This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1203 in participants with advanced solid tumors.
Able and willing to provide written informed consent and to comply with the study protocol;
Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC;
At least one measurable lesion according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1);
Patients with colorectal cancer must have a microsatellite instability (MSI) test report, and patients with other tumor types must have a prior Programmed Death-Ligand 1 (PD-L1) histopathological examination report; if unavailable, tumor tissue specimens must be provided for the above tests.;
Patients with primary central nervous system tumors or new or symptomatic central nervous system metastases.
Patients with a known history of another malignancy within 5 years prior to signing the informed consent.
Patients with significant cardiovascular and cerebrovascular diseases.
Presence of any of the following within 8 weeks before the first dose: symptomatic radiation pneumonitis, radiation esophagitis, or radiation-induced colitis/proctitis; interstitial lung disease; pulmonary disease with severe obstructive ventilatory impairment; unhealed peptic ulcer; cirrhosis-related complications; chronic enteritis; ischemic necrotizing enteritis; gastrointestinal obstruction; tendency to gastrointestinal bleeding or high risk of gastrointestinal perforation; pancreatitis requiring treatment; arterial or venous thrombotic disease; chronic nephritis; or nephrotic syndrome.
Single group
BA1203
Drugintravenous (IV) once every 2 weeks (Q2W).
Incidence and severity of adverse events (AEs) , immune-related AEs(irAEs), infusion-related reactions (IRRs), AEs of special interest (AESIs)
Incidence and severity of dose limiting toxicities in each dose cohort, and maximum tolerated dose
Recommended phase 2 dose of BA1203
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