RECRUITING

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

Conditions

Colorectal Cancer Cholangiocarcinoma Appendiceal Adenocarcinoma Pancreatic Adenocarcinoma Gastric Adenocarcinoma Endometrial Adenocarcinoma Triple Negative Breast Cancer Ovarian Cancer Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

Quick Facts

Study Start:2024-06-18

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06399757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Apollo Therapeutics

CONTACT

781-479-2267

AP10@apollotx.com

Principal Investigator

Sanjay Aggarwal, MD

STUDY_CHAIR

Apollo Therapeutics Ltd

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618

United States

Florida Cancer Specialists & Research Institute

Sarasota, Florida, 34232

United States

Duke Cancer Institute

Durham, North Carolina, 27710

United States

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

United States

Mary Crowley Cancer Research

Dallas, Texas, 75251

United States

NEXT Oncology- San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Apollo Therapeutics Ltd

Sanjay Aggarwal, MD, STUDY_CHAIR, Apollo Therapeutics Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-18

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-06-18

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Cancer
Cholangiocarcinoma
Appendiceal Adenocarcinoma
Pancreatic Adenocarcinoma
Gastric Adenocarcinoma
Endometrial Adenocarcinoma
Triple Negative Breast Cancer
Ovarian Cancer
Prostate Cancer