177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

NCT07189871 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BetaBart-US-101
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors

Conditions

Castration-Resistant Prostate Cancer (CRPC); Colorectal Cancer; NSCLC (Non-small Cell Lung Cancer); Ovarian Cancer; Cervical Cancer; Endometrial Cancer; TNBC, Triple Negative Breast Cancer; Small Cell Lung Cancer (SCLC ); Head &Amp; Neck Squamous Cell Carcinoma (HNSCC); Esophageal Squamous Cell Carcinoma (ESCC); Sarcoma

Keywords

Castration-resistant prostate cancer (CRPC); colorectal cancer (CRC); non-small-cell lung cancer (NSCLC); small-cell lung cancer (SCLC); head and neck squamous cell carcinoma (HNSCC); ovarian cancer; cervical cancer; endometrial cancer; triple negative breast cancer (TNBC); esophageal squamous cell carcinoma (ESCC); B7-H3; 177Lu; radiotheranostics; radioligand therapy; radioimmunotherapy; monoclonal antibody; metastatic solid tumors; sarcoma

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability of 177LuBetaBart

  TEAEs as defined by CTCAE v5.0

  6 weeks

• To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D

  ORR per RECIST v1.1 and iRECIST

  Up to 30 weeks

• To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants at the RP2D

  Proportion of participants who achieve a best response of PSA50

  Up to 30 weeks

Secondary Outcomes (7)

• To assess the preliminary anti-tumor activity of 177Lu-BetaBart

  Up to 30 weeks

• To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants

  Up to 30 weeks

• Assess biodistrubution, PK, and radiation dosimetry of 177Lu-BetaBart

  6 weeks

• Effect of Co-injection of unlabeled BetaBart on biodistribution of radiolabeled 177Lu-BetaBart

  6 weeks

• To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants who were previously treated with at least one ARSI

  Up to 30 weeks

Study Arms (1)

Escalating doses of 177 Lu-BetaBart with or without BetaBart every 6 weeks

EXPERIMENTAL

Dose escalation and treatment and imaging period

Drug: 177Lu-BetaBart; Drug: BetaBart + unlabeled BetaBart

Interventions

177Lu-BetaBart DRUG

177Lu-BetaBart administered intravenously (IV) every 6 weeks at escalating doses

Also known as: RV-01

Escalating doses of 177 Lu-BetaBart with or without BetaBart every 6 weeks

BetaBart + unlabeled BetaBart DRUG

177Lu-BetaBart + unlabeled BetaBart administered intravenously (IV) every 6 weeks at escalating doses

Escalating doses of 177 Lu-BetaBart with or without BetaBart every 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History of prior organ transplant.
• Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer.
• Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures.
• Residual toxicity ≥ Grade 2 from prior anti-cancer therapy
• History of uncontrolled allergic reactions and/or known or expected hypersensitivity to protein therapeutics.
• Inadequate organ functions as reflected in laboratory parameters:
• Estimated glomerular filtration rate (eGFR) \< 50 mL/min
• Platelet count of \< 100 x 109/L
• Absolute neutrophil count (ANC) \< 1.5 x 109/L
• Hemoglobin \< 9 g/dL
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN), or \> 5 x ULN for participants with known liver metastases
• Total bilirubin \> 1.5 x ULN
• Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart.
• \*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.
• Clinically significant cardiovascular disease

Sponsors & Collaborators

• Radiopharm Theranostics, Ltd: lead
• Medpace, Inc.: collaborator

Study Sites (5)

Dothan Hematology & Oncology

Dothan, Alabama, 36303, United States

RECRUITING

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

XCancer

Omaha, Nebraska, 68130, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Triple Negative Breast Neoplasms; Small Cell Lung Carcinoma; Esophageal Squamous Cell Carcinoma; Sarcoma; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Connective and Soft Tissue

Central Study Contacts

Dimitris Voliotis, MD

CONTACT

646-535-5017; dv@radiopharmtheranostics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: BOIN dose escalation during Phase 1 followed by dose expansion at RP2D during Phase 2a

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 24, 2025
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)