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Trial Title:
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination
NCT ID:
NCT05525247
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Gemcitabine
Conditions: Keywords:
IL-2
IL-2/anti-IL-2(TCB2) conjugate
SLC-3010
Immuno-oncology
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SLC-3010
Description:
Intravenous (IV) infusion over 30 minutes on day 1 of each 21-day cycle
Arm group label:
Gemcitabine combination
Arm group label:
Monotherapy
Intervention type:
Combination Product
Intervention name:
Gemcitabine
Description:
1000 ㎎/㎡ IV infusion over 30 minutes on day 1 and 8 of each 21-day cycle
Arm group label:
Gemcitabine combination
Summary:
This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study,
evaluating the safety, tolerability, pharmacokinetic, preliminary anti-tumor activity,
and effects on pharmacodynamic markers following administration of SLC-3010 as
monotherapy and in combination with gemcitabine, in patients with various advanced solid
tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients must meet all the following inclusion criteria to be eligible for enrollment
into the study:
1. Histologically or cytologically-documented solid tumors that are inoperable locally
advanced, metastatic, or recurrent:
- Part 1 Dose Escalation: Patients with any solid tumor who have progressed on or
are intolerant to standard therapy, for which no standard therapy is available,
or who decline standard therapy.
- Part 2: Dose Expansion: Patients must have received at least one prior line of
standard therapy in recurrent/metastatic setting and for whom standard
life-prolonging therapies are either not available or are not qualified to
receive such therapies. Additional general and tumor specific inclusion and
exclusion criteria will apply.
2. Patients who have at least one measurable lesion, as defined by RECIST v1.1.
3. Adult male or female patients ≥18 years of age on day of signing the informed
consent form (ICF) or follow local regulatory requirement if the legal age for
consenting for study participation is more than 18 years.
4. Patients who are able and willing to provide written informed consent and are
willing and able to comply with all study procedures.
5. Patients with life expectancy of ≥3 months.
6. Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0
or 1.
7. Patients who demonstrate adequate organ function as defined.
8. Resolution of any clinically significant toxic effects of prior therapy to Grade 0
or 1 according to the NCI CTCAE v5.0 (exception of alopecia and other AEs that are
acceptable in the opinion of the Investigator and after discussion with the Medical
Monitor)
9. Willingness of male and female patients of reproductive potential to observe
conventional and effective birth control methods with failure rates of <1% for the
duration of treatment and for 3 months (6 months for female patients administering
gemcitabine) following the last dose of study treatment. This must include barrier
methods such as condom or diaphragm with spermicidal gel. Women of childbearing
potential (WOCBP) are defined as following menarche and who are not postmenopausal
(and 2 years of nontherapy-induced amenorrhea or surgically sterile). For male
patients with a nonpregnant female partner of childbearing potential and a WOCBP, 1
of the following highly effective birth control methods, with a failure rate of less
than 1% per year when used consistently and correctly, is recommended:
1. Combined estrogen and progestin containing hormonal contraception associated
with inhibition of ovulation given orally, intravaginally, or transdermally
2. Progestin-only hormonal contraception associated with inhibition of ovulation
given orally, by injection, or by implant
3. Intrauterine device
4. Intrauterine hormone-releasing system
5. Bilateral tubal occlusion/ligation
6. Vasectomized partner
7. Sexual abstinence Note: 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 drug. 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.
Birth control methods unacceptable for this study include the following:
1. Periodic abstinence (calendar, symptom-thermal, or post-ovulation methods)
2. Withdrawal (coitus interruptus)
3. Spermicide only
4. Lactational amenorrhea method
5. Sperm donation is prohibited during the duration of participation on this
protocol and for 90 days after the last dose of study drug
10. WOCBP must have a documented negative serum or urine pregnancy at screening within 3
calendar days before the first dose of study drug. Females who are not of
childbearing potential must have documented:
1. Postmenopausal status, defined as cessation of regular menses for at least 12
months and documented serum follicle stimulating hormone (FSH) levels that are
within laboratory reference range for postmenopausal women, or
2. Have undergone a documented hysterectomy or bilateral oophorectomy, or
3. Have medically confirmed ovarian failure.
Exclusion Criteria:
Individuals who meet any of the following exclusion criteria will not be eligible to
participate:
1. Prior history of or active malignant disease other than that being treated in this
study.
Exceptions: (i) Malignancies that were treated curatively and have not recurred
within the past 2 years, or (ii) Completely resected basal cell carcinoma and
squamous cell carcinoma of the skin, or (iii) Completely resected carcinoma in situ
of any type.
2. Known brain metastases or cranial epidural disease unless adequately treated with
radiotherapy and/ or surgery (including radiosurgery) and stable for at least 4
weeks before first dose of study drug. Note: patients with an incidental finding of
an isolated lesion <1 cm in diameter may be eligible if the lesion does not require
treatment per investigator judgment. Eligible patients must be neurologically
asymptomatic and without corticosteroids treatment for at least 2 weeks prior to
start of first dose of study treatment.
3. Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy, or any
immunosuppressive therapy within 7 days prior to first dose of study drug. Topical
( 480 msec at
screening
2. History of myocardial infarction, acute coronary syndrome or coronary
angioplasty/stenting/bypass grafting within the last 6 months
3. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or
history of CHF NYHA class III or IV
9. Patients exhibiting significant respiratory symptoms, those with suspected or known
serious or severe respiratory conditions and those requiring supplemental oxygen at
screening.
10. Receipt of any type of systemic anticancer therapy (including investigational
therapy) within 3 weeks before the first dose of study drug or 5 times elimination
half-life of drug, if known, has passed whatever is shorter.
11. Is currently participating in or has participated in an interventional clinical
trial with last dose of the investigational compound or device within 3 weeks of the
first dose of treatment in this current trial. Patients who are in survival follow
up can be enrolled if the last dose was 3 weeks earlier.
12. Radiation within 2 weeks before first dose of study treatment. Patients with
clinically relevant ongoing complications from prior RT are not eligible.
13. Major surgery within 2 weeks prior to study drug administration; patients must have
recovered adequately from toxicity and/ or complications per investigator
discretion.
14. Receipt of any live vaccines within 4 weeks prior to first dose of study drug.
15. Receipt of non-live COVID-19 vaccine within 7 days prior to DLT evaluation because
vaccine related toxicities could interfere safety assessment.
16. Any prior treatment with IL-2 based drug.
17. Has a known hypersensitivity to the components of the study therapy or its analogs.
18. Has a history or current evidence of any condition therapy, lab abnormality or other
circumstance that might expose the patient to risk by participating in the trial,
confound the results of the trial, or interfere with the patient's participation for
the full duration of the trial.
19. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial
20. For women only: pregnant or breastfeeding
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Selecxine Investigator site
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Brentwood
Zip:
6153
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Gyeonggi-do
Zip:
13620
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Selecxine Investigator site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Start date:
December 21, 2022
Completion date:
January 2028
Lead sponsor:
Agency:
Selecxine
Agency class:
Industry
Source:
Selecxine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05525247
