APL-5125 for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

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.

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.

+7 more

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

Participant Groups

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).

2Treatment groups

Experimental Treatment

Group I: Phase 2: Dose Expansion/OptimizationExperimental Treatment1 Intervention

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

Group II: Phase 1: Dose EscalationExperimental Treatment1 Intervention

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