APL-5125 for Colorectal Cancer

Recruiting at 14 trial locations

Overseen By Apollo Therapeutics

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

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).

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.

Research Team

Sanjay Aggarwal, MD

Principal Investigator

Apollo Therapeutics Ltd

Eligibility Criteria

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.

I am 18 years old or older.

Trial Timeline

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

Treatment Details

Interventions

• APL-5125 (Anti-tumor antibiotic)

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).

Participant Groups

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+