A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

Excluded: HER2 (ERBB2) low expression (IHC 1+ or 2+/ISH negative)

Patients with HER2-low cancers (HER2 IHC 1+ or 2+/ISH negative) are excluded

Allowed: BRAF V600 activating mutation

Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor

Allowed: PD-L1 (CD274) expression ≥10% by CPS

if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy

Must have received: anti-PD-1 therapy

Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment

Must have received: platinum-based chemotherapy

Patients must have received prior treatment with platinum-based chemotherapy

Must have received: BRAF inhibitor

Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor

Must have received: MEK inhibitor

Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor

Must have received: sacituzumab govitecan (sacituzumab govitecan)

Patients must have received prior sacituzumab govitecan

Must have received: pembrolizumab with chemotherapy (pembrolizumab)

if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy

Must have received: fam-trastuzumab deruxtecan (fam-trastuzumab deruxtecan)

Patients with HER2-low tumors need to have received fam-trastuzumab deruxtecan (Enhertu)

Must have received: brentuximab vedotin (brentuximab vedotin)

Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor

Cannot have received: anti-PD-1 therapy

Exception: clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment

Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment