Clinical trials: Phase 1b
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.
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
Solid Neoplasms
A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor
The primary purpose of the study is to evaluate safety and tolerability of E7389 liposomal formulation (E7389-LF) in combination with nivolumab and to determine the recommended Phase 2 dose (RP2D) in Phase 1b part and to evaluate…
- Trial name
- NCT04078295
- Testing
- E7389-LF, Nivolumab
- Where
- 19 sites in Japan
- Volunteers
- 125 people
- Sponsor
- Eisai Co., Ltd.
Breast Neoplasm
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Participants With Metastatic Triple-Negative Breast Cancer (mTNBC)
This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in combination with pembrolizumab in participants with mTNBC previously treated with 0 (stratum 1) or 1 to 2 (stratum 2) lines of systemic…
- Trial name
- ENHANCE-1 (NCT02513472)
- Testing
- Eribulin Mesylate, Pembrolizumab
- Where
- 22 sites in United States
- Volunteers
- 258 people
- Sponsor
- Eisai Inc.
Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma
A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies
Protocol YY-20394-007 is a phase1 open-label, single-arm, multi-centre study to assess the safety and efficacy of YY-20394 in participants with relapse and/or refractory B cell malignant hematological tumor.
- Conditions
- Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma
- Trial name
- NCT04279405
- Testing
- YY-20394
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
Tumors
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced…
- Trial name
- NCT00298675
- Testing
- BSI-201 (iniparib), irinotecan
- Where
- 3 sites in United States
- Volunteers
- 59 people
- Sponsor
- Sanofi
Acne
Absorption and Systematic Pharmacokinetics of IDP-121 Lotion in Subjects With Acne Vulgaris
Open-Label study designed to assess the safety and plasma PK of tretinoin and relevant metabolites after topical dermal application of IDP-121 lotion.
- Trial name
- NCT02849860
- Testing
- IDP-121 Lotion
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Bausch Health Americas, Inc.
Leukemia, Leukemia, Myeloid
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia
- Trial name
- NCT06501196
- Testing
- BH-30236, Venetoclax
- Where
- 13 sites in United States
- Volunteers
- 170 people
- Sponsor
- BlossomHill Therapeutics
Glioblastoma, Malignant Glioma
Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer
This study is for newly diagnosed WHO Grade IV malignant glioma patients to determine whether an investigational drug known as marizomib (MRZ) will improve the treatment of newly diagnosed glioblastoma patients by delaying the…
- Trial name
- NCT02903069
- Testing
- MRZ, TMZ, RT
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 66 people
- Sponsor
- Celgene
Cystic Fibrosis
Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
This is a phase 1b multiple ascending dose escalation study to evaluate the safety and tolerability of arginase inhibitor CB-280 in subjects with cystic fibrosis.
- Trial name
- NCT04279769
- Testing
- CB-280
- Where
- 20 sites in United States, Canada
- Volunteers
- 32 people
- Sponsor
- Calithera Biosciences, Inc
Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Colorectal Cancer, Squamous Cell Carcinoma of the Lung
- Trial name
- NCT04429542
- Testing
- BCA101, Pembrolizumab
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 473 people
- Sponsor
- Bicara Therapeutics
Schizophrenia
A Multiple Ascending Dose Trial of CVL-231 in Subjects With Schizophrenia
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-231 following multiple-dose oral administration in subjects with schizophrenia.
- Trial name
- NCT04136873
- Testing
- CVL-231
- Where
- 5 sites in United States
- Volunteers
- 130 people
- Sponsor
- Cerevel Therapeutics, LLC