Trial Title:
A Phase 1/2 Study of SMP-3124LP in Adults with Advanced Solid Tumors
NCT ID:
NCT06526819
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
first in human
open label
platinum-resistant ovarian cancer (PROC)
Triple Negative Breast Cancer (TNBC)
Metastatic squamous cell carcinoma of the anus (MSCCA)
Squamous cell carcinoma of the head and neck (SCCHN)
non-small cell lung cancer (NSCLC)
uterine serous cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SMP3124LP
Description:
Liposomal encapsulation formulation of SMP-3124
Arm group label:
Part 1 - Dose Escalation & Dose Optimization
Arm group label:
Part 2 - Dose Expansion
Summary:
An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety,
Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid
Tumors
Detailed description:
Phase 1/2, global, multicenter, open-label, first-in-human, clinical study to evaluate
the safety, tolerability, pharmacokinetics and preliminary antitumor activity of SMP-3124
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically-confirmed cancer that is advanced, recurrent, or
metastatic with the following origins, and whose disease progressed on standard
therapy and for whom there are no alternative therapies that may confer overall
survival benefit.
For patients in the Dose Escalation part:
1. Platinum-resistant ovarian cancer
- Histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer,
with predominantly high-grade (Grade 2 or 3) epithelial features (serous and
clear cell)
- Platinum resistant is defined as relapsed within 6 months after the last dose
of platinum-based therapy
2. Triple negative breast cancer - ER- and PR-negative with HER2 negative
- HER2 negative is defined as one of the following: 0 or 1+ by IHC, or if IHC 2+,
then in situ hybridization is negative per the ASCO-CAP HER2 guidelines
- ER- and PR-negative is defined as < 10% of cells expressing hormonal receptors
by IHC, as per standard guidelines
3. Squamous cell carcinoma of the anus
- Patient with locally advanced ineligible for surgery is allowed.
4. Squamous cell carcinoma of the head and neck
5. Non-small cell lung cancer (NSCLC: adenocarcinoma, large cell, and squamous cell
carcinoma)
6. Uterine serous cancer (recurrent or persistent)
For Patients in the Dose Expansion Part:
7. Cohort A: PROC (same as above)
8. Cohort B: TNBC (same as above)
9. Cohort C: SCCA (same as above)
- ECOG performance /= 9 g/dL (transfusion or use of erythropoietin to obtain this are not
permitted) b. Absolute neutrophil count >/= 1500 uL (platelet transfusion not allowed to
achieve this) c. Platelet count >/= 100 x 10 (platelet transfusion not alled to achieve
this) d. Bilirubin /= 60 mL/min using Cockcroft-Gault formula
- Patient is non-fertile or agrees to use adequate methods of contraception or agrees
to refrain completely from heterosexual intercourse during the study and for 6
months (for female and male patients alike) after the last dose of study
intervention.
- May be HIV positive if the following conditions are met:
1. CD4 + T-cell count >/= 350 cells/uL
2. HIV viral load < 400 copies/ml prior to enrollment
3. No history of acquired immunodefficiency syndrome (AIDS) defining opportunistic
infections
- Known hepatitis B infection mush have negative serum HbsAg. Patients with known
hepatitis C virus infection must have a viral load below the limit of quantification
Japan sites only: HBc antibody or HBsantibody tests should be performed if HBsAg is
negative. If HBc antibody or HBs antibody tests are positive, HBV DNA quantitative
tests should be performed to confirm that HBV DNA is negative.
Exclusion Criteria:
- Patient has received prior treatment at any time with a cell cycle checkpoint
inhibitor (eg, CHK1 and/or CHK2, WEE1, or ATR inhibition)
- Patient has a known allergy or sensitivity to any component of SMP-3124LP, including
the inactive ingredients
- Patient has received treatment with systemic anticancer therapy, radiotherapy, or
investigational therapy within 14 days prior to Study Cycle 1 Day 1. (Palliative
radiotherapy with a limited field of radiation within 2 weeks will be permitted.)
- Patient has undergone a major surgical procedure ≤ 28 days, or minor surgical
procedure ≤ 7 days, prior to Cycle 1 Day 1
- Patient has used strong CYP1A2 or 2D6 inhibitors within 14 days or 5 half-lives,
whichever occurs first, prior to Cycle 1 Day 1 (examples of restricted CYP1A2 and
CYP2D6, P-gp, and/or BCRP inducers, inhibitors, or substrates are presented in Table
16)
- Patient has central nervous system metastasis or leptomeningeal disease
- Prior or concurrent malignancy whose natural history or treatment would have a
significant potential to interfere with the safety or efficacy assessments of the
investigational regimen
- Patient has an abnormal ECG that is clinically significant, including a corrected QT
interval (corrected using Fridericia's correction formula [QTcF]) > 470 msec; and/or
a history of Torsade de Pointes
- Patient has a left ventricular ejection fraction < 45% by echocardiogram (ECHO)
- Patient has clinically significant cardiac disease including heart failure (eg, New
York Heart Association, Class III or IV)
- Patient has an active, uncontrolled, bacterial, viral, or fungal infection requiring
parenteral antimicrobial within 1 weeks prior to Cycle 1 Day 1
- Patient is pregnant (as evidenced by a positive serum or urine pregnancy test) or is
breastfeeding. Female breastfeeding patients may be enrolled if they interrupt
breastfeeding. Breastfeeding should not be resumed for at least 6 months after the
last dose of study drug.
For sites in Japan only: In addition to the above, any patient deemed likely to be
pregnant based on medical interview will be excluded from the study.
- Patient with ovarian cancer
1. Has a history of bowel obstruction related to their underlying disease within 3
months prior to Study Day 1
2. Has platinum-refractory disease. Platinum refractory is defined as progression
during platinum-based chemotherapy
- Patient has any other medical or psychiatric condition that, in the opinion of the
investigator, might interfere with their participation in the trial or interfere
with the interpretation of trial results
- Patient is taking a prohibited medication at baseline.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute at HealthOne
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Gerald Falchook, MD
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Margaret Gatti-Mays, MD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Timothy Yap, MD
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Kenichi Harano, MD
Email:
kharano@east.ncc.go.jp
Contact backup:
Last name:
Kenichi Harano, MD
Start date:
August 14, 2024
Completion date:
May 2029
Lead sponsor:
Agency:
Sumitomo Pharma America, Inc.
Agency class:
Industry
Source:
Sumitomo Pharma America, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06526819
