OncoMatch/Clinical Trials/NCT06751329
A Study of DM002 in Patients With Advanced Solid Tumors
Is NCT06751329 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies DM002 for ovarian neoplasms.
Treatment: DM002 — The goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you. The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers. In Part 2, participants will receive the best dose level that was determined in Part 1 of the study. The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug. Participants will: Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Prostate Cancer
Endometrial Cancer
Colorectal Cancer
Biomarker criteria
Required: ERBB3 any tested (testing required; no eligibility threshold specified)
Required: MUC1 any tested (testing required; no eligibility threshold specified)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anticancer therapy
Exception: hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels
Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose.
Cannot have received: radiation therapy
Exception: limited field of radiation for palliation within 14 days
Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose.
Cannot have received: major surgery
Exception: diagnostic surgery
Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.
Cannot have received: antibody-drug conjugate with topoisomerase I payload
Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload
Cannot have received: investigational drug
treatment history with any investigational drug within 4 weeks before enrolment in the study
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9 g/dL
Kidney function
Calculated creatinine clearance (CrCL) >60 mL/min (Cockroft-Gault Equation)
Liver function
Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤3.0 × ULN, if liver metastases are present, ≤5 × ULN
Cardiac function
Left ventricular ejection fraction <50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug [excluded]
Participants must meet the following laboratory values within 7 days prior to first dose of study drug: ... Left ventricular ejection fraction <50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Oklahoma Health Sciences Center · Oklahoma City, Oklahoma
- The University of Texas, MD Anderson Cancer Center · Houston, Texas
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