Title
A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors

Description
A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors

Objective
Primary for Phase 1a:
-To assess the safety and tolerability of BG-C137 in patients with advanced solid tumors.
-To determine the MTD or MAD, and RDFE(s) of BG-C137.

Primary for Phase 1b:
-To determine the RP2D of BG-C137 monotherapy.
-To assess the antitumor activity of BG-C137 monotherapy in patients with selected advanced solid tumors.

Treatment The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.

Key Eligibility Inclusion Criteria:

Histologically or cytologically confirmed advanced or metastatic solid tumors.

Life expectancy of >/= 3 months.

Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Safety Expansion and Dose
Expansion: Participants who have received 1 or 2 prior lines of systemic therapy in the advanced or metastatic setting.

Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of
FGFR2b expression levels and other biomarker assessments.

>/= 1 measurable lesion per RECIST v1.1.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Adequate organ function as determined per protocol.

Applicable Disease Sites
Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital