A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors

Required: ESR1 negative (IHC ER < 1%) (IHC ER < 1%)

ER negative is defined as: IHC ER < 1%

Required: PR (PGR) negative (IHC PR < 1%) (IHC PR < 1%)

PR negative is defined as: IHC PR < 1%

Required: HER2 (ERBB2) negative (IHC HER-2 (-) or (1+); if (2+), FISH negative) (IHC HER-2 (-) or (1+); if (2+), FISH negative)

HER-2 negative is defined as: IHC HER-2 (-) or (1+). Patients with HER-2 (2+) must undergo FISH testing and the result is negative

Must have received: standard of care

(Dose escalation + PK bridging) Relapsed and/or progressed at least one prior line of standard of care, or have no available standard of care, or are intolerable to standard of care, or have no further approved treatment options available

Must have received: platinum-based chemotherapy — endometrial cancer

Cohort C (endometrial cancer): ...disease has relapsed or progressed after at least 1-line of platinum-based chemotherapy regimen or 1-line of immunotherapy-containing regimen

Must have received: immunotherapy — endometrial cancer

Cohort C (endometrial cancer): ...disease has relapsed or progressed after at least 1-line of platinum-based chemotherapy regimen or 1-line of immunotherapy-containing regimen

Must have received: platinum-based chemotherapy — NSCLC

Cohort D (NSCLC): ...1-line platinum-doublet chemotherapy and anti-PD-1/PD-L1 combination at the same time, ...at least 1-line treatment in the past and totally no more than 4 lines of treatment regimen; ...platinum-doublet chemotherapy sequentially and anti-PD-1/PD-L1, ...at least 2-line treatment and totally no more than 4 lines of treatment regimen

Must have received: anti-PD-1 therapy — NSCLC

Cohort D (NSCLC): ...1-line platinum-doublet chemotherapy and anti-PD-1/PD-L1 combination at the same time, ...at least 1-line treatment in the past and totally no more than 4 lines of treatment regimen; ...platinum-doublet chemotherapy sequentially and anti-PD-1/PD-L1, ...at least 2-line treatment and totally no more than 4 lines of treatment regimen

Must have received: anti-PD-L1 therapy — NSCLC

Cohort D (NSCLC): ...1-line platinum-doublet chemotherapy and anti-PD-1/PD-L1 combination at the same time, ...at least 1-line treatment in the past and totally no more than 4 lines of treatment regimen; ...platinum-doublet chemotherapy sequentially and anti-PD-1/PD-L1, ...at least 2-line treatment and totally no more than 4 lines of treatment regimen

Must have received: targeted therapy — NSCLC with genetic mutations

Cohort D (NSCLC): People with genetic mutations: Received at least 1-line approved targeted therapy, and previously no more than 4 lines of treatment regimen

Must have received: systemic anticancer therapy — triple-negative breast cancer

Cohort E (triple-negative breast cancer): ...previously received at least 1 line but no more than 4 lines of systemic anticancer therapy

Cannot have received: antibody-drug conjugate (ADC) containing tubulin inhibitors (mirvetuximab, XMT-1536)

Prior treatment with ADCs containing tubulin inhibitors (e.g., mirvetuximab of Immunogen, XMT-1536 of Mersana, which contains auristain derivatives that inhibit tubulin polymerization)

Cannot have received: FolRα-targeting drugs

Previous treatment with other FolRα-targeting drugs

Cannot have received: chemotherapy

Prior anticancer therapy (prior to initial dose of study drug): Chemotherapy within 3 weeks

Cannot have received: PARP inhibitor

Prior anticancer therapy (prior to initial dose of study drug): PARPi within 2 weeks

Cannot have received: therapeutic anticancer antibody

Prior anticancer therapy (prior to initial dose of study drug): other therapeutic anticancer antibodies within 3 weeks

Cannot have received: radio- or toxin-immunoconjugate (such as ADCs)

Prior anticancer therapy (prior to initial dose of study drug): radio- or toxin-immunoconjugate (such as ADCs) within 10 weeks

Cannot have received: Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications

Prior anticancer therapy (prior to initial dose of study drug): Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 week

Cannot have received: radiation therapy

Prior anticancer therapy (prior to initial dose of study drug): radion therapy/major surgery within 4 weeks

Cannot have received: major surgery

Prior anticancer therapy (prior to initial dose of study drug): major surgery within 4 weeks (the definition of surgery refers to Grade 3-4 surgeries specified in the Measures for the Grade Management of Surgery in Medical Institutions issued by the National Health Commission of the PRC on December 06, 2022) or are in the recovery period from surgery (the investigator judges that there are still risks in participating the clinical study)