A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors

Launched by APOLLO THERAPEUTICS LTD · May 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called APL-5125 for adults with advanced solid tumors, specifically focusing on types like colorectal cancer, pancreatic cancer, and triple-negative breast cancer, among others. The main goals are to see if APL-5125 is safe, well-tolerated, and effective for patients whose cancer has either spread or cannot be surgically removed. The trial is currently recruiting participants who are at least 18 years old and have specific types of cancer that have not responded to standard treatments.

To participate, individuals must meet certain criteria, such as having a confirmed diagnosis of one of the targeted cancers and being unable to receive standard treatment options. Participants should also be in relatively good health and able to provide informed consent. Throughout the trial, participants will receive APL-5125 and will be monitored for its effects on their cancer and any side effects they may experience. It's essential that potential participants discuss any underlying health issues or medications with their doctor to determine if they are suitable for this study.

Gender

ALL

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 Cycle 1 Day 1, 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