OncoMatch/Clinical Trials/NCT04657068
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Is NCT04657068 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including ART0380 and Gemcitabine for advanced cancer.
Treatment: ART0380 · Gemcitabine · Irinotecan — This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Tumor Agnostic
Ovarian Cancer
Endometrial Cancer
Colorectal Cancer
Pancreatic Cancer
Biomarker criteria
Required: ATM alteration likely to predict for loss of atm protein
Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein
Required: ATM alteration
Metastatic CRC with alterations to the ATM gene
Required: ATM alteration
Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene
Allowed: BRCA1 mutation
If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated
Allowed: BRCA2 mutation
If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: PARP inhibitor — BRCA-mutant or HRD-positive cancer with approved PARP inhibitor
If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated
Must have received: gemcitabine (gemcitabine) — Part A2: advanced or metastatic cancer for which gemcitabine is appropriate
Prior treatment with gemcitabine is permitted
Must have received: irinotecan (irinotecan) — Part A3: advanced or metastatic cancer for which irinotecan is appropriate
Prior treatment with irinotecan is permitted
Must have received: taxane/platinum chemotherapy — endometrial cancer
Patients should have received taxane/platinum chemotherapy, unless contraindicated
Must have received: bevacizumab and chemotherapy (bevacizumab) — high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum
Patients should have previously received bevacizumab and chemotherapy unless contra-indicated
Cannot have received: gemcitabine (gemcitabine)
Exception: unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen
Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen
Lab requirements
Blood counts
Acceptable hematologic function independent of transfusions and granulocyte colony-stimulating factor
Kidney function
Acceptable renal function independent of transfusions and granulocyte colony-stimulating factor
Liver function
Acceptable hepatic function independent of transfusions and granulocyte colony-stimulating factor
Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Mayo Clinic (Arizona) · Scottsdale, Arizona
- University of Arkansas - Winthrop P. Rockefeller Cancer Institute · Little Rock, Arkansas
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- Sansum Clinic · Santa Barbara, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04657068 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gemcitabine disqualifies patients from enrollment.
Does this trial require ATM?
Yes, ATM alteration likely to predict for loss of atm protein is a required biomarker for enrollment.
Does this trial require ATM?
Yes, ATM alteration is a required biomarker for enrollment.
Does this trial require ATM?
Yes, ATM alteration is a required biomarker for enrollment.
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 qualifyRelated pages