Kliniska studier vid Tema Cancer

–Studier öppna för inklusion inom Fas 1-enheten–

Nedan listas de studier som är öppna för patientinklusion. Vidare visas ansvarig prövare, forskningssjuksköterska och aktuell inklusion. Listan uppdateras minst en gång i veckan. -Längst ner finns förklaring till de olika kolumnerna.

 Nr Namn

Fas

Startdatum Ansvarig prövare

06/09

SECAR-studien. Part I: A study of MTD of Sodium selenite in patients with advanced carcinoma. A phase I study. Amendment 4: continuous treatment

1

2007-02-01

Mattias Hedman

16/27

MASTIFF. MASTIFF MTH1, A phase I, Study on Tumors Inhibition, First in human, First in class

1

2017-01-20

Jeffrey Yachnin

17/09

BoB. Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumors

2

2019-06-18

Luigi de Petris

18/030

PSFF STUDIE- Blodburna vävnadsprov. Screening-program med blodburna vävnadsprov för patienter med avancerad cancer - PSFF studie

Ej tillämpbar

2019-06-12

Jeffrey Yachnin

18/031

Keynote-587. A multicenter, open label, phase III extension trial to study the long-term safety and efficacy in participants with advanced tumors who are currently on treatment or in follow-up in a pembrolizumab trial.

3

2018-11-20

Jeffrey Yachnin

19/062

BI-1206-03 MonKey. Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD1 or Anti-PDL1 Antibodies

1-2

2020-11-15

Jeffrey Yachnin

20/041

BIKUPAN (19-BI-1808-01). Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Malignancies

1-2

2022-01-27

Jeffrey Yachnin

21/003

ONCORELLA-1 (ONC001-CL-001). A phase I/II, open label, single arm study on safety, tolerability and anti-tumour efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma

1

2022-02-08

Jeffrey Yachnin

21/010

MCLA-128-CL01 eNRGy. A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors

1-2

2021-11-18

Jeffrey Yachnin

21/051

iPCM. iPCM - implementation of Personalised Cancer Medicine

Ej tillämpbar

2021-09-24

Jeffrey Yachnin

21/087

Claudin-6 BNT211-01. Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors

1-2

2023-05-28

Stephan Mielke

22/036

CERTIS1. A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1)

1-2

2023-01-12

Theodoros Foukakis

22/046

NeoGap (NEOGAP-CRC-01). A First-In-Human, Phase I/IIa Trial of the novel T cell Immunotherapy pTTL in Patients with Advanced Colorectal Cancer

1

2023-03-16

Maximilian Kordes

22/063

FORE (F8394-201). A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394, an inhibitor of BRAF class 1 and class 2 alterations, in participants with cancer harboring BRAF alterations

2

2023-06-29

Jeffrey Yachnin

22/067

BIWAC (BI 1403-0001- Brightline). A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 in patients with advanced or metastatic solid tumors

1

2023-03-16

Christina Linder Stragliotto

23/001

Beamion Lung - 1479-0001. An open label, Phase I dose escalation trial, with dose confirmation and expansion, of BI 1810631 as monotherapy in patients with advanced or metastatic solid tumors with HER2 aberrations

1

2023-10-02

Simon Ekman

23/003

BRETON (BGB-16673-101). A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies

1

2023-09-27

Maria Creignou

23/007

OnkoVir (BI 1467-0001). An open-label, Phase I dose escalation and expansion trial to investigate safety and efficacy of BI 1821736 in patients with advanced solid tumors

1

2023-10-18

Maximilian Kordes

23/037

Teneriffa (22 BI-1910-01 TNFR2). Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

1-2

2024-01-26

Jeffrey Yachnin

Nr: Forskningsrådets nummer.
Namn: Studiens kortnamn följt av protokollets hela titel.
Fas: Kan vara Fas 1, 2, 3 eller Pilot, kombinationer av dessa, eller Ej tillämpligt.
Startdatum: Vanligen datum för startmöte eller liknande.
Ansvarig prövare: Den läkare som är ansvarig för studien inom Tema Cancer.
Ansvarig forskn.sköt: Den forskningssjuksköterska som är ansvarig.

CKC, Tema Cancer, Karolinska universitetssjukhuset 24.06.2024