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OncoMatch/Clinical Trials/NCT06788938

Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms

Is NCT06788938 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tarlatamab treatment for dll3-expressing tumors.

Phase 2RecruitingJonsson Comprehensive Cancer CenterNCT06788938Data as of May 2026

Treatment: Tarlatamab treatmentThis study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study.

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Extracted eligibility criteria

Biomarker criteria

Required: DLL3 overexpression (≥25% (Stage 1) or ≥1% (Stage 2) by IHC)

Positive DLL3 expression by immunohistochemistry on tumor biopsy. Positive DLL3 expression, for purposes of this study, defined as at least 25% for participants enrolling into Stage 1 or 1% for participants enrolling into Stage 2.

Disease stage

Required: Stage IV, III

Metastatic disease required

Must be stage IV (metastatic); participants with stage III disease are eligible provided that they are not candidates for surgery and/or radiotherapy with curative intent. Measurable disease, as per RECIST 1.1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard of care therapy — if a standard of care therapy exists for the tumor type

Participants must have progressed on or following at least one line of therapy, if a standard of care therapy exists for the tumor type.

Cannot have received: selective inhibitor of the DLL3 pathway

Prior therapy with any selective inhibitor of the DLL3 pathway.

Lab requirements

Blood counts

ANC ≥ 1.0 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL

Kidney function

eGFR (MDRD) ≥ 30 mL/min/1.73 m2

Liver function

Serum total bilirubin ≤ 1.5 x ULN (except Gilbert's disease); AST (SGOT) and ALT (SGPT) ≤ 3 x ULN (≤ 5 x ULN for patients with liver metastasis or primary liver cancer)

Adequate organ function as defined in Table 3 below. Hematological: ANC ≥ 1.0 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL. Renal: eGFR (MDRD) ≥ 30 mL/min/1.73 m2. Hepatic: Serum total bilirubin ≤ 1.5 x ULN (except Gilbert's disease); AST (SGOT) and ALT (SGPT) ≤ 3 x ULN (≤ 5 x ULN for patients with liver metastasis or primary liver cancer).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UC Davis Comprehensive Cancer Center · Davis, California
  • UCI Health Chao Family Comprehensive Cancer Center · Irvine, California
  • University of California at Los Angeles · Los Angeles, California
  • UC San Diego Moores Cancer Center · San Diego, California
  • University of California at San Francisco · San Francisco, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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