OncoMatch/Clinical Trials/NCT05720130
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
Is NCT05720130 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including [²¹²Pb]Pb-ADVC001 (Phase 1b) and [²¹²Pb]Pb-ADVC001 (Phase 2a) for prostate cancer.
Treatment: [²¹²Pb]Pb-ADVC001 (Phase 1b) · [²¹²Pb]Pb-ADVC001 (Phase 2a) — This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of \[212Pb\]Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) and establish the recommended phase 2 doses (RP2D). The Phase 2a expansion aims to assess the efficacy and safety of \[212Pb\]Pb-ADVC001 at the RP2 doses in 3 participant groups.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 overexpression (PSMA PET uptake greater than normal liver)
Has disease that is prostate specific membrane antigen (PSMA) positive, as demonstrated by ⁶⁸Ga-PSMA-PET/CT or ¹⁸F-based PSMA PET/CT and confirmed as eligible by local reader. PSMA-positive participants are defined as those having at least one tumor lesion with ⁶⁸Ga- or ¹⁸F- PSMA PET CT uptake greater than normal liver (based on visual assessment) and all tumor lesions larger than size criteria with ⁶⁸Ga- or ¹⁸F-PSMA uptake greater than liver [short axis size criteria: organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component) ≥ 1 cm].
Excluded: BRCA1 pathogenic mutation
Has a known alteration in breast cancer genes (BRCA) BRCA1 or BRCA2 and are eligible to receive poly ADP ribose polymerase (PARP) inhibitor therapy according to their treating institution's standard of care.
Excluded: BRCA2 pathogenic mutation
Has a known alteration in breast cancer genes (BRCA) BRCA1 or BRCA2 and are eligible to receive poly ADP ribose polymerase (PARP) inhibitor therapy according to their treating institution's standard of care.
Disease stage
Required: Stage IV
Metastatic disease required
Documented metastatic adenocarcinoma of the prostate
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen receptor pathway inhibitor
exposure to at least one ARPi
Must have received: taxane
taxane-based chemotherapy at any time in the course of their disease (unless taxanes considered contraindicated or declined by participant as documented in the patient's source documents and eCRF)
Cannot have received: systemic radioligand therapy
Exception: prior radium-223 allowed; prior 177Lu-PSMA required for Phase 2a Group 3
Has received prior systemic radioligand therapy with the exception of prior radium-223. Prior 177Lu-PSMA is required for Phase 2a Group 3 participants.
Cannot have received: systemic anti-cancer therapy
Exception: within four weeks of C1D1
Systemic anti-cancer therapy and/or radiation therapy within four weeks of C1D1 or has received any investigational agent within four weeks of C1D1.
Lab requirements
Blood counts
Adequate haematological function
Kidney function
Adequate renal function
Liver function
Adequate liver function
Adequate haematological, renal, and liver function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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