OncoMatch/Clinical Trials/NCT07145255
Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors
Is NCT07145255 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ADC for prostate cancer castration-resistant prostate cancer.
Treatment: ADC — This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Breast Carcinoma
Colorectal Cancer
Non-Small Cell Lung Carcinoma
Pancreatic Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: AR-targeted therapy (abiraterone acetate, enzalutamide, apalutamide, darolutamide) — Cohort A (mCRPC)
Patients must have had prior exposure to at least one novel AR-targeted therapy (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide).
Cannot have received: ADC with camptothecin (CPT) payload (trastuzumab deruxtecan, datopotamab deruxtecan, sacituzumab govitecan)
Exception: irinotecan and other non-ADC topoisomerase inhibitors allowed
prior treatment with an ADC with a camptothecin (CPT) payload, such as Enhertu (trastuzumab deruxtecan), Datroway (datopotamab deruxtecan), or Trodelvy (sacituzumab govitecan). Prior treatment with irinotecan and other non-ADC topoisomerase inhibitors is allowed in all phases of the study.
Cannot have received: anticancer therapy
Exception: anti-hormonal therapy for advanced prostate cancer or as adjuvant therapy for early stage, HR positive breast cancer is not considered cancer therapy for the purpose of this protocol
Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy, or any other agents to treat cancer
Cannot have received: investigational drug
Use of any investigational drug within 14 days prior to the first dose of study drug.
Lab requirements
Blood counts
ANC ≥ 1500/uL; Hemoglobin ≥ 9 g/dL; Platelet count ≥ 100,000/uL; INR < 1.5 (or ≤ 3.0 if on therapeutic anticoagulation)
Kidney function
eGFR ≥ 60 mL/min by the CKD-EPI or similar equation or as measured by 24-hour urine collection
Liver function
Total bilirubin ≤ 1.5 × ULN [or ≤ 3-times ULN for patients with Gilbert's disease or documented hepatic tumor involvement]; ALT and AST ≤ 3 × ULN [or ≤ 5-times ULN for patients with documented hepatic tumor involvement]
Cardiac function
QTcF ≤ 470 msec; no NYHA Class III-IV heart failure within 6 months; no recent stroke, TIA, unstable angina, or MI within 6 months
Patient must have adequate organ and marrow function as defined below. ... QTcF > 470 msec or patients with risk factors for Torsades de pointes [excluded]. ... NYHA Class III-IV within 6 months prior to the first dose of study drug [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, California
- START, Midwest · Grand Rapids, Michigan
- START, Astera · East Brunswick, New Jersey
- NEXT, Dallas · Irving, Texas
- START San Antonio · San Antonio, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify