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

Select Advanced Solid Tumors Clinical Trial

Official title:

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262466
• Other study ID #: IMC-F106C-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 25, 2020
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Immunocore Ltd
• Contact: Immunocore Medical Information
• Phone: 844-466-8661
• Email: medical.information[@]immunocore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 727
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Select Advanced Solid Tumors

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	Scientia Clinical Research	Randwick	New South Wales
Australia	Melanoma Institute Australia (MIA) - The Poche Centre	Wollstonecraft	New South Wales
Austria	LKH - Universitätsklinikum der PMU Salzburg	Salzburg
Belgium	Institut Jules Bordet	Bruxelles
Belgium	UZA	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liege	Liège	Luik
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre
Canada	CHUM Centre de Recherche	Montréal	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
France	Universite Claude Bernard Lyon Est	Lyon	Villeurbanne
France	Hopital Saint-Louis - Centre d'Onco-Dermatologie	Paris
France	Gustave Roussy (Institut de Cancerologie Gustave-Roussy)	Villejuif	Val De Marne
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Italy	Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale	Napoli
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche	Rome	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Patologia Ostetrica e Ginecologica	Seriate	Roma
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	University of Ulsan College of Medicine	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul
Netherlands	Netherlands Cancer Institute	Amsterdam	CX
Netherlands	UMC Groningen Comprehensive Cancer Center	Groningen	GZ
Netherlands	Leiden UMC	Leiden	ZA
New Zealand	New Zealand Clinical Research-Auckland	Auckland
Poland	Centrum Medyczne Pratia Poznan - Skorzewo	Skórzewo
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa
Spain	Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitario Vall dHebron	Barcelona
Spain	NEXT Barcelona	Barcelona
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid	Madrid
Spain	Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona	Pamplona	Navarra
Switzerland	University Hospital, Basel Switzerland	Basel
Switzerland	University Hospital of Zurich	Zürich
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	University of Liverpool	Liverpool
United Kingdom	Sarah Cannon Research Institute UK	London	City Of London
United Kingdom	University College Hospital London	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	University of Oxford	Oxford	Oxfordshire
United Kingdom	Royal Marsden Hospital	Surrey Quays
United States	University of Colorado	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Prisma Health	Greenville	South Carolina
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of California - San Diego	La Jolla	California
United States	Angeles Clinic and Research Institute	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan Kettering	New York	New York
United States	University of Oklahoma Peggy and Charles Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	University of California Davis Comprehensive Center	Sacramento	California
United States	University of Utah - Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of Washington - Fred Hutchinson Cancer Center	Seattle	Washington
United States	Houston Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Immunocore Ltd

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Incidence of dose-limiting toxicity (DLT)s		Up to ~28 days after each dose
Primary	Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)		Up to 30 days after the last dose of study therapy
Primary	Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations		from first dose through last dose (anticipated for up to 12 months)
Primary	Phase 1: Number of participants with abnormal laboratory test results (hematology)		Up to 30 days after the last dose of study therapy
Primary	Phase 1: Number of participants with abnormal laboratory test results (chemistry)		from first dose to 30 days after the last dose
Primary	Phase 1: Number of participants with abnormal laboratory test results (coagulation)		from first dose to 30 days after the last dose
Primary	Phase 1: Number of participants with abnormal urinalysis		from first dose to 30 days after the last dose
Primary	Phase 1: Number of participants with abnormal vital signs		from first dose to 30 days after the last dose
Primary	Phase 1: Mean change from baseline in QTcF interval		Up to 30 days after the last dose of study therapy
Primary	Phase 2: Best overall response (BOR)		from first dose to approximately 2 years
Secondary	Phase I: Best Overall Response (BOR)		from first dose to approximately 2 years
Secondary	Progression-free survival (PFS)		from first dose to approximately 2 years
Secondary	Duration of response (DOR)		from first dose to approximately 2 years
Secondary	Overall survival		from first dose to approximately 2 years
Secondary	Pharmacokinetics Area under the plasma concentration-time curve (AUC)		approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks)
Secondary	Pharmacokinetics The maximum observed plasma drug concentration (Cmax)		approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks)
Secondary	Pharmacokinetics The time to reach maximum plasma concentration (Tmax)		approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks)
Secondary	Pharmacokinetics The elimination half-life (t1/2)		approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks)
Secondary	Incidence of anti-IMC-F106C antibody formation		approximately 2 years
Secondary	Changes in lymphocyte counts over time		approximately 3 weeks
Secondary	Changes in serum cytokines over time		approximately 3 weeks
Secondary	Local tumor response based on Gynecological Cancer Intergroup (GCIG) Cancer Antigen 25 (CA-125) response criteria		approximately 2 years