A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

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

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