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Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors

NCT04190628 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-05-21

No results posted yet for this study

Summary

This is a Phase I, First-In-Human, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in adult patients with locally advanced or metastatic solid tumors who have no effective standard treatment options available, as monotherapy in patients with documented BRAF V600 mutation, or in combination with cobimetinib (Cotellic®) in adult patients who have documented BRAF mutation and progressive disease or intolerance to at least one prior line of systemic therapy.

Conditions

  • Advanced Solid Tumor
  • BRAF V600 Mutation

Interventions

DRUG

ABM-1310

Part A: Starting dose at 25 mg by mouth twice daily. Part B: Starting dose at a dose below the MTD( Maximum Tolerated Dose) that has been demonstrated to be safe in Part A. Part C-1 and C-2: Continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part A until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met. Part C-3 and C-4: Continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part B until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.

DRUG

Cobimetinib

Part B: orally administered once daily. Part C-3 and C-4: Continuous once daily oral dose from Part B, administered the first 21 days of each 28-day treatment cycle until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met. Dose formulation is 60 mg capsules.

Sponsors & Collaborators

  • ABM Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

  • Sarina A Piha-Paul, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2024-04-05
Completion
2024-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190628 on ClinicalTrials.gov