First-in-human study of ICT01 in patients with advanced-stage, relapsed/refractory cancer
- Conditions
- Relapsed/refractory solid tumors or hematological cancersMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003847-31-DE
- Lead Sponsor
- ImCheck Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 409
The following criteria must be checked over the screening period and at baseline. ALL inclusion criteria must be met to include the subject in the study:
Part1 and Part2:
1) Male or female aged =18 years
2) Voluntarily signed written informed consent
3) Patients with histologically or cytologically confirmed diagnosis of
advanced cancer including:
a.Group A: Relapsed/refractory advanced bladder, breast, colorectal,
gastric, melanoma, ovarian, prostate and PDAC
b.Group B: Relapsed/refractory advanced hematologic malignancies
including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse
large B cell lymphoma and follicular lymphoma
c.Group C: Relapsed/refractory advanced melanoma, bladder, head and
neck SCC, and non small cell lung cancer (approved indications in the US
& EU for pembrolizumab)
d.Group D: persistent or recurrent advanced epithelial ovarian cancer,
primary fallopian or primary peritoneal cancer;
e.Group E: mCRPC patients who failed prior androgen deprivation
therapy. Patients may have also failed prior taxane therapy.
f.Group F: Newly diagnosed AML, by WHO 2022 criteria, in patients who
are indicated to start treatment with VEN/AZA
g.Group G: metastatic or unresectable melanoma with primary
resistance following at least 6 weeks of prior CPI treatment for advanced
disease, defined as best response of progressive disease or SD of short
duration (lasting less than 6 months),
h.Group H: locally advanced or metastatic urothelial carcinoma who are
not eligible for any platinum-containing chemotherapy, or who have
disease progression during or following platinum-containing
chemotherapy or within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy.
i. Group I: metastatic or unresectable, recurrent HNSCC in patients who
failed first-line immunotherapy or for whom immunotherapy was
contraindicated, or in patients who failed 2 prior systemic regimens
including an immunotherapy.
4) Willingness to undergo Screening, baseline, and on-study tumor
biopsies or BMAs, as applicable;
5) ECOG performance status = 1 (expect for Group F)
6) Life expectancy > 3 months
7)Clinical labs:
a. Hematology:
- Hemoglobin =8.5 g/dL
- All Groups except Group B and F:
• platelet count =75 × 109/L;
• lymphocyte count =0.5 × 109/L;
• absolute neutrophil count =1.0 × 109/L;
b. Liver enzymes:
- AST and ALT =2.5 × upper limit of normal (ULN) (<5 × ULN in the case
of liver metastases);
- bilirubin =1.5 × ULN (<2 × ULN in case of liver metastases);
c. Renal function:
- serum creatinine <1.5 × ULN
8) Adequate Contraceptives measures for males and women of
childbearing potential
9) Women must not be breastfeeding
10) At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
11)Part 1: Patients must have no available standard of care or available
treatment with potential survival benefit for their disease, as determined
by the treating Investigator
12) in Groups C, G, H, and I must meet the eligibility criteria in the
approved package labeling of pembrolizumab and meet the following
conditions:
a. Must not be first-line patients (i.e., must meet Inclusion Criteria #11)
b. Must not have any history or ongoing interstitial lung disease
c. Must not have undergone prior anterior organ transplantation,
including allograft stem cell transplantation
Part 2:
13)Replaces inclusion criterion #11 (all groups excepeted group F):
Patients mus
The following criteria must be checked during the screening period and
at baseline. If ANY exclusion criterion applies, the subject must not be
included in the study:
1) Any malignancy of ?9d2 T cell origin
2) Any anti-tumor-directed drug therapy within 28 days or 5 times the
elimination half-life (whichever is shorter) before study treatment (does
not apply to patients receiving pembrolizumab for the combination
arms)
3) Treatment with investigational drugs within 28 days before study
treatment
4) Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of
dexamethasone or equivalent, for the last 28 days and ongoing
5) Patients with rapidly progressing disease defined as
advanced/metastatic, symptomatic, visceral spread, with a risk of lifethreatening
complications in the short term (e.g., during Screening
Period/ treatment washout) that includes patients with massive
uncontrolled effusions pleural, pericardial, peritoneal, pulmonary
lymphangitis, and over 50% liver involvement
6) Ongoing immune-related adverse events (irAEs) and/or AEs =grade 2
from previous therapies except vitiligo, stable neuropathy up to grade 2,
hair loss, and stable endocrinopathies with substitutive hormone
therapy.
7)Within 4 weeks of major surgery
8) Documented history of active autoimmune disorders requiring
systemic immunosuppressive therapy within the last 12 months
9) Primary or secondary immune deficiency
10)Active and uncontrolled infections requiring intravenous antibiotic or
antiviral treatment
11) Known/suspected hypersensitivity against ICT01, human or
humanized IgGs, PD-1/PD-L1 blockers or their ingredients
12) Seropositive (except after vaccination or confirmed cure for
hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus
(HBV), or hepatitis C virus (HCV), Patients positive for HIV can be
eligible if cluster of differentiation (CD)4+ T-cell counts =350 cells and
have no history of AIDS-defining opportunistic infections in the past 12
months, as deemed appropriate by the Investigator;
13) Clinically significant cardiac disease including heart failure (New
York Heart Association, Class III or IV), pre-existing arrhythmia,
uncontrolled angina pectoris, or myocardial infarction within 1 year
before study entry
14) Dementia or altered mental status that would prohibit informed
consent
15) Other severe, acute, or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with study
assessed by the Investigator
16) Active drug or alcohol abuse as assessed by the Investigator
17) Patients with uncontrolled and symptomatic brain metastases.
Patient with asymptomatic brain metastases are allowed provided they
are stable and off therapeutic steroids for at least 4 weeks.
Group F Specific Exclusion Criteria all above apply align with VIALE-A
trial (DiNardo et al. 2020)
18)Patients with t(15;17), t(8;21), inv(16), or t(16;16) karyotypic
abnormality.
19)Participant has history of myeloproliferative neoplasm (MPN)
including myelofibrosis, essential thrombocythemia, polycythemia vera,
chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation
and AML with BCR-ABL1 translocation.
20) Patient has a white blood cell count >25 x 10?/L. In EU and
UK:Hydroxyurea, and/or cytarabine (up to 1 g total) is permitted to
meet this criterion.
21)Patients with known symptomatic or uncontrolled CNS leukemia.
22)Any previous or concomitant malignancy, except when the patient
has completed definit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method