Health Trials

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

ConditionsCastration-Resistant Prostate Cancer (CRPC)Colorectal CancerNSCLC (Non-small Cell Lung Cancer)Ovarian CancerCervical CancerEndometrial CancerTNBC, Triple Negative Breast CancerSmall Cell Lung Cancer (SCLC )Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)Esophageal Squamous Cell Carcinoma (ESCC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadiopharm Theranostics, Ltd

About this trial

A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Eligibility criteria

Qualifiers

Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.

Participants ≥ 18 years of age.

Participants with a documented history of histopathologically confirmed CRPC*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or

Disqualifiers

Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. Any number of prior treatment lines are allowed.

Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.

Trial design

Treatments tested in this trial

  • 177Lu-BetaBart

Treatment groups

61 Participants
are divided into 1 treatment group

Locations

4
Dothan Hematology & Oncology36303, DothanAlabama, United States
BAMF Health49503, Grand RapidsMichigan, United States
Nebraska Cancer Specialists68130, OmahaNebraska, United States
XCancer68130, OmahaNebraska, United States

Sponsors and collaborators

Radiopharm Theranostics, Ltd

Lead sponsor

Medpace, Inc.

Collaborator

Source ClinicalTrials.gov