A Study To Investigate APL-5125 In Adults With Advanced Solid Tumors

Study Overview

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

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).

N/A

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

DRUG: APL-5125

AP10CP01

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	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-14
First Submitted that Met QC Criteria 2024-05-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-18
First Posted (ACTUAL) 2024-05-06	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1: Dose Escalation Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose. Possibility to expand into select populations	DRUG: APL-5125 APL-5125 is an oral drug (capsule) taken daily in 28-day cycles
EXPERIMENTAL: Phase 2: Dose Expansion/Optimization At least 2 dose levels of APL-5125 in a selected population	DRUG: APL-5125 APL-5125 is an oral drug (capsule) taken daily in 28-day cycles

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Phase 1: Dose Escalation

Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose. Possibility to expand into select populations

DRUG: APL-5125

APL-5125 is an oral drug (capsule) taken daily in 28-day cycles

EXPERIMENTAL: Phase 2: Dose Expansion/Optimization

At least 2 dose levels of APL-5125 in a selected population

DRUG: APL-5125

APL-5125 is an oral drug (capsule) taken daily in 28-day cycles

Primary Outcome Measures	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events [Safety]	Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results.	Through study completion, approximately one year
Incidence of dose limiting toxicities [Tolerability] (Phase 1)	Evaluation of tolerability parameters including dose limiting toxicities as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs and electrocardiogram results	Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)
Determine Recommended Phase 2 Dose (RP2D) levels of APL-5125 in participants with selected advanced solid tumors (Phase 1)		Approximately one year
Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)	Response is assessed per RECIST version 1.1 criteria	Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)

Secondary Outcome Measures	Measure Description	Time Frame
Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)	Response is assessed per RECIST version 1.1 criteria	Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)
Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)	Evaluate PK parameters: oral clearance	On days 1, 2, 4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).
Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)	Evaluate PK parameters: volume of distribution	On days 1, 2 ,4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).
Further assess the anti-tumor activity of APL-5125 (Phase 2)	Response is assessed per RECIST version 1.1 criteria	Response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (Assessed for up to 2 years.)
Incidence of treatment emergent adverse events [Further Safety] (Phase 2)	Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, electrocardiogram results	Through study completion (approximately 2 years)
Further assess the PK of APL-5125 (Phase 2)	Evaluate PK parameters: oral clearance	On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).
Further assess the PK of APL-5125 (Phase 2)	Evaluate PK parameters: volume of distribution	On days 1 and 8 of cycle 1, and on day 1 of cycle 2 and cycle 3 (a cycle is 28 days).

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Apollo Therapeutics

Phone Number: 781-479-2267

Email: AP10@apollotx.com

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 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:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Sanjay Aggarwal, MD, Apollo Therapeutics Ltd

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record