🇺🇸 FDA

Intelligence · Clinical Pipeline

Phase I Pipeline Programs

First-in-human and early clinical safety studies in Phase I.

Programs
4,713

Quick answer

NovaPharmaNews tracks 4,713 phase i pharmaceutical pipeline programs from ClinicalTrials.gov. First-in-human and early clinical safety studies in Phase I.

Top sponsors

Page 4 of 99

  1. A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors (ARC-20)

    Arcus Biosciences

    Solid Tumors, Clear Cell Renal Cell Carcinoma

    phase 1 other active

    1 trial

  2. A Phase 1 Study of BGB-B3227 Alone and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors

    BEONE MEDICINES AUS PTY LTD

    Solid tumors

    phase 1 other active

    1 trial

  3. A Phase 1 Study of BMS-986406 as Monotherapy and in Combination in Advanced Tumors

    Bristol-Myers Squibb Australia Pty Ltd

    Advanced Malignant Tumors

    phase 1 other active

    1 trial

  4. A Phase 1 Study of BMS-986453 in Participants with Relapsed and/or Refractory Multiple Myeloma

    Celgene Europe Limited

    Relapsed and/or Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  5. A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

    Bristol-Myers Squibb Australia Pty Ltd

    Advanced or metastatic solid tumors, Gastroesophageal cancer (GEC), High grade serous ovarian cancer (HGSOC), Endometrial cancer (EC), Advanced or metastatic breast cancer, Platinum-resistant ovarian cancer (PROC)

    phase 1 other active

    1 trial

  6. A Phase 1 Study of CD19-targeted NEX-T CAR T Cells in Participants with RMS, PMS, or MG(Breakfree-2)

    Celgene Europe Limited

    Myasthenia gravis (MG), Progressive Multiple Sclerosis (PMS), Relapsing Multiple Sclerosis (RMS)

    phase 1 other active

    1 trial

  7. A Phase 1 Study of CD19-targeted NEX-T CAR T Cells in Participants with Severe, Refractory Autoimmune Diseases (Breakfree-1)

    Celgene Europe Limited

    Systemic Sclerosis, Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathy, Systemic Lupus Erythematosus (SLE)

    phase 1 other active

    1 trial

  8. A Phase 1 Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations

    Hutchmed Europe B.V.

    - Acute myeloid leukemia - Myelodysplastic syndrome/ Myeloproliferative neoplasm - Angio-immunoblastic T-cell lymphoma - Other mIDH-positive hematological malignancies (other than tumor types mentioned above)

    phase 1 other active

    1 trial

  9. A Phase 1 Study of HMPL-306 in Locally Advanced Solid Tumors with IDH mutations

    Hutchmed Europe B.V.

    - Locally advanced or metastatic solid tumors - Cholangiocarcinoma - Skeletal chondrosarcoma - Low-grade glioma - Any other solid tumor harboring an IDH mutation

    phase 1 other active

    1 trial

  10. A Phase 1 Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants with Severe, Refractory Autoimmune Diseases

    Bristol-Myers Squibb Australia Pty Ltd

    Systemic Sclerosis, Idiopathic Inflammatory Myopathy, Rheumatoid Arthritis, Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  11. A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

    Janssen-Cilag International N.V.

    Metastatic Castration-Resistant Prostate Cancer

    phase 1 other active

    1 trial

  12. A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

    Janssen-Cilag International N.V.

    Metastatic castration-resistant prostate cancer

    phase 1 other active

    1 trial

  13. A Phase 1 Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors

    Janssen-Cilag International N.V.

    Advanced Stage Solid Tumors

    phase 1 other active

    1 trial

  14. A Phase 1 Study of JNJ-87189401 Combined with JNJ-78278343 for Advanced Prostate Cancer

    Janssen-Cilag International N.V.

    Advanced Prostate Cancer

    phase 1 other active

    1 trial

  15. A Phase 1 Study of JNJ-87562761 in Relapsed/Refractory Multiple Myeloma

    Janssen-Cilag International N.V.

    Relapsed/Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  16. A Phase 1 Study of JNJ-87801493 in Combination with CD3 T-Cell Engagers

    Janssen-Cilag International N.V.

    Non-Hodgkin Lymphoid Malignancies

    phase 1 other active

    1 trial

  17. A Phase 1 Study of JNJ-87890387 for Advanced Solid Tumors

    Janssen-Cilag International N.V.

    Advanced Solid Tumors

    phase 1 other active

    1 trial

  18. A Phase 1 Study of JNJ-88549968, a T-cell Redirecting Antibody, for CALR-mutated Myeloproliferative Neoplasms

    Janssen-Cilag International N.V.

    CALR-mutated Myeloproliferative Neoplasms

    phase 1 other active

    1 trial

  19. A Phase 1 Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

    Janssen-Cilag International N.V.

    Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Types of Myelodysplastic Neoplasms

    phase 1 other active

    1 trial

  20. A Phase 1 Study of JNJ-89862175, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 Antibody Drug Conjugate, for Advanced Solid Tumors.

    Janssen-Cilag International N.V.

    Advanced Solid Tumors

    phase 1 other active

    1 trial

  21. A Phase 1 Study of PRT7732, an Oral SMARCA2 Degrader, in Patients with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

    Prelude Therapeutics Inc

    esophageal, gastric, or gastroesophageal junction adenocarcinoma, esophageal, gastric, or gastroesophageal junction squamous cell carcinoma, Non-small cell lung cancer (NSCLC), Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

    phase 1 other active

    1 trial

  22. A Phase 1 Study of TAS0612 in Patients with Locally Advanced or Metastatic Solid Tumors

    Taiho Pharma Netherlands B.V.

    Locally Advanced or Metastatic Solid Tumors

    phase 1 other active

    1 trial

  23. A Phase 1 Study of WVE-007 in Adults Living with Overweight or Obesity

    Elan Pharma International

    Adults Living with Overweight and Obesity

    phase 1 other active

    1 trial

  24. A Phase 1 Study on the effects of LY3410738 (study drug) administered to Patients with Advanced Solid Tumors with IDH1 or IDH2 Mutations

    Eli Lilly Co.

    Patients with IDH1 R132, IDH2 R140 or IDH2 R172-mutant advanced solid tumor types, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma.

    phase 1 other active

    1 trial

  25. A Phase 1 Study to Investigate the Safety and Tolerability of the Study Drug GB-0895 in Mild to Moderate Asthma Patients or Single Dose in Chronic Obstructive Pulmonary Disease (COPD)

    Generate Biomedicines

    mild to moderate asthma, Chronic Obstructive Pulmonary Disease (COPD)

    phase 1 other active

    1 trial

  26. A Phase 1 Trial Assessing Pharmacokinetics and Safety of CAM2056 (Semaglutide Subcutaneous Depot)

    Camurus Pty Ltd

    Body weight management

    phase 1 other active

    1 trial

  27. A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants with Recurrent, Advanced or Metastatic Solid Tumors

    Eli Lilly Co.

    Advanced/metastatic solid tumor

    phase 1 other active

    1 trial

  28. A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 as monotherapy and in combination with bevacizumab in adult subjects with advanced solid tumors

    AbbVie Deutschland GmbH & Co. KG

    Advanced solid tumors including (but not limited to), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastric/gastroesophageal junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC)

    phase 1 other active

    1 trial

  29. A Phase 1 first-in-human study evaluating safety, pharmacokinetics and efficacy of ABBV-706 as monotherapy and in combination with budigalimab (ABBV-181), carboplatin, or cisplatin in adult subjects with advanced solid tumors.

    AbbVie Deutschland GmbH & Co. KG

    Advanced solid tumors

    phase 1 other active

    1 trial

  30. A Phase 1 first-in-human study to evaluate SAR447754 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis.

    Sanofi-aventis Healthcare Pty Ltd

    Dermatitis atopic

    phase 1 other active

    1 trial

  31. A Phase 1 open-label positron emission tomography TRIAL to assess changes in liver uptake of [68Ga]Ga-FAPI-46 following oral administration of single doses of AZD2389 to patients with advanced liver fibrosis (PECHORA)

    AstraZeneca AB

    advanced liver fibrosis

    phase 1 other active

    1 trial

  32. A Phase 1 open-label, first-in-human, multi-center, dose escalation and dose expansion study of CLN-619 administered alone or in combination with pembrolizumab in patients with advanced solid tumors.

    Cullinan Therapeutics

    Solid tumors, Non-Small Cell Lung Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, breast cancer, gastrointestinal cancer

    phase 1 other active

    1 trial

  33. A Phase 1 relative bioavailability study in 14 healthy adult participants investigating the Arvisol® tablets to see whether its pharmacokinetic properties are similar to the reference drug which is a marketed oral soliton cannabidiol, named Epidiolex® CBD oral solution.

    Lacuna Pharma Pty Ltd

    Healthy volunteers

    phase 1 other active

    1 trial

  34. A Phase 1 study of GSK5764227 in participants with advanced solid tumors

    GlaxoSmithKline

    Neoplasms

    phase 1 other active

    1 trial

  35. A Phase 1 study of JNJ-95437446 in participants with advanced-stage solid tumors

    Janssen-Cilag International N.V.

    Locally advanced, metastatic NSCLC, CRC, or HNSCC that has recurred or progressed after prior stand of care therapy

    phase 1 other active

    1 trial

  36. A Phase 1 study to evaluate IK-930 in subjects with advanced solid tumors

    Wuhan Createrna Science and Technology Co., Ltd

    Advanced Solid Tumors

    phase 1 other active

    1 trial

  37. A Phase 1 study to evaluate the metabolism of [14C]PF-07104091 in healthy adult male participants

    Pfizer Australia Pty Ltd

    (HR) -positive human epidermal growth factor receptor 2 (HER2) -negative breast cancer (BC), non-small cell lung cancer (NSCLC), ovarian cancer, and triple negative breast cancer (TNBC)

    phase 1 other active

    1 trial

  38. A Phase 1 study to test for safety and activity of an oral investigational drug, in patients with AML or other blood or bone marrow malignacies with an IDH1 mutation.

    The George Institute

    AG-120 is being investigated for the treatment of patients with advanced hematologic malignancies that are IDH1 mutation.

    phase 1 other active

    1 trial

  39. A Phase 1 study to test the safety of an oral investigational drug (either AG-120 or AG-221) in combination with standard chemotherapeutic treatment for patients newly diagnosed with a blood malignancy (AML) with an IDH1 mutation and/or IDH2 mutation

    The George Institute

    Newly Diagnosed Acute Myeloid Leukemia with an IDH1 and/or IDH2 Mutation

    phase 1 other active

    1 trial

  40. A Phase 1, Dose-Escalating, Randomized, Placebo-Controlled, 4-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of COR-1167 in Healthy Subjects and Subjects with Chronic Heart Failure (CHF)

    Lacuna Pharma Pty Ltd

    Chronic heart failure

    phase 1 other active

    1 trial

  41. A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After a Single Dose and Multiple Doses of Orally Administered DF-006 in Healthy Subjects (Part 1 and Part 2) and in Chronic Hepatitis B Patients (Part 3). Protocol Number Df-006-1001

    Wuhan Createrna Science and Technology Co., Ltd

    Chronic Hepatitis B

    phase 1 other active

    1 trial

  42. A Phase 1, Double-blind, Randomized, Three-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of a Single Subcutaneous Dose of PBP1502, EU-Humira®, and US-Humira® in Healthy Male and Female Subjects

    Lacuna Pharma Pty Ltd

    Healthy volunteers

    phase 1 other active

    1 trial

  43. A Phase 1, First-in-Human Study of MEN2312, a KAT6 inhibitor, as Monotherapy and in Combination in Participants with Advanced Breast Cancer

    Stemline Therapeutics B.V.

    Advanced ER+/HER2- Breast Cancer

    phase 1 other active

    1 trial

  44. A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants with Relapsed/Refractory B-cell NHL

    Janssen-Cilag International N.V.

    relapsed or refractory B‑cell non-Hodgkin lymphomas

    phase 1 other active

    1 trial

  45. A Phase 1, First-in-Human, Dose Escalation Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms

    Janssen-Cilag International N.V.

    Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Types of Myelodysplastic Neoplasms

    phase 1 other active

    1 trial

  46. A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants with NHL and CLL

    Janssen-Cilag International N.V.

    Relapsed/refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

    phase 1 other active

    1 trial

  47. A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL

    Janssen-Cilag International N.V.

    Non-Hodgkin lymphoma and chronic lymphocytic leukemia

    phase 1 other active

    1 trial

  48. A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Amivantamab (JNJ61186372), a Human Bispecific EGFR and cMet Antibody, in Participants with Advanced Non-Small Cell Lung Cancer

    Janssen-Cilag International N.V.

    Advanced Non-Small Cell Lung Cancer

    phase 1 other active

    1 trial

Frequently asked questions

How many Phase I pipeline programs are in the directory?

4,713 published programs match this development stage in our ClinicalTrials.gov index.

What defines this pipeline stage?

Phase and status reflect ClinicalTrials.gov registry fields at last sync. See our clinical trial phases reference for methodology.

Data attribution: Data sources · All pipeline programs

Drug approvals, clinical trials, M&A, event intelligence, and company updates — weekly.

Customize topics & region
Topics
Region

No spam. Unsubscribe anytime. See our privacy policy.