A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)
- Conditions
- breast cancerhead and neck cancerSkin cancer1002765510040900
- Registration Number
- NL-OMON51302
- Lead Sponsor
- Cytovation ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 12
General Inclusion Criteria
Patients who meet all of the following criteria will be eligible to participate
in the study:
1. Are 18 years of age or older on the day of signing informed consent;
2. Provide written informed consent and are able to comply with study
procedures and assessments;
3. Have measurable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) version (v)1.1 as assessed by the local site Investigator/radiology.
Lesions situated in a previously irradiated area are considered measurable if
progression has been demonstrated in such lesions;
4. Have at least 1 non-ulcerated, measurable, and accessible lesion for
intra-tumoral (IT) injection with a maximum diameter of 5 cm;
5. Are able to provide tissue from a core or excisional biopsy at screening or
have an acceptable stored tumor sample available that was collected within 90
days prior to screening;
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
1;
7. Have a life expectancy *3 months, as determined by the Investigator;
8. Female patients of non-childbearing potential must be either surgically
sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or
bilateral oophorectomy at least 26 weeks before screening), post-menopausal,
defined as spontaneous amenorrhea for at least 2 years, or with
follicle-stimulating hormone in the post-menopausal range at screening;
9. Female patients of childbearing potential (defined as <2 years after last
menstruation or not surgically sterile) must have a negative serum pregnancy
test at screening and agree to use a highly effective method for contraception
from the time of signing the informed consent form (ICF) until at least 120
days after the last administration of study treatment. Highly effective methods
of contraception are birth control methods with a failure rate of <1% per year
when
used consistently and correctly, including the following:
o Combined estrogen- and progestin-containing hormonal contraception associated
with inhibition of ovulation given orally, intravaginally, or transdermally;
progestin-only
hormonal contraception associated with inhibition of ovulation given orally, by
injection,
or by implant; intrauterine devices; and intrauterine hormone-releasing
systems;
o Female sterilization (surgical bilateral oophorectomy with/without
hysterectomy, total hysterectomy, bilateral tubal occlusion/ligation) at least
26 weeks prior to first study
treatment;
o Sterilization of male partner (at least 6 months prior to first study
treatment dose); and
o Complete sexual abstinence. Periodic abstinence (eg, calendar) and withdrawal
are not acceptable. Sexual abstinence is considered a highly effective method
only if defined as refraining from heterosexual intercourse during the entire
period of risk associated with the study treatment. The reliability of sexual
abstinence needs to be evaluated in relation to the duration of the study and
the preferred and usual lifestyle of the patient.
10. Male patients able to father children must agree to use 2 acceptable
methods of contraception throughout the study (eg, condom plus spermicidal
gel). Sperm donation is not recommended from the time of signing the ICF until
at least 120 days after the last administration of study
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from
participation in the study:
1. Have only non-palpable cutaneous infiltrations (eg, breast cancer cutaneous
carcinomatosis);
2. Have had anti-cancer therapy within 4 weeks prior to the first dose of study
treatment (2 weeks for palliative radiotherapy);
Note: Patients must have recovered from all adverse events (AEs) due to
previous therapies to <= Grade 1 or baseline (alopecia is an allowable
exception). Upon discussion with the Sponsor, patients with <= Grade 2
neuropathy or endocrine-related AEs requiring treatment or hormone replacement
may be eligible.
Note: If the patient had major surgery, the patient must have recovered
adequately from the
procedure and/or any complications from the surgery prior to starting study
intervention.
3. Have participated in a clinical trial and received an investigational
therapy within 30 days prior to the first dose of study treatment;
4. Have received or will receive a live or live attenuated vaccine within 30
days prior to the first dose of study treatment;
Note: Seasonal flu vaccines that do not contain live vaccine are permitted.
Coronavirus Disease 2019 (COVID-19) vaccines are only permitted with
documentation of the date of the vaccine if the last dose of vaccine was
administered >14 days prior to the first dose of study treatment. The COVID-19
booster vaccine must be administered at least 14 days prior to the first dose
of study treatment and is not allowed during the first 3 months of the
Treatment Period.
5. Have tested positive for severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infection within 14 days prior to the Screening Visit;
Note: Patients who have had a known SARS-CoV-2 infection >14 days prior to the
Screening Visit are permitted at Investigator discretion and must present with
no symptoms.
6. Have had a major surgical procedure within 14 days prior to the first dose
of study treatment;
7. Are expected to require a systemic or localized anti-neoplastic therapy
during participation in
this study, excluding localized palliative radiotherapy to tumors not selected
for evaluation of treatment response;
Note: Use of denosumab for patients with bone metastasis is allowed.
8. Are pregnant or breastfeeding;
9. Have clinical evidence of a secondary malignancy actively progressing or
requiring active treatment other than curative therapies for early stage
(carcinoma in situ or Stage 1) carcinomas or non-melanoma skin cancer;
10. Have had any autoimmune disease requiring immunosuppressive therapy (ie,
use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
within 2 years prior to the first dose of study treatment;
Note: Replacement therapy (eg, thyroxine, insulin, or physiologic
corticosteroid replacement therapy for adrenal or pituitary insufficiency) is
not considered a form of systemic treatment and is allowed.
11. Have a condition requiring continuous systemic treatment with either
corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive
agents within 2 weeks prior to the first dose of study treatment. Inhaled,
intranasal, or topical (only on areas outside the injected lesion[s]) and
physiological replacement doses of up to 10 mg dai
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase 1b<br /><br>• Incidence, frequency, and seriousness of treatment-emergent adverse events<br /><br>(TEAEs);<br /><br>• Incidence of dose-limiting toxicity (DLTs); and<br /><br>• Changes from baseline in vital signs, body weight, 12 lead ECG parameters,<br /><br>and laboratory assessments.<br /><br><br /><br>Phase 2a<br /><br>Objective response rate (ORR) based on radiological assessment according to<br /><br>Response Evaluation Criteria in Solid Tumor (RECIST) v1.1</p><br>
- Secondary Outcome Measures
Name Time Method