OncoMatch/Clinical Trials/NCT06154291
FIH XON7 in Advanced/Metastatic Solid Tumors
Is NCT06154291 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies XON7 for advanced solid tumor.
Treatment: XON7 — This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
advanced or metastatic solid tumors; Measurable disease per RECIST version 1.1 - v5
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: targeted therapy — if molecular alteration present and standard of care
Participants whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority-approved appropriate targeted therapy for their tumor types before enrollment.
Cannot have received: anti-cancer monoclonal antibody
Exception: within 3 weeks prior to trial Day 1
prior anti-cancer mAb within 3 weeks prior to trial Day 1
Cannot have received: chemotherapy
Exception: within 2 weeks prior to trial Day 1
prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1
Cannot have received: targeted small molecule therapy
Exception: within 2 weeks prior to trial Day 1
prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1
Cannot have received: radiation therapy
Exception: within 2 weeks prior to trial Day 1
prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1
Cannot have received: immunotherapy
Exception: ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation
≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation
Cannot have received: bone marrow transplantation
Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
Cannot have received: solid organ transplantation
Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
QTcF <450 msec or <480 msec for participants with bundle branch block; no recent serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities; no documented cardiomyopathy, myocardial infarction, acute coronary syndromes, coronary angioplasty, stenting, or bypass grafting within past 6 months; no documented congestive heart failure (NYHA II-IV)
Adequate organ function; QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 msec or <480 msec for participants with bundle branch block. Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third-degree atrioventricular block. Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment. Documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system (NYHA, 1994).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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