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Trial Title:
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
NCT ID:
NCT06399757
Condition:
Colorectal Cancer
Cholangiocarcinoma
Appendiceal Adenocarcinoma
Pancreatic Adenocarcinoma
Gastric Adenocarcinoma
Endometrial Adenocarcinoma
Triple Negative Breast Cancer
Ovarian Cancer
Prostate Cancer
Conditions: Official terms:
Adenocarcinoma
Triple Negative Breast Neoplasms
Cholangiocarcinoma
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:
APL-5125
Description:
APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
Arm group label:
Phase 1: Dose Escalation
Arm group label:
Phase 2: Dose Expansion/Optimization
Summary:
This is an open-label, Phase 1/2 study to determine the safety, tolerability, and
efficacy of APL-5125 for the treatment of selected locally advanced or metastatic solid
tumors with particular focus on Colorectal carcinoma (CRC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years or older
- Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor;
Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma.
- For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal
adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Endometrial
Adenocarcinoma, Triple Negative Breast Cancer, Ovarian Cancer, Prostate Cancer
- Phase 2: Colorectal carcinoma
- No available standard of care therapy or participant is ineligible for standard of
care therapy, except in CRC tumor type in which participant must have previously
received all the following therapeutic agents:
- fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
- an anti-VEGF therapy
- if wt-RAS (wt-KRAS and wt-NRAS), an anti-EGFR therapy
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Body Weight ≥40 kg.
- Female participants of childbearing potential must have negative serum pregnancy
test at screening; must not plan to become pregnant or have ova harvested or
breastfeed while on study; must be willing to use specific contraception or avoid
intercourse
- Male participants must be willing to use specific contraception and not plan to
impregnate a female partner or donate sperm while on study
- Participant must be willing and able to provide written informed consent and to
comply with the requirements of the trial
Exclusion Criteria:
- Certain medical conditions such as: active brain metastases, carcinomatous
meningitis, unstable angina pectoris, myocardial infarction or clinically
significant ventricular arrhythmias, symptomatic congestive heart failure,
uncontrolled active infection, history of significant hemorrhage within 4 weeks of
the first dose date, intestinal disease or major gastric surgery, arterial
thrombosis within 6 months of screening
- Certain prior therapies such as: anti-cancer treatment within 2 weeks of screening,
prior radiotherapy within 14 days before screening, active anti-coagulation therapy,
over the counter or prescription medications within 14 days or 5 half-lives prior to
cycle 1 day 1, herbal medicines and supplements within 14 days
- Major surgery within 1 month of screening
- Hemoglobin < 9.0 g/dL
- Absolute neutrophil count < 1.5 x 10^9/L
- Platelet count < 100 x 10^9/L
- Hepatic function:
1. Aspartate aminotransferase and/or alanine aminotransferase (ALT) >3 × upper
limit of normal (ULN) (>5 x ULN for subjects with liver metastases)
2. Total bilirubin >1.5 × ULN (except participants with Gilbert's syndrome).
3. Albumin < 3 g/dL
- Calculated or measured creatinine clearance of <60 mL/minute calculated using the
formula of Cockcroft and Gault ([140 - Age] × Mass [kg] / [72 × serum creatinine
mg/dL]). Multiply result by 0.85 if female.
- Fridericia's corrected QT interval (QTcF) >470 msec or a family history of Long QT
Syndrome.
- Cardiac function: Echocardiogram (or MUGA) showing Left Ventricular Ejection
Fraction (LVEF) <45% at rest
- Infectious diseases: positive for HIV (unless controlled with active retroviral
therapy), hepatitis B and hepatitis C
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Orange County Lennar Foundation Cancer Center
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists & Research Institute
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Carolina BioOncology Institute
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology- San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Start date:
June 18, 2024
Completion date:
May 2027
Lead sponsor:
Agency:
Apollo Therapeutics Ltd
Agency class:
Industry
Source:
Apollo Therapeutics Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06399757
