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Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

ConditionsAdvanced Solid TumorNon Small Cell Lung CancerHER2 Mutations
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnbogen Therapeutics, Inc.

About this trial

A Phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged ≥ 20 years or adult age as per local regulations, at time of informed consent

Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2)

For patients in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Part 1), 0 to 2 (Part 2)

Disqualifiers

Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.

Serious acute or chronic infections

Received a live-virus vaccination

Trial design

Design model

Single group

Treatments tested in this trial

  • ABT-101

    Drug

    Patients will receive ABT-101 by oral administration on a 28-day cycle

Treatment groups

61 Participants
are divided into 1 treatment group
Group A: ABT-101Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1

Determine the maximum tolerated dose (MTD) and RP2D of ABT-101 based on Dose Limiting Toxicities

Time frame
18 months
2

Determine antitumor activity based on Objective Response Rate (ORR) in Part 2 in patients with NSCLC with targeted mutation

Patients response according to RECIST 1.1

Time frame
36 months

Secondary outcomes

1

Maximum plasma concentration (Cmax) ABT-101

Plasma concentration of ABT-101

Time frame
48 months
2

Area under the plasma concentration time curve (AUC) of ABT-101

Measure of AUC

Time frame
48 months
3

Duration of response (DOR)

DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death

Time frame
48 months
4

Progression- free survival (PFS)

Measure of the time from study entry to disease progression or death due to any cause

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anbogen Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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