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ABM-168 for Advanced Solid Tumors
Phase 1
Recruiting
Research Sponsored by ABM Therapeutics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 after last dosing.
Awards & highlights
Study Summary
This trial will assess a new drug's safety, tolerability and effectiveness for advanced solid tumors with mutations in RAS, RAF or NF-1.
Who is the study for?
Adults with advanced solid tumors that have RAS, RAF or NF-1 mutations can join this trial if they've tried all standard treatments or those aren't suitable. They must be over 18, able to consent, and expected to live at least 3 more months. Stable brain tumors are okay if they meet certain conditions. Participants need good performance scores, no recent blood transfusions or growth factors, proper organ function, not pregnant or breastfeeding, agree to use contraception and can swallow capsules.Check my eligibility
What is being tested?
ABM-168 is being tested in adults with specific genetic mutations in their tumors. This Phase 1 trial will gradually increase doses to find a safe level and then expand the study to see how well it works against tumor growth by inhibiting cell activity.See study design
What are the potential side effects?
As ABM-168 is a new drug being evaluated for the first time in humans (First-in-Human), potential side effects are unknown but may include typical reactions seen with cancer therapies such as nausea, fatigue, allergic reactions and possibly effects on blood counts or organ functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28 after last dosing.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 after last dosing.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine Dose Limiting Toxicity (DLT) and/or Recommended Phase 2 dose (RP2D)
Safety and tolerability, severity per Common Toxicity Criteria for Adverse Events (CTCAE v5.0)
Safety and tolerability-AE causality.
+12 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Experimental Monotherapy Dose Expansion-2Experimental Treatment1 Intervention
Expansion will be conducted in the adult patients with advanced solid tumors that carry either RAS, RAF or NF-1 mutations. Cohort EX2 will enroll the patients who had primary CNS tumors with confirmed RAS, RAF or NF-1 mutations at baseline. Up to 30 evaluable patients will be enrolled.
Group II: Experimental Monotherapy Dose Expansion-1Experimental Treatment1 Intervention
Expansion will be conducted in the adult patients with advanced solid tumors that carry either RAS, RAF or NF-1 mutations. Cohort EX1 will enroll the patients with preferred indications (i.e., melanoma, colon cancer, lung cancer, and pancreatic carcinoma) who had confirmed RAS, RAF or NF-1 mutations and measurable target lesion(s) at baseline. Patients with measurable brain metastases lesion(s) at baseline are highly preferred. Up to 15 evaluable patients will be enrolled for each into each preferred indication. Other indication(s) that show confirmed response, complete response (CR) or partial response (PR) in at least one subject in the dose escalation study will facilitate the preferred indication(s) for Cohort EX1 enrollment as well.
Group III: Experimental Monotherapy Dose EscalationExperimental Treatment1 Intervention
A classic "3+3" design will be used to explore the maximum tolerated dose (MTD) and to determine the recommended phase II dose (RP2D). Three to four patients will be enrolled to ensure at least 3 evaluable patients for DLT (Dose Limiting Toxicity). ABM-168 monotherapy will be conducted in seven provisional dose levels starting at 0.5mg oral administration per day and up to and including 12mg oral administration. Each treatment cycle is 28-days. DLT will be evaluated in the first 28-day cycle. Patients will receive daily doses of ABM-168 until disease progression; intolerable toxicity; withdrawal consent; or other clinical observation is met.
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Who is running the clinical trial?
ABM Therapeutics CorporationLead Sponsor
1 Previous Clinical Trials
112 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breast-feeding.I haven't had blood transfusions or G-CSF shots in the last 2 weeks and my organs work well.I have brain cancer or brain metastases, can care for myself, and am expected to live at least 3 more months.I have heart problems or significant heart disease.I am 18 or older and can follow study rules.I have at least one tumor that can be measured on scans.I do not have high blood pressure, severe diarrhea, eye diseases, or serious infections needing IV antibiotics.I have a cancer lesion that can be evaluated but not measured.I haven't had organ or bone marrow transplants, extensive cancer treatments, or unresolved side effects in the last 5 years.I have not had a stroke or leptomeningeal disease in the last 6 months.My advanced cancer has not responded to or is unsuitable for standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Monotherapy Dose Expansion-1
- Group 2: Experimental Monotherapy Dose Escalation
- Group 3: Experimental Monotherapy Dose Expansion-2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this clinical investigation?
"Affirmative. Information found on clinicaltrials.gov attests to the fact that recruitment for this trial is currently underway, having first been posted on March 30th 2023 and most recently updated April 14th of the same year. This study requires 112 participants in total, sourced from a pair of locations."
Answered by AI
What potential risks have been observed with Experimental Monotherapy Dose Escalation?
"With minimal clinical data to support safety and efficacy, Experimental Monotherapy Dose Escalation received a score of 1."
Answered by AI
Are there any openings available for participants in this experiment?
"Affirmative. Clinicaltrials.gov evidences that this clinical trial, which was posted on March 30th 2023, is still searching for participants. 112 patients need to be sourced from 2 separate medical centres."
Answered by AI
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