ABM-168 for Advanced Solid Tumors

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: ABM Therapeutics Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a Phase 1, First-in-Human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ABM-168 in adult patients with RAS or RAF or NF-1 mutated advanced solid tumors as ABM-168 may have a significant effect in inhibiting cell growth.

Eligibility Criteria

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.

Participant Groups

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.

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.