Clinical trials: Phase I
Chronic Myeloid Leukemia
A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia
This study is constituted of two stage: Treatment-Free Remission 1 (TFR1) stage and Treatment-Free Remission 2 (TFR2) stage. The purpose of the TFR1 stage is to assess the effect of nilotinib reduced to half the standard dose for…
- Trial name
- DANTE (NCT03874858)
- Testing
- Nilotinib, Asciminib
- Where
- 26 sites in Italy
- Volunteers
- 135 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor (Phase 1)
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
This the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) / pharmacodynamic (PD)…
- Trial name
- NCT07163325
- Testing
- EP102
- Where
- 11 sites in Belgium, Czechia and 2 more
- Volunteers
- 48 people
- Sponsor
- Epics Therapeutics
Non Small Cell Lung Cancer, Cervical Cancer
A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4
The main goal of this study is to evaluate how safe and tolerable RNDO-564 is and to identify the best dose of RNDO-564 as a single agent and in combination with pembrolizumab.
- Conditions
- Non Small Cell Lung Cancer, Cervical Cancer, Head and Neck Squamous Cell Cancer, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT07218003
- Testing
- RNDO-564, Pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 149 people
- Sponsor
- Rondo Therapeutics
Advanced Solid Tumor (Phase 1)
An Initial Evaluation of AN8025 in Solid Tumors
The goal of this clinical trial is to determine the appropriate dose of AN8025 for use in the treatment of advanced solid tumors. This study will be conducted in in adults >18 years of age. The main questions to answer: 1.
- Trial name
- NCT07639047
- Testing
- AN8025 is a multifunctional antibody fusion protein
- Where
- Australia
- Volunteers
- 91 people
- Sponsor
- Adlai Nortye Biopharma Co., Ltd.
This is a Phase I Study Conducted in Healthy Volunteers
Single Ascending Dose Study of ATH-097 in Healthy Participants
This is a Phase I, A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ATH-097 in Healthy Participants
- Trial name
- NCT07640269
- Testing
- ATH-097
- Where
- Australia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Atheron Therapeutics, Ltd.
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation
The Drugs Controller General of India (DCGI) has granted approval for Asciminib film-coated 40 mg tablets on 20 Oct 2023 with the condition to perform a Phase IV clinical study in Indian patients with Philadelphia…
- Trial name
- ASC4INDIA (NCT06427811)
- Testing
- Asciminib
- Where
- 10 sites in India
- Volunteers
- 85 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumors (Phase 1), RAS Mutation
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
The goal of this clinical trial is to learn determine if AN9025 is safe and tolerable to treat solid cancer tumors with specific genetic mutations.
- Trial name
- NCT07252479
- Testing
- AN9025 oral capsule
- Where
- 3 sites in United States
- Volunteers
- 118 people
- Sponsor
- Adlai Nortye Biopharma Co., Ltd.
Advanced Solid Tumor (Phase 1), Hodgkin Lymphoma
A Phase I Study of JLM019 Injection
This is a multicenter, single-arm, open-label, dose escalation phase (Part A) and dose expansion (Part B) study to evaluate the safety and tolerability of JLM019 Injection in patients with advanced malignancies.
- Conditions
- Advanced Solid Tumor (Phase 1), Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Trial name
- JLM019 (NCT07623850)
- Testing
- JLM019 Injection
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Jecho Biopharmaceuticals Co., Ltd.
Non Hodgkin Lymphoma, Richter Transformation
Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.
This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing…
- Conditions
- Non Hodgkin Lymphoma, Richter Transformation, Multiple Myeloma, T-cell-prolymphocytic Leukemia
- Trial name
- NCT04771572
- Testing
- LP-118
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Newave Pharmaceutical Inc
Solid Tumors (Phase 1)
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid…
- Trial name
- NCT07561554
- Testing
- HSK42360-Na
- Where
- 2 sites in China
- Volunteers
- 159 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Phase I: Relapsed or Refractory B-cell Malignancies, Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies.
- Conditions
- Phase I: Relapsed or Refractory B-cell Malignancies, Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma, Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia
- Trial name
- NCT03932331
- Testing
- Acalabrutinib
- Where
- 23 sites in China
- Volunteers
- 105 people
- Sponsor
- AstraZeneca
Locally Advanced or Metastatic Solid Tumors for Phase 1, Dose Escalation and Phase 2 Safety Lead-in, HNSCC for Phase 2 Dose Expansion
Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors
This was an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of surzebiclimab (BGB-A425) and/or alcestobart (LBL-007) with tislelizumab.
- Conditions
- Locally Advanced or Metastatic Solid Tumors for Phase 1, Dose Escalation and Phase 2 Safety Lead-in, HNSCC for Phase 2 Dose Expansion, NSCLC for Phase 2 Dose Expansion
- Trial name
- NCT03744468
- Testing
- Surzebiclimab, Tislelizumab, Alcestobart
- Where
- 40 sites in United States, Australia and 4 more
- Volunteers
- 147 people
- Sponsor
- BeiGene
Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in…
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Cml
- Trial name
- CML (NCT05304377)
- Testing
- ELVN-001
- Where
- 45 sites in United States, Australia and 12 more
- Volunteers
- 250 people
- Sponsor
- Enliven Therapeutics
Chronic Myeloid Leukemia in Chronic Phase
Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China
This is a multicenter, non-interventional real-world study designed to assess the efficacy and safety of asciminib in patients with newly diagnosed CML.The study uses a prospective data collection design to gather baseline, pre…
- Trial name
- ASC4CN (NCT07375355)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Phase III
Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection in the Treatment of Moderate-to-Severe Active AS
This is a multicenter, randomized, double-blind, placebo-controlled, and parallel grouping study. Study procedures: The screening period does not exceed 4 weeks, including 16 weeks for initial treatment, 28 weeks for maintenance…
- Trial name
- NCT07498634
- Testing
- XKH004
- Where
- China
- Volunteers
- 323 people
- Sponsor
- Zhejiang Kanova Biopharmaceutical Co., LTD
Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia - Chronic Phase
TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients
A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs
- Trial name
- NCT07489755
- Testing
- TGRX-678, TKI
- Volunteers
- 180 people
- Sponsor
- Shenzhen TargetRx Co., Ltd.
Myeloid Leukemia, Chronic, Chronic Phase
Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses
The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI)…
- Trial name
- OPTIC (NCT02467270)
- Testing
- Ponatinib
- Where
- 86 sites in United States, Argentina and 19 more
- Volunteers
- 283 people
- Sponsor
- Takeda
Phase 1 First-in-human Study Involving Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects
- Trial name
- NCT07473752
- Testing
- TNX-1500, Keyhole Limpet Hemocyanin (KLH)
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Advanced Solid Tumor (Phase 1)
Evaluation of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
This is a first-in-human, non-randomized, open-label, multi-center, phase I study in patients with advanced solid tumor to evaluate the safety and tolerability, PK, immunogenicity, and preliminary anti-tumour activity of T320.
- Trial name
- NCT07434609
- Testing
- T320 for Injection
- Volunteers
- 150 people
- Sponsor
- Nanolattix Biotechnology Co., Ltd.
Psoriasis Vulgaris, Topical Administration
Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III)
The goal of this clinical trial is to learn if a botanical Total Coumarin topical cream (TC Cream) works to treat psoriasis in adults. It will also learn about the safety of the topical TC Cream.
- Conditions
- Psoriasis Vulgaris, Topical Administration, Phase III
- Trial name
- PLANTCOAT-III (NCT07426120)
- Testing
- Total coumarin (TC) cream, Vehicle cream
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Psoriasis Research Institute of Guangzhou