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Recruiting NCT05532696

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

Phase I / Phase II Interventional Advanced Solid Tumor Non Small Cell Lung Cancer HER2 Mutations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABT-101.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Non Small Cell Lung Cancer, HER2 Mutations. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib/II, Open-Label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ABT-101 in Patients With Advanced Solid Tumors and HER2 Exon 20 Insertions Mutated Non- Small Cell Lung Cancer

Overview

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)

Detailed description

This study will be conducted in two parts:

Part 1: Dose- Escalation, Phase 1b, is designed to determine the RP2D. Patients with solid tumor will be enrolled into a dose finding study scheme with the assessment of dose-limiting toxicities (DLTs). DLT assessment will be conducted during treatment cycle 1

Part 2: Dose- Expansion, Phase 2, will evaluate the safety and efficacy of ABT-101 at the dosage and dosing regime determined in Phase 1b. Phase 2 will enroll NSCLC patients with HER2 mutations

Study participation for all patients includes screening period, treatment period and safety/ follow-up period. Patient will received study treatment until progressive disease or any other discontinuation or withdrawal criterion is met

Interventions

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

Primary outcome measures

  • Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1 [Time frame: 18 months]
  • Determine antitumor activity based on Objective Response Rate (ORR) in Part 2 in patients with NSCLC with targeted mutation [Time frame: 36 months]
Secondary outcome measures (7)
  • Maximum plasma concentration (Cmax) ABT-101 [Time frame: 48 months]
  • Area under the plasma concentration time curve (AUC) of ABT-101 [Time frame: 48 months]
  • Duration of response (DOR) [Time frame: 48 months]
  • Progression- free survival (PFS) [Time frame: 36 months]
  • Overall survival (OS) [Time frame: 36 months]
  • Objective response rate (ORR) in Part 1 [Time frame: 12 months]
  • Disease control rate (DCR) [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • 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)
  • Appropriate candidate for experimental therapy
  • Adequate organ function

Exclusion criteria

  • 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
  • Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
  • Not recovered from prior- treatment toxicities to Grade ≤1
  • Major surgery within 28 days prior to the study treatment
  • Concurrent malignancy within 2 years prior to first dose
  • History or presence of clinically relevant cardiovascular abnormalities. QTcF ≥ 470 ms
  • Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101
  • Known to have a history of alcoholism or drug abuse

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 5 centers
  • Taichung Veterans General Hospital — Taichung
  • National Cheng Kung University Hospital — Tainan
  • National Taiwan University Hospital — Taipei
  • Taipei Medical Univresity Hospital — Taipei
  • Chang Gung Memorial Hospital, Linkou — Taoyuan

Identifiers

NCT: NCT05532696 · ABT101-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗