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 Ansvarig forskn.sköt

Plan.
antal

Akt.
inkl.

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

Rickard Svärd / Mette Wallin

20

39

16/27

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

1

2017-01-20

Jeffrey Yachnin

Mette Wallin / Rickard Svärd

20

38

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

Mette Wallin / Rickard Svärd

10

4

18/030

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

Ej tillä

2019-06-12

Jeffrey Yachnin

Karl-Johan Ekdahl

70

203

18/044

CANFOUR. An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors.

1-2

2019-05-20

Jeffrey Yachnin

Anna Kullenberg/ Mette Wallin

8

4

19/061

ATOR-1017. A first-in-human, multicenter, open-label, phase 1 study in patients with advanced solid malignancies to evaluate the safety of intravenously administered ATOR-1017

1

2019-11-04

Jeffrey Yachnin

Mette Wallin / Rickard Svärd

10

6

19/062

BI-1206 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

Therese Svedin/Jenny Pollack

16

5

19/066

Agent-007-studien. A Phase 2 Study of Olaparib in Combination with Pembrolizumab in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer

2

2020-03-11

Jeffrey Yachnin

Jenny Pollack / Rickard Svärd

3

1

19/095

Spencer-study. A phaSe 1/2 trial of EO2401, a novel microbial-derived Peptide therapeutic vaccine, in combination with PD-1 check point blockadE, for treatment of patients with locally advaNced or metastatic adrenocortical Carcinoma, or malignant phEochromocytoma/paRaganglioma

1-2

2021-05-20

Dan Granberg

Rickard Svärd / Jenny Pollack

1

1

20/004

Navigate. A Phase II Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects with NTRKFusion-Positive Tumours

2

2020-12-01

Jeffrey Yachnin

Rickard Svärd / Mette Wallin

2

1

20/023

TAS-120-202 (SOFFA). Phase II Study of Futibatinib in Patients with Specific FGFR Aberations

2

2020-11-06

Jeffrey Yachnin

Jenny Pollack / Therese Svedin / Mette Wallin

4

2

20/031

BiTE-U (AMG160_20190505). A Master Protocol Evaluating the Safety and Efficacy of AMG 160 in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)

1

2021-09-10

Jeffrey Yachnin

Johanna Uggla / Mette Wallin

5

1

20/033

ZENYTH-ESO (GSK 209012). Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered Tcells, alone or in combination with other agents, in Participants with Advanced Tumors

1

2021-03-04

Jeffrey Yachnin

Mette Wallin / Therese Svedin

2

2

20/086

TIMEPOINT. AN OPEN LABEL PHASE 1A/B STUDY OF MTL-CEBPA IN COMBINATION WITH A PD-1 INHIBITOR (PEMBROLIZUMAB) IN ADULT PATIENTS WITH ADVANCED SOLID TUMOURS

1

2021-12-01

Jeffrey Yachnin

Jenny Pollack/Rickard Svärd

6

0

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

Mette Wallin

10

0

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

Therese Svedin/ Mette Wallin

2

0

21/015

OPUS INCB 99318-122. A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors

1

2021-11-03

Jeffrey Yachnin

Anna Kullenberg/Mette Wallin

5

1

21/043

CCS1477-02. An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy in patients with hematological malignancies

1-2

2022-02-07

Maria Creignou

Johanna Uggla / Anna Kullenberg

4

0

21/044

CCS1477-01. An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination in patients with advanced solid/metastatic tumours

1-2

2022-02-10

Jeffrey Yachnin

Johanna Uggla / Anna Kullenberg

0

0

21/050

FIRST (RLY-4008-101). A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

1

2021-09-23

Jeffrey Yachnin

Jenny Pollack / Mette Wallin

2

4

21/051

iPCM. iPCM - implementation of Personalised Cancer Medicine

Ej tillä

2021-09-24

Jeffrey Yachnin

Karl-Johan Ekdahl

700

15

Nr: Forskningsrådets nummer.
Namn: Studiens kortnamn följt av protokollets hela titel.
Fas: Kan vara fas 1, 2, 3 eller pilot eller kombinationer av dessa.
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 28.05.2022