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Anti-tumor antibiotic
APL-5125 for Colorectal Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Apollo Therapeutics Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 2: Colorectal carcinoma
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up response is assessed every 8 weeks; after one year of treatment, response is assessed every 12 weeks. (assessed for up to 2 years.)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety, side effects, and effectiveness of a drug called APL-5125 for treating advanced solid tumors, specifically focusing on colorectal cancer.
Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
While specific side effects of APL-5125 are not listed here, common ones for cancer treatments include nausea, fatigue, risk of infection due to lowered immunity, hair loss, skin reactions at the injection site, and potential organ-related toxicities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with colorectal cancer.
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I have received treatments with drugs like 5-FU, oxaliplatin, or irinotecan.
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I am 18 years old or older.
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My cancer is advanced and cannot be removed by surgery.
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My cancer is RAS wild-type, making me eligible for anti-EGFR therapy.
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I am fully active and can carry on all pre-disease activities without restriction.
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I weigh at least 40 kg.
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I am currently taking or have taken anti-VEGF therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assess the anti-tumor activity of APL-5125 in patients with Colorectal carcinoma (Phase 2)
Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1)
Incidence of dose limiting toxicities [Tolerability] (Phase 1)
Secondary study objectives
Assess the pharmacokinetics (PK) of APL-5125 (Phase 1)
Assess the preliminary anti-tumor activity of APL-5125 in colorectal carcinoma patients (Phase 1)
Further assess the PK of APL-5125 (Phase 2)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Dose Expansion/OptimizationExperimental Treatment1 Intervention
Up to 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
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Who is running the clinical trial?
Apollo Therapeutics LtdLead Sponsor
3 Previous Clinical Trials
177 Total Patients Enrolled
Sanjay Aggarwal, MDStudy ChairApollo Therapeutics Ltd
2 Previous Clinical Trials
382 Total Patients Enrolled
Daniela Pignataro, MDStudy ChairApollo Therapeutics Ltd
1 Previous Clinical Trials
112 Total Patients Enrolled
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