Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
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
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
Treatments tested in this trial
- ABT-101
Treatment groups
61 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov