Study of XB002 in Subjects With Solid Tumors

• Status: Recruiting
• Trial end date: 2024-10-07
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, non-randomized, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w as a monotherapy to subjects with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Exelixis

Criteria

Inclusion Criteria:

• Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.

• Dose-Escalation Stage Cohort A and Cohort-Expansion Stage (Cohorts B - G): The subject has received standard life-prolonging therapies unless they do not exist, or available therapies are intolerable or no longer effective.

• Cohort-Expansion Stage Cohort B (Non-small Cell Lung Cancer): Subjects with Stage IV NSCLC who have documented radiographic disease progression during or following their last systemic anticancer therapy.

• Cohort-Expansion Stage Cohort C (Urothelial Cancer): Subjects with transitional cell histology (including renal pelvis, ureter, urinary bladder, urethra) who have documented radiographic disease progression during or following their last systemic anticancer therapy.

• Cohort-Expansion Stage Cohort D (Epithelial Ovarian Cancer): Subjects with epithelial ovarian cancer, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) who have platinum-resistant disease following treatment with platinum-containing chemotherapy. Note: Ovarian borderline epithelial tumors (low malignant potential) are not eligible.

• Cohort-Expansion Stage Cohort E (Cervical Cancer): Subjects with carcinoma of the uterine cervix who have documented radiographic disease progression during or following their last systemic anticancer therapy.

• Cohort F (SCCHN): Subjects with head and neck cancer (squamous cell histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy. Allowed primary tumor locations are oral cavity, oropharynx, hypopharynx, glottic larynx. Note: Excluded are subjects with primary tumor site of the nasopharynx.

• Cohort G (Pancreatic Cancer): Subjects with pancreatic cancer (adenocarcinoma histology) who have documented radiographic disease progression during or following their last systemic anticancer therapy.

• Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1 as determined by the Investigator.

• Tumor tissue material collected approximately 2 years prior to consent. If archival tumor tissue is not available, a fresh tumor biopsy may be collected from subjects enrolled in the Dose-Escalation Stage and must be collected from subjects in the Cohort-Expansion Stage, at least 7 days (and up to 60 days) prior to first dose.

• Recovery to baseline or ≤ Grade 1 severity (Common Terminology Criteria for Adverse Events version 5 [CTCAE v5]) from AEs.

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

• Adequate organ and marrow function.

• Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.

• Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

• Receipt of prior therapies as defined in study protocol

• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.

• Uncontrolled, significant intercurrent or recent illness.

• Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG).

• Pregnant or lactating females

• Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.