OncoMatch/Clinical Trials/NCT06814496
Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
Is NCT06814496 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Tarlatamab for melanoma.
Treatment: Tarlatamab — Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting. III) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT. A nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Thyroid Cancer
Urothelial Carcinoma
Testicular Germ Cell Tumor
Glioblastoma
Cervical Cancer
Neuroendocrine Tumor
Small Cell Lung Cancer
Tumor Agnostic
Biomarker criteria
Allowed: DLL3 overexpression
DLL3+ (≥1% by IHC) Note: If patients are DLL3 negative per IHC but have a DLL3 prevalent tumor type, they will be allowed to enroll on the study.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any anti-cancer therapy
Subjects who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care.
Cannot have received: tarlatamab (tarlatamab)
Subject received prior therapy with tarlatamab.
Cannot have received: anti-cancer therapy
Exception: Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1.
Prior anti-cancer therapy within 30 days prior to first dose of tarlatamab.
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Hemoglobin > 9 g/dL (90 g/L)
Kidney function
eGFR > 30 mL/min/1.73 m2 (MDRD calculation)
Liver function
AST, ALT, and ALP < 3 x ULN (or < 5 x ULN for subjects with liver involvement); Total bilirubin < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases)
Cardiac function
Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by ECHO or MUGA, and no clinically significant ECG findings
Adequate organ function, defined as follows: Hematological function: ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Hemoglobin > 9 g/dL (90 g/L); Coagulation: PT/INR and PTT/APTT ≤ 1.5 x ULN; Renal: eGFR > 30 mL/min/1.73 m2; Hepatic: AST, ALT, ALP < 3 x ULN (or < 5 x ULN for subjects with liver involvement); Total bilirubin < 1.5 x ULN (or < 2 x ULN for subjects with liver metastases); Pulmonary: No clinically significant pleural effusion, baseline oxygen saturation > 90% on room air; Cardiac: Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by ECHO or MUGA, and no clinically significant ECG findings
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Cancer Center at UMC North/University Medical Center · Tucson, Arizona
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