OncoMatch/Clinical Trials/NCT04657068
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Is NCT04657068 recruiting? Yes, currently enrolling (Jun 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 loss
alterations to the ATM gene likely to predict for loss of ATM protein
Excluded: UGT1A1 *6/*6 and *28/*28 (homozygous), or *6/*28 (compound heterozygous)
Patients who are known to be homozygous for both UGT1A1 *6 and *28 (UGT1A1 7/7 genotype), or simultaneously heterozygous for both UGT1A1 *6 and *28
Allowed: BRCA1 mutation
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
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 — if approved for BRCA/HRD+ cancer
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: platinum-based chemotherapy — endometrial and ovarian/fallopian/peritoneal carcinoma
Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy).
Must have received: taxane — endometrial carcinoma
Patients should have received taxane/platinum chemotherapy, unless contraindicated.
Must have received: bevacizumab (bevacizumab) — ovarian/fallopian/peritoneal carcinoma
Patients should have previously received bevacizumab and chemotherapy unless contra-indicated.
Must have received: PD-1/PD-L1 inhibitor (pembrolizumab) — if approved and available for the patient's cancer
If a PD-1/PDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.
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 loss is a required biomarker for enrollment.
Are patients with UGT1A1 alterations eligible?
No. UGT1A1 *6/*6 and *28/*28 (homozygous), or *6/*28 (compound heterozygous) is an exclusion criterion.
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