OncoMatch/Clinical Trials/NCT06389123
Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas
Is NCT06389123 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. for metastatic cancer.
Treatment: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. — This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: ITGB6 expression (SUVmax >2-fold above normal bone, brain, lung or liver)
The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — metastatic disease
Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL
Kidney function
Creatinine ≤ 2 times ULN
Liver function
AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN); Total bilirubin ≤ 2 times ULN
Cardiac function
Participants with Class 3 or 4 NYHA Congestive Heart Failure [excluded]
Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL; Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN; Participants with Class 3 or 4 NYHA Congestive Heart Failure [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06389123 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require ITGB6?
Yes, ITGB6 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify