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JOURNAL ONKOLOGIE – STUDIE

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

Rekrutierend

NCT-Nummer:
NCT04262466

Studienbeginn:
Februar 2020

Letztes Update:
02.04.2024

Wirkstoff:
IMC-F106C, IMC-F106C and pembrolizumab, IMC-F106C and chemotherapy, IMC-F106C and monoclonal antibodies and chemotherapy, IMC-F106C and tebentafusp, IMC-F106C and bevacizumab, IMC-F106C and kinase inhibitors

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Immunocore Ltd

Collaborator:
-

Kontakt

Immunocore Medical Information
Kontakt:
Phone: 844-466-8661
E-Mail: medical.information@immunocore.com» Kontaktdaten anzeigen
Immunocore Medical Information EU
Kontakt:
Phone: +00 800-744-51111
E-Mail: medinfo.eu@immunocore.com» Kontaktdaten anzeigen

Studienlocations
(3 von 68)

Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
University of California - San Diego
92093 La Jolla
United StatesRekrutierend» Google-Maps
Angeles Clinic and Research Institute
90025 Los Angeles
United StatesRekrutierend» Google-Maps
University of California Davis Comprehensive Center
95817 Sacramento
United StatesRekrutierend» Google-Maps
Georgetown University Medical Center
20057 Washington
United StatesRekrutierend» Google-Maps
Houston Lee Moffitt Cancer Center & Research Institute
33612 Tampa
United StatesRekrutierend» Google-Maps
The University of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
John Theurer Cancer Center at Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-Maps
Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering
10065 New York
United StatesRekrutierend» Google-Maps
University of Oklahoma Peggy and Charles Stephenson Cancer Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Abramson Cancer Center of the University of Pennsylvania
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Thomas Jefferson University Hospital
19107 Philadelphia
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
University of Utah - Huntsman Cancer Institute
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
University of Washington - Fred Hutchinson Cancer Center
98109 Seattle
United StatesRekrutierend» Google-Maps
University of Wisconsin
53705 Madison
United StatesRekrutierend» Google-Maps
Scientia Clinical Research
2031 Randwick
AustraliaRekrutierend» Google-Maps
Melanoma Institute Australia (MIA) - The Poche Centre
2065 Wollstonecraft
AustraliaRekrutierend» Google-Maps
LKH - Universitätsklinikum der PMU Salzburg
5020 Salzburg
AustriaRekrutierend» Google-Maps
Universitair Ziekenhuis Brussel
1090 Jette
BelgiumRekrutierend» Google-Maps
Hospital Nossa Senhora da Conceicao
91350-200 Porto Alegre
BrazilRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2C4 Toronto
CanadaRekrutierend» Google-Maps
Gustave Roussy (Institut de Cancerologie Gustave-Roussy)
94805 Villejuif
FranceRekrutierend» Google-Maps
Universite Claude Bernard Lyon Est
69100 Lyon
FranceRekrutierend» Google-Maps
Hopital Saint-Louis - Centre d'Onco-Dermatologie
75010 Paris
FranceRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
00168 Rome
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Patologia Ostetrica e Ginecologica
00168 Seriate
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Yonsei University College of Medicine
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
University of Ulsan College of Medicine
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Netherlands Cancer Institute
1066 Amsterdam
NetherlandsRekrutierend» Google-Maps
UMC Groningen Comprehensive Cancer Center
9713 Groningen
NetherlandsRekrutierend» Google-Maps
New Zealand Clinical Research-Auckland
92697 Auckland
New ZealandRekrutierend» Google-Maps
Centrum Medyczne Pratia Poznan - Skorzewo
60-185 Skórzewo
PolandRekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
02-781 Warszawa
PolandRekrutierend» Google-Maps
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitario Vall dHebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid
28022 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Fundacion Jimenez Diaz
28040 Madrid
SpainRekrutierend» Google-Maps
University Hospital, Basel Switzerland
4031 Basel
SwitzerlandRekrutierend» Google-Maps
University Hospital of Zurich
8058 Zürich
SwitzerlandRekrutierend» Google-Maps
Sarah Cannon Research Institute UK
W1G6AD London
United KingdomRekrutierend» Google-Maps
University of Oxford
OX3 7LI Oxford
United KingdomRekrutierend» Google-Maps
The Beatson West of Scotland Cancer Centre
G12 0YN Glasgow
United KingdomRekrutierend» Google-Maps
University of Liverpool
L69 3BX Liverpool
United KingdomRekrutierend» Google-Maps
University College Hospital London
W1T7HA London
United KingdomRekrutierend» Google-Maps
The Christie NHS Foundation Trust
Manchester
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital
SM25PT Surrey Quays
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The IMC-F106C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable

tumors which include select Advanced Solid Tumors and will be conducted in two phases.

1. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose

(RP2D) of IMC-F106C as a single agent and administered in combination with

chemotherapies, targeted therapies, and monoclonal antibodies.

2. Phase 2: To assess the efficacy of IMC-F106C in selected advanced solid tumors.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. ECOG PS 0 or 1

2. HLA-A*02:01 positive

3. PRAME positive tumor

4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination

with standard therapies

5. If applicable, must agree to use highly effective contraception

Exclusion Criteria:

1. Symptomatic or untreated central nervous system metastasis

2. Recent bowel obstruction

3. Ongoing ascites or effusion requiring recent drainages

4. Significant immune-mediated adverse event with prior immunotherapy (patients in

checkpoint inhibitor combination treatment)

5. Inadequate washout from prior anticancer therapy

6. Significant ongoing toxicity from prior anticancer treatment

7. Out-of-range laboratory values

8. Clinically significant lung, heart, or autoimmune disease

9. Ongoing requirement for immunosuppressive treatment

10. Prior solid organ or bone marrow transplant

11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency

virus (HIV) infection

12. Significant secondary malignancy

13. Hypersensitivity to study drug or excipients

14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study

intervention

15. Pregnant or lactating

16. Any other contraindication for applicable combination partner based on local

prescribing information

Studien-Rationale

Primary outcome:

1. Phase 1: Incidence of dose-limiting toxicity (DLT)s (Time Frame - Up to ~28 days after each dose)

2. Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE) (Time Frame - Up to 30 days after the last dose of study therapy)

3. Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations (Time Frame - from first dose through last dose (anticipated for up to 12 months))

4. Phase 1: Number of participants with abnormal laboratory test results (hematology) (Time Frame - Up to 30 days after the last dose of study therapy)

5. Phase 1: Number of participants with abnormal laboratory test results (chemistry) (Time Frame - from first dose to 30 days after the last dose)

6. Phase 1: Number of participants with abnormal laboratory test results (coagulation) (Time Frame - from first dose to 30 days after the last dose)

7. Phase 1: Number of participants with abnormal urinalysis (Time Frame - from first dose to 30 days after the last dose)

8. Phase 1: Number of participants with abnormal vital signs (Time Frame - from first dose to 30 days after the last dose)

9. Phase 1: Mean change from baseline in QTcF interval (Time Frame - Up to 30 days after the last dose of study therapy)

10. Phase 2: Best overall response (BOR) (Time Frame - from first dose to approximately 2 years)

Secondary outcome:

1. Phase I: Best Overall Response (BOR) (Time Frame - from first dose to approximately 2 years)

2. Progression-free survival (PFS) (Time Frame - from first dose to approximately 2 years)

3. Duration of response (DOR) (Time Frame - from first dose to approximately 2 years)

4. Overall survival (Time Frame - from first dose to approximately 2 years)

5. Pharmacokinetics Area under the plasma concentration-time curve (AUC) (Time Frame - approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks))

6. Pharmacokinetics The maximum observed plasma drug concentration (Cmax) (Time Frame - approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks))

7. Pharmacokinetics The time to reach maximum plasma concentration (Tmax) (Time Frame - approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks))

8. Pharmacokinetics The elimination half-life (t1/2) (Time Frame - approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks))

9. Incidence of anti-IMC-F106C antibody formation (Time Frame - approximately 2 years)

10. Changes in lymphocyte counts over time (Time Frame - approximately 3 weeks)

11. Changes in serum cytokines over time (Time Frame - approximately 3 weeks)

12. Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria (Time Frame - approximately 2 years)

Studien-Arme

  • Experimental: IMC-F106C Monotherapy
    Participants receive IMC-F106C.
  • Experimental: IMC-F106C and Anti-PD(L)1 Agent
    Participants receive IMC-F106C and pembrolizumab.
  • Experimental: IMC-F106C and Chemotherapy
    Participants receive IMC-F106C and chemotherapy. Choice of chemotherapy is dependent on cohort.
  • Experimental: IMC-F106C and Targeted Therapy
    Participants receive IMC-F106C and a selected targeted therapy. Receipt of kinase inhibitor is dependent on histology.
  • Experimental: IMC-F106C and Multimodal Therapy
    Participants receive IMC-F106C, biologics (eg, pembrolizumab, bevacizumab) IV infusions and chemotherapy IV infusions based on histology.

Geprüfte Regime

  • IMC-F106C:
    IMC-F106C IV infusions
  • IMC-F106C and pembrolizumab:
    IMC-F106C and pembrolizumab IV infusions
  • IMC-F106C and chemotherapy:
    IMC-F106C and chemotherapy IV infusions
  • IMC-F106C and monoclonal antibodies and chemotherapy:
    IMC-F106C and a monoclonal antibody therapy and chemotherapy
  • IMC-F106C and tebentafusp:
    IMC-F106C and tebentafusp IV infusions
  • IMC-F106C and bevacizumab:
    IMC-F106C and bevacizumab IV infusions
  • IMC-F106C and kinase inhibitors:
    IMC-F106C and oral kinase inhibitors

Quelle: ClinicalTrials.gov


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