177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic S… (NCT07189871) | Clinical Trial Compass
RecruitingPhase 1/2
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
United States61 participantsStarted 2026-02-23
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \< 50 years of age who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.
✕. Participants of CBP must agree to use a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4.
What they're measuring
1
Recommended dose(s) of 177Lu-BetaBart for future exploration (phase 1)
Timeframe: 6 weeks
2
Incidence of treatment emergent adverse events of 177-Lu-BetaBart (phase 1) (Safety and Tolerability)
Timeframe: 6 weeks
3
To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D (phase 2a)
Timeframe: Up to 30 weeks
4
To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants who are treated with 177Lu-BetaBart at the RP2D (phase 2a)
✕0. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4. All male participants must agree to not donate sperm during the study and for 6 months after the last dose of 177Lu-BetaBart.
✕1. Participants who have received prior radiation therapy \>28 days before the first dose of 177Lu-BetaBart are permitted. Documentation of the dates the radiotherapy was received, the cumulative dose, and the absorbed dose to critical organs, if available, should be provided.