All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

STI-6643 will be provided in a single use 10-mL high borosilicate type 1 glass vial at a concentration of 500mg/10 mL (50 mg/mL) administered intravenously weekly for 4 weeks, then biweekly for Cycles 2 and up.

STI-6643

Mike Royal, MD

Sandip Patel, MD

Staci Vogel

Steven Powell, MD

Timothy Eamma

Reva Schneider, MD

Carrie Friedman, RN

Alexander Spira, MD

This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.

This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.

The study will determine an MTD and RP2D using a conventional 3+3 study design with priming dose identification (PDI) stage and therapeutic dose (TD) escalation (TDE) stage. Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration.

Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Subjects With Advanced Solid Tumors

Safety as assessed by incidence of adverse events, SAEs, DLTs, and clinically significant changes in safety lab results

Anti-drug antibodies directed to STI-6643

Evaluate the pharmacokinetics of STI-6643

Sorrento Therapeutics, Inc.

Antineoplastic Agents

Irinotecan

Immunoconjugates

Immunologic Factors

Intravenous infusion to be given with prophylaxis for infusion reactions, evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, and 24 mg/kg.

Intravenous infusion of STI-3258 will be given (one infusion every three weeks).

STI-3258

This is a phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors.

This is a Phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors including ovarian, breast, lung, esophageal, gastric, hepatocellular and urothelial cancers.

The study will determine any dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), assessing safety and preliminary efficacy using ascending dose cohorts and a conventional 3+3 study design.

To determine DLT and MTD, the design uses a 3+3 ascending dose cohort design evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, 24 mg/kg.

Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors

A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors

Safety as assessed by incidence of adverse events (AEs) by type, frequency, severity, and causality

Safety as assessed by incidence of treatment-emergent AEs (TEAEs) by type, frequency, severity, and causality

Safety as assessed by incidence of serious AEs (SAEs) by type, frequency, severity, and causality

Safety as assessed by incidence of Infusion-related AEs (IrAEs) by type, frequency, severity, and causality

Safety as assessed by incidence of dose-limiting toxicities

To assess the preliminary efficacy of STI-3258 in the treatment of patients with RRSTs based upon Response evaluation criteria in solid tumors (RECIST).

To assess the AUC of STI-3258 in plasma as a measure of exposure to the ADC, STI-3258.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors	NCT04900519	Solid Tumor Relapsed Solid ... Refractory Tumo...	STI-6643	18 Years -	Sorrento Therapeutics, Inc.
Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors	NCT05060276	Relapsed Solid ... Refractory Canc... Solid Tumor, Ad...	STI-3258	18 Years -	Sorrento Therapeutics, Inc.

Spots Global Cancer Trial Database for relapsed solid neoplasm