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New treatment option for Colorectal Cancer
Official title A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06399757
What this study is testing
What is APL-5125?
APL-5125 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years or older
- Phase 1: Histologically confirmed locally advanced, inoperable, or metastatic tumor; Colorectal carcinoma, Cholangiocarcinoma, Appendiceal...
- For Phase 1 sub-studies: Colorectal carcinoma, Cholangiocarcinoma, Appendiceal adenocarcinoma, Pancreatic Adenocarcinoma, Gastric Adenocarcinoma...
- 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...
You likely can't join if
- Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically...
- Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active...
- 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
See the full eligibility 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...
- 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...
- 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
- Certain medical conditions such as: active brain metastases, carcinomatous meningitis, unstable angina pectoris, myocardial infarction or clinically significant ventricular arrhythmias, symptomatic congestive heart...
- Certain prior therapies such as: anti-cancer treatment within 2 weeks of Cycle 1 Day 1, prior radiotherapy within 14 days before screening, active anti-coagulation therapy, over the counter or prescription medications...
- 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:
- Aspartate aminotransferase and/or alanine aminotransferase (ALT) \>3 × upper limit of normal (ULN) (\>5 x ULN for people with liver metastases)
- Total bilirubin \>1.5 × ULN (except participants with Gilbert's syndrome).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Sarasota, Florida, United States
- Ann Arbor, Michigan, United States
- Durham, North Carolina, United States
- Huntersville, North Carolina, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Sarasota, Florida, United States; Ann Arbor, Michigan, United States; Durham, North Carolina, United States; Huntersville, North Carolina, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.