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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
Patients not receiving blood transfusions or granulocyte colony-stimulating factor (G-CSF) within 2 weeks prior to the planned first dosing, with adequate organ function confirmed at screening
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't had blood transfusions or G-CSF shots in the last 2 weeks and my organs work well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 after last dosing.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 after last dosing. for reporting.

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 more

Trial 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.

Find a Location

Who is running the clinical trial?

ABM Therapeutics CorporationLead Sponsor
1 Previous Clinical Trials
112 Total Patients Enrolled

Media Library

ABM-168 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05831995 — Phase 1
Neurofibromatosis Research Study Groups: Experimental Monotherapy Dose Expansion-1, Experimental Monotherapy Dose Escalation, Experimental Monotherapy Dose Expansion-2
Neurofibromatosis Clinical Trial 2023: ABM-168 Highlights & Side Effects. Trial Name: NCT05831995 — Phase 1
ABM-168 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05831995 — Phase 1

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
~67 spots leftby Oct 2025