APL-5125 for Colorectal Cancer

Recruiting at 14 trial locations

Overseen By Apollo Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Apollo Therapeutics Ltd

Must be taking: Fluoropyrimidine, Oxaliplatin, Irinotecan, others

Must not be taking: Anticoagulants, Herbal supplements, others

Disqualifiers: Brain metastases, Angina, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called APL-5125 for individuals with advanced colorectal cancer and other specific solid tumors. The goal is to assess the safety and effectiveness of APL-5125 and determine the optimal dose. Participants will include those with colorectal cancer who have previously tried treatments like chemotherapy and certain targeted therapies without success. The trial consists of two parts: one to identify the right dose and another to evaluate its effectiveness at that dose. Ideal candidates are those who have exhausted all standard treatments for colorectal cancer. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any over-the-counter or prescription medications, as well as herbal medicines and supplements, at least 14 days before starting the study. This includes any active anti-cancer treatments and active anti-coagulation therapy.

Is there any evidence suggesting that APL-5125 is likely to be safe for humans?

Research has shown that APL-5125 is under investigation for treating certain advanced solid tumors, such as colorectal cancer. Researchers are still evaluating the safety of this treatment. In the early stages, they focus on patient tolerance and determining the correct dose.

Since APL-5125 is in early testing, information about its safety in humans remains limited. Early trials typically aim to find safe dose levels and monitor for side effects. Doctors and researchers closely observe patient reactions to the treatment. If APL-5125 presents serious safety issues, testing will not continue.

Currently, the primary goal is to ensure APL-5125's safety for people and adjust doses as necessary. Prospective participants should know that safety is a top priority and is monitored throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

Unlike the standard treatments for colorectal cancer, which often include chemotherapy and targeted therapies, APL-5125 is unique because it offers a novel approach with potentially fewer side effects. Researchers are excited about APL-5125 because it targets specific pathways in cancer cells that are not addressed by current therapies, potentially stopping the growth of cancer more effectively. Additionally, APL-5125 may work at different dose levels to optimize treatment, offering a tailored approach for patients, which is a significant step forward in personalized cancer care.

What evidence suggests that APL-5125 might be an effective treatment for colorectal cancer?

Research shows that APL-5125 is under investigation as a potential treatment for colorectal cancer. The trial consists of two phases: a Phase 1 Dose Escalation phase, which tests different dose levels of APL-5125 to determine the Recommended Phase 2 Dose, and a Phase 2 Dose Expansion/Optimization phase, which further evaluates at least two dose levels in a selected population. This treatment targets specific cancer cells, potentially slowing or stopping tumor growth. Early studies focus on safety and dose determination, but initial results show promise in disease control. Patients with similar cancers have experienced longer periods without disease progression using similar treatments. Although more information is needed, these findings suggest that APL-5125 could become a valuable option for colorectal cancer in the future. ^{1 2 3 5 6}

Who Is on the Research Team?

Sanjay Aggarwal, MD

Principal Investigator

Apollo Therapeutics Ltd

Are You a Good Fit for This Trial?

Adults with advanced solid tumors, specifically focusing on colorectal cancer for Phase 2. Participants must be over 18, have an ECOG score of ≤1 indicating they are relatively active, and weigh at least 40 kg. Women must not be pregnant or breastfeeding and agree to use contraception.

Inclusion Criteria

I have been diagnosed with colorectal cancer.

I have received treatments with drugs like 5-FU, oxaliplatin, or irinotecan.

My cancer is advanced and cannot be removed by surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Dose escalation with increasing dose levels of APL-5125 to identify Recommended Phase 2 Dose

8 weeks

Visits on days 1, 2, 4, 8, 15 of cycle 1, and on day 1 of cycle 2 and cycle 3

Phase 2: Dose Expansion/Optimization

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

Up to 2 years

Response assessed every 8 weeks; after one year, every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• APL-5125

Trial Overview APL-5125 is being tested in this open-label trial to assess its safety and effectiveness against various advanced solid tumors, particularly colorectal carcinoma. The study includes two phases: initial safety (Phase 1) and efficacy focus (Phase 2).

How Is the Trial Designed?

Group I: Phase 2: Dose Expansion/Optimization Experimental Treatment 1 Intervention

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

Group II: Phase 1: Dose Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Apollo Therapeutics Ltd

Lead Sponsor

Trials

5

Recruited

330+

Citations

1. dukecancerinstitute.org dukecancerinstitute.org/clinical-trials/apl-5125-gastrointestinal-cancers

APL-5125 (Gastrointestinal Cancers) We are doing this study to find out if an experimental drug called APL-5125 (the study drug) is a safe and effective for people with select types of ...

2. withpower.com withpower.com/trial/phase-2-colorectal-carcinoma-crc-4-2024-6c0a6?condition=breast+cancer&hasNoPlacebo=false&overallStatus=Recruiting

APL-5125 for Colorectal Cancer 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12463852/

Long-term survival benefit from third-line treatment for ... In this case, the patient achieved sustained disease control of more than 38 months with third-line immunotherapy combined with targeted therapy ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06399757

NCT06399757 | A Study to Investigate APL-5125 in Adults ... 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06399757?term=AP10CP01&rank=1

A Study to Investigate APL-5125 in Adults With Advanced ... 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 ...

6. synapse.patsnap.com synapse.patsnap.com/drug/9c3b618639f744649bcce50e0f157208

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