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Algemene medische oncologie

Fase I studies bij diverse tumoren

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Planned

ADCE-D01

A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, PK, and Antitumor activity of ADCE-D01, a Humanized
Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients with Metastatic and/or Unresectable Soft Tissue Sarcoma

BYON 4228.002

Phase 1 / 2: Dose Escalation with monoclonal Antibody in patients with advanced or metastatic solid tumors

  • Principal investigator : Prof. Dr. Oliver Bechter
  • Sponsor : BYONDIS
  • More information : 
  • Indication : Advanced Metastatic Solid Tumors
  • Internal reference number : s70118

DAR-UM-2 - IDE196-002

IDE196 (DAROVASERTIB) IN COMBINATION WITH CRIZOTINIB VERSUS INVESTIGATOR’S CHOICE OF TREATMENT AS FIRST-LINE THERAPY IN HLA-A2 NEGATIVE METASTATIC UVEAL MELANOMA (DAR-UM-2)

  • Principal investigator : Prof. Dr. Paul Clement
  • Sponsor : LKI / IDEAYA Biosciences
  • More information :
  • Indication : HLA-A2 Negative Metastatic Uveal Melanoma
  • Internal reference number : s70071

Ongoing

ADU-1805 - SRP-22C102

An Open-Label, Multicenter, Multi-Arm Phase 1 Study Evaluation the safety and Pharmacokinetics of ADU-1805 in Adults with Advanced Solid Tumors

BAY3375968 - 21820 (Expansion)

First-in-human dose-escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of the anti-CCR8 antibody BAY 3375968 as monotherapy and in combination with pembrolizumab in participants with selected advanced solid tumors

BEAMION BCGC-1  -  BI1479-0012

Beamion BCGC-1: A Phase Ib dose escalation and Phase II dose optimization, randomized, open-label, multicenter trial of oral zongertinib (BI 1810631) in combination with intravenous trastuzumab deruxtecan (T-DXd) or in combination with intravenous trastuzumab emtansine (T-DM1) for treatment of patients with advanced HER2+ metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC)

  • Principal investigator : Prof. Dr. Hans Wildiers
  • Sponsor: Boehringer Ingelheim
  • More information : NCT06324357
  • Indication: HER2+ metastatic + gastric/GEjunction/esophageal
  • Internal reference number : s68772

BP44474

A phase I, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of RO7589831 in participants with advanced solid tumors harboring microsatellite instability (MSI) and/or deficient mismatch repair (DMMR)

BP44956

AN OPEN-LABEL, MULTICENTER, DOSE-ESCALATION, RANDOMIZED, PHASE I STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF RO7567132 AS SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS

DS22243-054

Phase 1, Open-Label, Multicenter, First-In-Human Trial of Ds-2243a in Participants With Advanced Solid Tumors

INCIPIENT

INtra-tumor miCro dosIng in PatIents with advanced malignant mElanoma receiving aNti-PD1 Therapy. A pilot study

  • Principal investigator : Prof. Dr. Oliver Bechter
  • Sponsor : UZ LEUVEN
  • More information : 
  • Indication : Advanced Malignant Melanoma
  • Internal reference number : s68579

MS201460_0001

A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of anti-GD2 Antibody Drug Conjugate M3554 in Participants with Advanced Solid Tumors

StrateGIST-1 - IDRX-42-001

A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

TIG-006 - EOS-448

A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

  • Principal investigator : Prof. Dr. O. Bechter
  • Sponsor : Precision for Medicine
  • More information: NCT05060432
  • Indocation : 
  • Internal reference number : s66042

Closed

BE43244

An Open-Label, Multicenter, Dose-Escalation,  Phase I Study To Evaluate Safety,  Pharmacokinetics, And Preliminary Anti-Tumor  Activity Of RO7444973 In Participants With  Advanced And/Or Metastatic Mage A4-Positive,  Solid Tumors

BI 1403-0001

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 in Patients With Advanced or Metastatic Solid Tumors

BI 1403-0002

A Phase Ia/Ib, Open Label, Dose-escalation Study of the Combination of BI 907828 With BI 754091 (Ezabenlimab) and BI 754111 and the Combination of BI 907828 With BI 754091(Ezabenlimab) Followed by Expansion Cohorts, in Patients With Advanced Solid Tumors

BRIGHTLINE-1 - BI 1403-0008

A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma

1367.1

An open-label, phase Ia/Ib dose finding study with BI 894999 oral administered once a day in patients with advanced solid tumors, with repeated administration in patients with clinical benefit

BOS172738-01

A Phase 1 Study of BOS172738 in Patients With Advanced Solid Tumors With RET Gene Alterations Including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC)

BP41628    

An open label, multicenter, dose escalation and extension, phase Ia/Ib study to evaluate safety, pharmacokinetics, and therapeutic activity of RO7284755, a PD-1 targeted IL-2 variant (IL-2v) immunocytokine, alone or in combination with atezolizumab in participants with advanced and/or metastatic solid tumors

BP41054

An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (Il-2v) Targeting Fibroblast Activation Protein-Α (Fap), In Combination With Pembrolizumab (Anti-Pd-1), In Participants With Previously Untreated Advanced And/Or Metastatic Melanoma 

BP42169

An open-label, multicenter, phase 1 study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7293583, a TYRP1-Targeting CD3 T-Cell Engager, in participants with metastatic melanoma

CNIZ985B12010

A Phase I/Ib Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL-15/sIL-15Rα)) in Combination With Spartalizumab in Patients With Check Point Inhibitor (CPI) Relapsed Advanced Solid Tumors and Lymphoma.

COSMIC-021 XL184-021

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

GCT3009-01

Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts

JAVELIN EMR 100070-001

A phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications

lNCB106385-102

A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

IDH305 CIDH305X210

A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

IVIVC D0816C00024

A Phase 1, Randomised, Open-label, 4-Period Crossover Study to Develop an In Vitro-In Vivo Correlation for Olaparib Tablets in Subjects With Solid Tumor

  • Principal investigator : Dr. K. Punie
  • Sponsor : AstraZeneca
  • More information : NCT03553108
  • Indication : 
  • Internal reference number : s61087

LAG525 CLAG525X2101C

Open label multicenter phase I/II study of the safety and efficacy of LAG525 single-agent and in combination with PDR001 administered to patients with advanced malignancies

MBS8-101

A Phase I Multicentre, Open-label, Dose Escalation Study to Determine the Safety and Preliminary Efficacy of MBS8(1V270) Administered Intravenously to Cancer Patients With Advanced Solid Tumours

NAPOLY CT-CL01

A phase I/II open-label, safety, pharmacokinetic and preliminary efficacy study of Cripec docetaxel in patients with solid tumors

PD1-Fc-OX40L SL01-DEL-101

Phase 1 Dose Escalation and Dose Expansion Study of an Agonist Redirected Checkpoint Fusion Protein, SL-279252 (PD1-Fc-OX40L), in Subjects With Advanced Solid Tumors or Lymphomas

PRAME - IMC-F106C-101

A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

PIVOT-02 NKTR 16-214-02

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

ROLL-OVER CLAG CPDR001X2X01B

An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments

SERVIER 001 CL1-81694-001

Phase I dose-escalation study of S81694 administered intravenously in adult patients with advanced/metastatic solid tumours

SERVIER 003 CL1-81694-003

Phase I/II Trial of S 81694 Administered Intravenously in Combination With Paclitaxel to Evaluate the Safety, Pharmacokinetic and Efficacy in Metastatic Breast Cancer

SYNERGY IJB-SYNERGY-012017

A Phase I/II Study of Paclitaxel Plus Carboplatin and Durvalumab (MEDI4736) With or Without Oleclumab (MEDI9447) for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

TCD14678

A Phase 1/1b First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With REGN2810 in Adult Patients With Advanced Solid Tumors

TED15297

A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

THERADEX GCT1021-01

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (HuMax-Axl-ADC) in patients with solid tumors

WP43295

A Phase IA/B, Open-Label, Multicenter Study Evaluating Safety, Pharmacokinetics, And Preliminary Clinical Activity Of Ro7276389 Alone And In Combination With Cobimetinib In Participants With Braf-V600 Mutation-Positive Advanced Solid Tumor And Participants With Braf-V600 Mutation-Positive Melanoma With Central Nervous System Metastases

  • Principal investigator : Prof. Dr. O. Bechter
  • Sponsor : Roche
  • More information : 
  • Indication : 
  • Internal reference number : s66012
Laatste aanpassing: 9 mei 2025