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Phase 1 Clinical Trials

Phase 1 trials test a new drug or treatment in a small group (20–80 people) for the first time. The primary goal is to evaluate safety, determine a safe dosage range, and identify side effects.

Total Trials
584
Recruiting Now
584
Top Conditions in Phase 1
Solid Tumor (25) Advanced Solid Tumor (25) Ovarian Cancer (14) Acute Myeloid Leukemia (14) Advanced Solid Tumors (12) Breast Cancer (10) Cervical Cancer (10) Hepatocellular Carcinoma (9) Endometrial Cancer (9) Colorectal Cancer (9)

Frequently Asked Questions — Phase 1 Trials

What is tested in a Phase 1 clinical trial?
Phase 1 trials test a new drug or treatment in a small group of 20–80 people for the first time. The primary goals are to evaluate safety, determine a safe dosage range, identify side effects, and study how the drug is metabolized and excreted. Phase 1 trials typically enroll patients with the target condition who have exhausted standard treatment options, or healthy volunteers in some cases.
How long do Phase 1 clinical trials last?
Phase 1 trials typically last several months to one year depending on the drug, dose-escalation protocol, and follow-up period. The relatively small patient cohort and focused safety objectives make Phase 1 the shortest stage in clinical development. Some are extended into Phase 1/2 combined designs to simultaneously gather early efficacy signals.
Are Phase 1 clinical trials safe to join?
Phase 1 trials are the first human tests of a new intervention and carry the most uncertainty about safety. All Phase 1 studies must be approved by an Institutional Review Board (IRB) and operate under strict FDA oversight. Participants receive intensive monitoring throughout the study. While risks exist, Phase 1 protocols use conservative dosing and frequent safety assessments to protect participants.

Active Phase 1 Studies

NCT06326502 Phase 1
Recruiting
A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) ...
Condition
Hepatocellular Carcinoma
Enrollment
50 pts
Location
South Korea
Sponsor
Etnova Therapeutics Corp.
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NCT06541639 Phase 1
Recruiting
EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
Condition
Advanced or Recurrent Solid Tumors
Enrollment
78 pts
Location
China
Sponsor
Peking University
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NCT07334119 Phase 1
Recruiting
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in...
Condition
HER2-Expressing Solid Tumors
Enrollment
60 pts
Location
Australia
Sponsor
Myeloid Therapeutics
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NCT07377565 Phase 1
Recruiting
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a...
Condition
Celiac Disease
Enrollment
20 pts
Location
United States
Sponsor
Nielsen Fernandez-Becker
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NCT06980428 Phase 1
Recruiting
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynam...
Condition
Healthy Participants
Enrollment
171 pts
Location
United States
Sponsor
AstraZeneca
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NCT05010772 Phase 1
Recruiting
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or...
Condition
Acute Myeloid Leukemia
Enrollment
125 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT06793956 Phase 1
Recruiting
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extra...
Condition
Extranodal Natural Killer/T Cell Lymphoma
Enrollment
12 pts
Location
China
Sponsor
Sun Yat-sen University
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NCT07783477 Phase 1
Recruiting
A Study of Armored CAR T Cells in People With Cancer
Condition
Neuroendocrine Cancer
Enrollment
16 pts
Location
United States
Sponsor
Memorial Sloan Kettering Cance
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NCT04375631 Phase 1
Recruiting
CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Ce...
Condition
Recurrent Acute Myeloid Leukemia
Enrollment
120 pts
Location
United States
Sponsor
Fred Hutchinson Cancer Center
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NCT04510051 Phase 1
Recruiting
CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurren...
Condition
Malignant Brain Neoplasm
Enrollment
18 pts
Location
United States
Sponsor
City of Hope Medical Center
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NCT07467629 Phase 1
Recruiting
QLS5212 for Participants With Advanced Solid Tumors
Condition
Solid Tumor Cancer
Enrollment
100 pts
Location
China
Sponsor
Qilu Pharmaceutical Co., Ltd.
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NCT04104412 Phase 1
Recruiting
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy...
Condition
Lumbar Discogenic Pain
Enrollment
242 pts
Location
China
Sponsor
Sclnow Biotechnology Co., Ltd.
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NCT05954312 Phase 1
Recruiting
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-1300...
Condition
Advanced Solid Tumors
Enrollment
290 pts
Location
United States, South Korea, Spain
Sponsor
Vividion Therapeutics, Inc.
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NCT06773312 Phase 1
Recruiting
BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negativ...
Condition
Advanced or Metastatic Gastric Cancer
Enrollment
80 pts
Location
China
Sponsor
Sichuan Luzhou Buchang Biophar
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NCT06809712 Phase 1
Recruiting
Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem...
Condition
Hematologic Disease
Enrollment
29 pts
Location
China
Sponsor
He Huang
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NCT07513129 Phase 1
Recruiting
Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adol...
Condition
T-cell Acute Lymphoblastic Leukemia
Enrollment
18 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT02646475 Phase 1
Recruiting
Metabolic Effects of Angiotensin-(1-7)
Condition
Obesity
Enrollment
26 pts
Location
United States
Sponsor
Vanderbilt University
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NCT07474545 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 I...
Condition
Healthy Volunteers
Enrollment
76 pts
Location
China
Sponsor
Hunan Kelun Pharmaceutical Co.
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NCT07535112 Phase 1
Recruiting
A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in Peo...
Condition
Advanced/Metastatic Colorectal Adenocarcinoma
Enrollment
130 pts
Location
United States, Australia, Belgium
Sponsor
Bayer
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NCT05952947 Phase 1
Recruiting
HRYZ-T101 Injection for HPV18 Positive Solid Tumor
Condition
Cervical Cancer
Enrollment
32 pts
Location
China
Sponsor
HRYZ Biotech Co.
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NCT06070649 Phase 1
Recruiting
The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT),...
Condition
Alcohol Use Disorder (AUD)
Enrollment
63 pts
Location
United States
Sponsor
Yale University
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NCT05832515 Phase 1
Recruiting
AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patien...
Condition
Multiple Sclerosis
Enrollment
200 pts
Location
Russia
Sponsor
St. Petersburg State Pavlov Me
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NCT05868174 Phase 1
Recruiting
Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase I...
Condition
Solid Tumor, Adult
Enrollment
36 pts
Location
Australia
Sponsor
Telix Pharmaceuticals (Innovat
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NCT07876076 Phase 1
Recruiting
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in H...
Condition
Healthy
Enrollment
88 pts
Location
Australia
Sponsor
Adaxion Therapeutics
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NCT06710158 Phase 1
Recruiting
Study of SC-102 in Patients With Advanced Solid Tumors
Condition
Advanced Solid Cancers
Enrollment
120 pts
Location
China
Sponsor
Tianjin ConjuStar Biologics Co
View Trial →
Page 12 of 24 — 584 trials total
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