- Pieris Pharmaceuticals, Inc.
Corona Virus Infection
A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19
Primary Objective: To evaluate the effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by C-reactive protein (CRP) levels in adult patients hospitalized with severe coronavirus disease 2019…
- Trial name
- NCT04469621
- Testing
- SAR443122
- Where
- 10 sites in Argentina, Brazil and 3 more
- Volunteers
- 68 people
- Sponsor
- Sanofi
Advanced Solid Tumours
Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours
A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.
- Trial name
- NCT05920408
- Testing
- EXS21546
- Where
- 5 sites in Belgium, France
- Volunteers
- 6 people
- Sponsor
- Exscientia AI Limited
Breast Cancer
The HeartSpare Plus 1B Trial
This study aims to compare the resource impact, acute toxicity and feasibility of different pan-lymph node radiotherapy techniques.
- Trial name
- NCT02771353
- Testing
- WT_vDIBH, VMAT_FB
- Volunteers
- 39 people
- Sponsor
- Royal Marsden NHS Foundation Trust