Clinical Trials / Browse by Phase / Phase 1 / Phase 2
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Phase 1 / Phase 2 Clinical Trials

Phase 1/2 combined trials evaluate both safety (Phase 1) and preliminary efficacy (Phase 2) in a single study protocol, often used to accelerate early development.

Total Trials
393
Recruiting Now
393
Top Conditions in Phase 1 / Phase 2
Advanced Solid Tumor (16) Advanced Solid Tumors (13) Solid Tumor, Adult (8) Ovarian Cancer (8) Solid Tumor (7) Colorectal Cancer (6) Prostate Cancer (6) Acute Myeloid Leukemia (5) Triple Negative Breast Cancer (5) Endometrial Cancer (5)

Frequently Asked Questions — Phase 1 / Phase 2 Trials

What are combined Phase 1/2 clinical trials?
Phase 1/2 trials are adaptive designs that evaluate both safety (Phase 1 objectives) and preliminary efficacy (Phase 2 objectives) within a single trial protocol. They are commonly used in oncology and rare disease research to accelerate development timelines. Dose escalation occurs in the Phase 1 portion, followed by expansion cohorts at the selected dose in the Phase 2 portion.
Why do sponsors combine Phase 1 and Phase 2?
Combining phases reduces development time and cost, particularly for conditions with high unmet need. For rare diseases or cancer indications, finding sufficient eligible patients can be challenging—a combined design uses the same patient pool more efficiently. Regulatory agencies including the FDA encourage adaptive designs to accelerate evidence generation for serious conditions.
How do I find Phase 1/2 trials I can join?
Phase 1/2 trials listed on ClinicalMetric are sourced from ClinicalTrials.gov and filtered by recruitment status. Each listing shows enrollment status, conditions studied, sponsor, participating sites, and estimated enrollment. Because Phase 1/2 trials often have narrow eligibility criteria, carefully review the protocol and discuss potential participation with your treating physician.

Active Phase 1 / Phase 2 Studies

NCT07545265 Phase 1, Phase 2
Recruiting
SKB565 for Injection in Advanced Solid Tumors
Condition
Advanced Solid Tumors
Enrollment
180 pts
Location
China
Sponsor
Sichuan Kelun-Biotech Biopharm
View Trial →
NCT07136428 Phase 1, Phase 2
Recruiting
Asciminib in HER2+ Breast Cancer Brain Metastases
Condition
HER2+ Metastatic Breast Cancer
Enrollment
42 pts
Location
United States
Sponsor
Duke University
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NCT06427941 Phase 1, Phase 2
Recruiting
A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With o...
Condition
Metastatic Hepatocellular Carcinoma
Enrollment
630 pts
Location
United States, Brazil, China
Sponsor
BeOne Medicines
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NCT07811037 Phase 1, Phase 2
Recruiting
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinet...
Condition
Advanced Solid Tumor
Enrollment
332 pts
Location
China
Sponsor
Beijing Sungen Biomedical Tech
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NCT06940739 Phase 1, Phase 2
Recruiting
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanc...
Condition
Unresectable Melanoma
Enrollment
42 pts
Location
United States, Australia
Sponsor
Iovance Biotherapeutics, Inc.
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NCT05739981 Phase 1, Phase 2
Recruiting
Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnose...
Condition
Ovarian Cancer
Enrollment
30 pts
Location
United States
Sponsor
Imunon
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NCT05858983 Phase 1, Phase 2
Recruiting
Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystro...
Condition
Biallelic RPE65 Mutation-associated Retinal Dystrophy
Enrollment
9 pts
Location
China
Sponsor
Frontera Therapeutics
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NCT03255408 Phase 1, Phase 2
Recruiting
Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Inter...
Condition
Obstructive Sleep Apnea of Adult
Enrollment
12 pts
Location
Canada
Sponsor
University of Calgary
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NCT07398508 Phase 1, Phase 2
Recruiting
NORTHERA (DROXIDOPA) for Dysautonomia in Pediatric Survivors of Menkes Disease
Condition
Menkes Disease
Enrollment
6 pts
Location
United States
Sponsor
Stephen G. Kaler
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NCT04008368 Phase 1, Phase 2
Recruiting
Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell ...
Condition
Myeloid Chimerism
Enrollment
32 pts
Location
United States
Sponsor
National Heart, Lung, and Bloo
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NCT05675813 Phase 1, Phase 2
Recruiting
Genotype-guided Treatment in Newly Diagnosed PTCL
Condition
Peripheral T Cell Lymphoma
Enrollment
264 pts
Location
China
Sponsor
Ruijin Hospital
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NCT07153068 Phase 1, Phase 2
Recruiting
SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Condition
T Lymphoblastic Leukemia/Lymphoma
Enrollment
12 pts
Location
China
Sponsor
Institute of Hematology & Bloo
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NCT07304440 Phase 1, Phase 2
Recruiting
Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study
Condition
Autism Spectrum Disorder
Enrollment
100 pts
Location
United States
Sponsor
Adia Med of Winter Park LLC
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NCT07529717 Phase 1, Phase 2
Recruiting
First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostat...
Condition
Metastatic Prostate Cancer
Enrollment
42 pts
Location
United States, Australia, South Korea
Sponsor
AstraZeneca
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NCT05142423 Phase 1, Phase 2
Recruiting
A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors
Condition
Advanced Solid Tumor
Enrollment
198 pts
Location
China
Sponsor
Akeso
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NCT06474468 Phase 1, Phase 2
Recruiting
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in...
Condition
Advanced or Metastatic Esophageal Cancer
Enrollment
148 pts
Location
China
Sponsor
Shanghai Hengrui Pharmaceutica
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NCT07502768 Phase 1, Phase 2
Recruiting
Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
Condition
Extranodal NK/T-cell Lymphoma
Enrollment
107 pts
Location
China
Sponsor
Rong Tao
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NCT06596018 Phase 1, Phase 2
Recruiting
Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemother...
Condition
Breast Adenocarcinoma
Enrollment
96 pts
Location
China
Sponsor
Second Affiliated Hospital, Zh
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NCT04106115 Phase 1, Phase 2
Recruiting
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive ...
Condition
Bladder Cancer
Enrollment
52 pts
Location
United Kingdom
Sponsor
University College, London
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NCT06536049 Phase 1, Phase 2
Recruiting
Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressiv...
Condition
Recurrent Diffuse Large B-Cell Lymphoma
Enrollment
38 pts
Location
United States
Sponsor
Yazeed Sawalha
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NCT05958121 Phase 1, Phase 2
Recruiting
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory ...
Condition
Refractory Cancer
Enrollment
400 pts
Location
Germany, Netherlands
Sponsor
Immatics Biotechnologies GmbH
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NCT07368608 Phase 1, Phase 2
Recruiting
A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated ...
Condition
Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol
Enrollment
340 pts
Location
China
Sponsor
BeBetter Med Inc
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NCT06501625 Phase 1, Phase 2
Recruiting
Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Pa...
Condition
Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Enrollment
52 pts
Location
United States, Australia, Brazil
Sponsor
Institut de Recherches Interna
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NCT05379985 Phase 1, Phase 2
Recruiting
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Muta...
Condition
Non-small Cell Lung Cancer (NSCLC)
Enrollment
754 pts
Location
United States
Sponsor
Revolution Medicines, Inc.
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NCT07348055 Phase 1, Phase 2
Recruiting
A Study of GR1803 in Systemic Lupus Erythematosus
Condition
Systemic Lupus Erthematosus
Enrollment
44 pts
Location
China
Sponsor
Genrix (Shanghai) Biopharmaceu
View Trial →
Page 4 of 16 — 393 trials total
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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology