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177Lu-BetaBart

Phase 1

Castration-Resistant Prostate Cancer (CRPC) | Small molecule | Oncology |Medpace Holdings, Inc. Common Stock|Last Updated: Oct 1, 2026

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

177Lu-BetaBart · 1 trial · 11 indications

Phase 1 1
NCT07189871177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid TumorsCastration-Resistant Prostate Cancer (CRPC)
RECRUITING61 Analytics
PHASE1RECRUITING
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Castration-Resistant Prostate Cancer (CRPC)
NCT0718987161
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Study Endpoints

Primary Endpoints

Safety and Tolerability of 177LuBetaBart
6 weeks

TEAEs as defined by CTCAE v5.0

To assess the preliminary anti-tumor activity of 177Lu-BetaBart at the RP2D
Up to 30 weeks

ORR per RECIST v1.1 and iRECIST

To assess preliminary anti-tumor activity, as defined by biochemical response, in CRPC participants at the RP2D
Up to 30 weeks

Proportion of participants who achieve a best response of PSA50

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Escalating doses of 177 Lu-BetaBart with or without BetaBart every 6 weeksEXPERIMENTALDose escalation and treatment and imaging period

Interventions

NameTypeDescription
177Lu-BetaBartDRUG177Lu-BetaBart administered intravenously (IV) every 6 weeks at escalating doses
BetaBart + unlabeled BetaBartDRUG177Lu-BetaBart + unlabeled BetaBart administered intravenously (IV) every 6 weeks at escalating doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

1. Participants ≥ 18 years of age. 2. Participants with a documented history of histopathologically confirmed CRPC\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. a. \*Progressive CRPC defined by at least one of the following criteria: i. Two conse...

Countries:United States
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